Pfizer
Muscles & bones symptom reports
Female, 60 - 75 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 60 | 2021-01-04 | muscle pain | tired Chills Muscle aches Throat irritation weakness no energy hot flashes |
| 60 | 2021-01-05 | joint pain, muscle pain |
On day 1 after the vaccine the employee began having muscle aches and sore joints. By day 4 she fel...
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On day 1 after the vaccine the employee began having muscle aches and sore joints. By day 4 she felt like she had an improvement in symptoms. On day 6 the same symptoms reappeared and the employee was tested for COVID (negative PCR). She reports that all of her joints in bilateral upper and lower extremities are extremely sore, she noted that "even her toes were painful". She is unable to take NSAIDS because of a history of anaphylactic reaction to Motrin in the past.
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| 60 | 2021-01-05 | joint pain |
I have had a fever ranging from 100.1 to 100.5 since 7 pm on the day I received the 2nd dose vaccine...
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I have had a fever ranging from 100.1 to 100.5 since 7 pm on the day I received the 2nd dose vaccine on 1/4/2021. Symptoms include extreme body aches, joint aches, and headache. Today is 1/6/2021 my temp at 7:30 am was 100.3. I have had to miss work yesterday and today so far.
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| 60 | 2021-01-05 | joint pain |
Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in b...
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Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.
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| 60 | 2021-01-05 | muscle pain |
INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINES...
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INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.
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| 60 | 2021-01-05 | muscle pain |
Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscl...
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Dizzy right after vaccine, foggy increased through evening, tired in the evening of injection, muscle aches, headache, and nausea about 2am, fever 99.8 at 1pm on 1/6/21. All these symptoms still persist now 5:40pm 1/6/20
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| 60 | 2021-01-06 | joint pain, muscle pain | Extreme fatigue, muscle aches ,joint pain. Have slight headache. |
| 60 | 2021-01-07 | joint pain |
Joint PAIN -upon awakening the next day I had severe neck and bilateral hip pain. It hurt to hold my...
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Joint PAIN -upon awakening the next day I had severe neck and bilateral hip pain. It hurt to hold my head up and even lay on a pillow. Took 800mg Advil prn for about 4 days. Tonsillitis- Right tonsil was inflamed and sore . This started 5 days after the vaccine and lasted 3 -4 days. Used warm water rinses and gargled with Listerine As I am a Nurse with Rheumatoid arthritis , I know there is not much info about subjects with my underlying conditions . I just wanted to report that it did cause a flare in my symptoms but it lasted less than a week. I did hold my Humira for one week after the vaccine as I know it is a "t-cell " inhibitor and I wanted a good result from the vaccine. I had my second shot today and can update you as to how things go
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| 60 | 2021-01-08 | joint pain, muscle pain |
17 hours after vaccine, developed gradually worsening fatigue, myalgias, arthralgias, chills, sweats...
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17 hours after vaccine, developed gradually worsening fatigue, myalgias, arthralgias, chills, sweats, malaise, and fever up to 103. Sxs peaked at approx 24 hrs post vaccine administration, resolving nearly completely by the following morning. Would have reported via v-safe but had no info to access the app.
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| 60 | 2021-01-08 | joint pain |
Severe fatigue, headache, joint pain, fever. Started around 0700 next day of injection and these sym...
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Severe fatigue, headache, joint pain, fever. Started around 0700 next day of injection and these symptoms lasted 24 hours. Took Tylenol, Ibuprofen for fever. Even with these two onboard, continued low grade temp.
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| 60 | 2021-01-08 | joint pain | Arthralgia chills, swollen glands, fatigue x 2 days; |
| 60 | 2021-01-09 | muscle pain, bone pain |
Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improve...
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Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improved with Meloxicam. The keratitis flared up. Developed keratitis after the first dose on 12/17/2020. Lot EK5730. The keratitis presented with dry eyes, photophobia and reduced reading ability. I am treated with steroid drops and artificial tears.
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| 60 | 2021-01-10 | joint pain, muscular weakness |
Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and ...
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Muscle and joint weakness with chest muscle pain x 5 days hurts all over and worse when gets up and moves. Diarrhea started 1-5-2021. No fever 97.7. Off work for 4 days. Using heating pad and inhalers. Has appointment with provider 1-5-2021 and 1-7-2021. Test for COVID on 1-7-2021 and negative Symptoms resolved 1-9-2021 and returned to work on 1-11-2021
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| 60 | 2021-01-10 | joint pain |
COVID vaccine #2 given Thursday January7th 12:30. Body aches and chills started Friday January 8th ...
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COVID vaccine #2 given Thursday January7th 12:30. Body aches and chills started Friday January 8th approx. 1700. Worsening symptoms through the night. Fever and slight cough on Saturday morning with body aches, joint pain and chills.
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| 60 | 2021-01-10 | armpit pain, neck pain |
She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion ...
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She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion and when wearing a mask. Aching in left arm, in chest and in right arm pit. Very dry eyes and bloodshot. Sweating and very warm. Temperature 1-11-21 96.2°F
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| 60 | 2021-01-10 | muscle pain, joint pain | nausea,weakness,chills , fever , muscle and joint pain , no appetite |
| 60 | 2021-01-10 | neck pain, joint pain |
dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nau...
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dizziness around 8:00pm, fatigue, severe headache, neck & shoulder pain, body aches, joint pain, nauseous, mild shortness of breath
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| 60 | 2021-01-11 | joint pain |
Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point;...
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Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: K5730, via an unspecified route of administration from 29Dec2020 16:15 at a SINGLE DOSE for covid-19 immunization. Medical history included migraine with aura. Concomitant medication included gabapentin, pravastatin, estradiol, diphenhydramine hydrochloride (ALLERGY), and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took amoxicillin and had allergies. On 30Dec2020 15:00, the patient experienced pain at injection site, tiredness, chills, joint pain, fever and felt paralyzed at one point. The outcome of events was recovering. No follow-up attempts possible. No further information expected.
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| 60 | 2021-01-11 | limb discomfort |
Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat an...
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Dizzy Clammy Heavy legs Frequent PVC on monitor Irregular heartbeats Headache Tightness in throat and chest
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| 60 | 2021-01-11 | muscle pain |
developed more severe arm pain, headache, rigors, muscle aches- lasted approx 3 -4 hour- took tyleno...
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developed more severe arm pain, headache, rigors, muscle aches- lasted approx 3 -4 hour- took tylenol, used heating pad
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| 60 | 2021-01-12 | back pain, joint pain |
achy knees/ achy joints/ achy right elbow; Headache; her temperature was 96, but not a fever; Achy b...
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achy knees/ achy joints/ achy right elbow; Headache; her temperature was 96, but not a fever; Achy back; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162B2 (Batch/lot number: EJ1685, Pfizer product), via an unspecified route of administration in in left arm on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was receiving concomitant therapy. The patient previous received first dose of BNT162B2 on 08Dec2020 and experienced left arm a little sore at the injection site. The patient experienced achy knees/ achy joints/ achy right elbow, headache, her temperature was 96, but not a fever, achy back, all on 07Jan2021. She got her 2nd vaccine (COVID-19 Vaccine) on 06Jan2021 and this morning, the longer the morning goes on, she felt achy, has a headache, feels like she has a fever but does not. Had temperature taken this morning going into work and it was 93. Just now, her temperature was 96, but not a fever. She stated that this was nothing major, but the information she received said to call and report anything. First temperature taken this morning was from a forehead thermometer. The type of thermometer used for her second temperature this morning was not provided. She was a secretary for environmental services at the hospital she works at. She stated that she thought she could go to work and had to leave. She was going to bed as soon as she hangs up. Height: she used to be 5 feet 8 inches. She was counting on feeling better by tomorrow. She further described her achy feeling as her joints are achy including her knees, back and her elbow, but only her right elbow. She received the injection in her left arm. All she wanted to do now, was to crawl into a warm bed. She stated that she was fine after the first shot. Her arm was a little sore and that was it. She had her first COVID-19 Vaccine injection in her left arm. The soreness at the injection site lasted 2 days and then recovered completely. She did not provide her concomitant medications, stating that she took the same medications that she usually took and had not started anything new. She stated that she was 60 and has the what she had, but she did not have anything of concern; further stating that she had no breathing difficulties or anything like that. The patient underwent lab tests and procedures which included body height: 172.72 cm, body temperature: 93, body temperature: 96, all on an unspecified date. The outcome of events was not resolved.
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| 60 | 2021-01-12 | muscle pain |
At 4hrs post vaccination experienced extreme muscular pain between shoulder blades. The following we...
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At 4hrs post vaccination experienced extreme muscular pain between shoulder blades. The following week, as far as I can recall, I began to have tingling from the right shoulder blade down to my hand. I thought I may have a pinched nerve and went to the walk in clinic to be seen by the nurse practitioner that is in the same office as my primary. She examined me and thought it sounded like a pinched nerve and said I was swollen in the area of complaint. Cervical and thoracic x rays were taken (normal) and was told to take Flexeril and steroids. Pain was getting worse and primary told me to begin taking Meloxicam and have physical therapy. I have been doing both beginning 1-11-2021. Pain continues with no improvement. Do not know if my symptoms are caused from the Covid shot, but just seemed to me that it was quite a coincidence that muscle pain began on the same day as receiving the shot.
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| 60 | 2021-01-14 | joint pain, neck pain |
left neck moderate to severe pain; pain started radiating down her left arm and down left leg; weake...
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left neck moderate to severe pain; pain started radiating down her left arm and down left leg; weakening her joints on those extremities/ shoulder pain; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EK5730, expiry date: unknown), via an unspecified route of administration, on 16Dec220, at a single dose on arm right for COVID-19 immunization. Medical history included diabetes mellitus 2, hypertension (HTN), migraines, back pains, hypothyroidism, and allergies to latex and kiwi. The patient received the vaccine at a military base. She did not receive other vaccines in four weeks. The patient was not pregnant at the time of vaccination. She had no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included unspecified medications; she received other medications in two weeks. The patient previously took gabapentin and topiramate (TOPAMAX), in which she experienced allergies. On the second day after receiving the vaccine, 18Dec2020 04:00 AM, the patient started feeling left neck moderate to severe pain, and the pain started radiating down her left arm and down left leg, weakening her joints on those extremities. This continued severely for 3 days. At this time, she continued to feel mild left neck, shoulder and arm pain intermittently. She could not report this immediately due to not having her vaccine documents which she forgot at her workplace as she proceeded to vacation. She had paused in getting the second dose that was due on 07Jan2021, waiting to hear from Pfizer. The patient received NSAIDS and Muscle relaxant medications as treatment for the reported adverse events. Outcome of the events was recovering.
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| 60 | 2021-01-14 | limb discomfort |
1/13/21 had pain in R arm and employee woke up 1/14 with cramping, chest pain and feeling of heavine...
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1/13/21 had pain in R arm and employee woke up 1/14 with cramping, chest pain and feeling of heaviness from belly button down to the legs. Advised to go to the EC for evaluation. Update 1/15: Seen in ED and had EKG with inverted T wave. Still has heaviness in legs. Will get a referral to cardiology after speaking with PCP.
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| 60 | 2021-01-14 | muscle pain, joint pain | Fever 38.8 Chills Muscle and joint pain |
| 60 | 2021-01-14 | muscle pain |
Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus,...
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Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.
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| 60 | 2021-01-14 | muscle pain |
Patient reports chills, fever, muscle aches, headache, 100.1 within 24 hours. Also report loss of ap...
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Patient reports chills, fever, muscle aches, headache, 100.1 within 24 hours. Also report loss of appetite, fatigue.
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| 60 | 2021-01-14 | neck pain |
Received dose 1 of Pfizer Covid vaccine on 12/22/20, reported she noticed small bump on the side of ...
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Received dose 1 of Pfizer Covid vaccine on 12/22/20, reported she noticed small bump on the side of her neck the next day or so. No systemic symptoms. Did not seek treatment/evaluation. Received second dose (lot EK9231) on 1/13/21 and reports that the bump is tender and has gotten bigger.
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| 60 | 2021-01-15 | joint pain | Arm and joint pain, itching, rash |
| 60 | 2021-01-16 | joint pain |
1) I sat for 30 minutes after shot since I have a mild shellfish allergy. When I stood up, I was br...
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1) I sat for 30 minutes after shot since I have a mild shellfish allergy. When I stood up, I was briefly dizzy but only for a few seconds at most. 2) By the time I reached my car, I had developed a mild headache which lasted until around noon the next day. The headache was not severe. 3) Shoulder that received the shot was sore for about two days.
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| 60 | 2021-01-16 | bone pain, joint pain |
Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: ...
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Initial symtom of warm flush (head to toe), followed by added symtoms over course of next 5-10 min: light headed, dizziness, pale, tachycardia, scratchy throat, heaviness in chest, tightness in throat, spike in blood pressure (initial 144/88, 168/96, 152/87, 146/84-final). Monitored symptoms 45 min to one hour. Temp 97.3. Symtoms lasted approx one hour, then began improving, with exception of light headedness and general malaise and fatigue for 4 hrs. Additional event at approx 10 hours post vaccine: excruciating upper arm pain (left shoulder to elbow), felt "down to the bone". Unable to move arm and very painful to touch. Took 600 mg ibuprofen. Severe pain lasted approximately 3-4 hours (unable to sleep). Then became moderate soreness at injection site x 8 hrs. Mild soreness x 12 hrs, no pain 36 hrs after vaccine. Continued fatigue and malaise for 3-4 days after vaccine.
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| 60 | 2021-01-17 | muscle pain |
limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her bo...
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limping one side of foot; wanted to pass out; numbness to right side of face; every muscle in her body hurts; stomach is cramping; This is a spontaneous report from a contactable consumer. A 60-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140) , via an unspecified route of administration on 04Jan2021 at the first single dose at Arm Left for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. The patient experienced wanted to pass out, numbness to right side of face, every muscle in her body hurts, stomach is cramping on 08Jan2021, limping one side of foot on 11Jan2021. The outcome of event wanted to pass out was unknown; outcome of event numbness to right side of face, stomach is cramping, limping one side of foot was not recovered; outcome of event every muscle in her body hurts was recovering;
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| 60 | 2021-01-18 | back pain |
6PM DAY OF SHOT ITCHING IN EXTREMITIES LOWER LEGS AND ARMS JUST ABOVE WRIST. PAINFUL LOWER BACK PAIN...
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6PM DAY OF SHOT ITCHING IN EXTREMITIES LOWER LEGS AND ARMS JUST ABOVE WRIST. PAINFUL LOWER BACK PAIN. TOOK TWO BENEDRYL AND SYMPTOMS RESOLVED BY AM. 1/16 HAD SYMPTOMS OF AN ON-COMING COLD, SLIGHT SORE THROUGH, SINUS PRESSURE AND FELT WARM. NO TREATMENT OTHER THAN FLUIDS AND REST AND RESOLVED BY MORNING. 1/17 AND 1/18 ONLY SYMPTOM MILD FATIGUE
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| 60 | 2021-01-20 | joint pain, muscle pain, neck pain | Sore arm vomiting diarrhea muscle pain pain in the neck to the shoulders |
| 60 | 2021-01-20 | joint pain |
received 2nd dose at 7pm 1/18/21. woke up tuesday with sore arm went to work and while working after...
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received 2nd dose at 7pm 1/18/21. woke up tuesday with sore arm went to work and while working afternoon progressed to chills and total body aches. temp 101 through evening up and down after motrin to next day Wednesday. wednesday had some chills but during night into Thursday had joint pain no fever. woken up thursday with joint pain and headache no fever.
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| 60 | 2021-01-20 | facial discomfort, muscle pain |
Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up i...
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Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up in nose felt weird and dry like menthol. Put ice on face. Took Tramadol. Having fatigue. Next day felt better, then started having brain fog difficulty remembering, vision is blurry, no energy and feel exhausted.
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| 60 | 2021-01-20 | muscle pain |
chills; fatigue; deep muscle aching in both arms; fever ranged between 100-101 F; This is a spontane...
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chills; fatigue; deep muscle aching in both arms; fever ranged between 100-101 F; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration at left arm on 08Jan2021 at 09:30 at single dose for COVID-19 immunization. The patient medical history included seasonal allergy from an unknown date and unknown if ongoing and COVID-19 from Oct2020 (as reported: "I had been diagnosed with COVID-19 on 21Oct2020 with symptoms onset on 15Oct2020") to an unknown date. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY), aspirin, calcium/cholecalciferol (CALCIUM + D3), docusate. The patient previously took COMPAZINE and BACTRIM DS and experienced allergies. The patient reported that on 08Jan2021 at 21:00 developed chills, fatigue, deep muscle aching in both arms and fever ranged between 100- 101 F. On 09Jan2021 at 09:00 he felt fine, until approximately 17:00 and again developed chills, muscle aching and fatigue. On 10Jan2021 at 08:30 all symptoms were gone and never returned. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 21Oct2020. The patient outcome of the events was recovered on 10Jan2021 at 08:30.
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| 60 | 2021-01-21 | back pain, neck pain, joint pain |
right deltoid pain, fatigue, headache, neck pain, low back pain, right axillary lymph node swollen/d...
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right deltoid pain, fatigue, headache, neck pain, low back pain, right axillary lymph node swollen/discomfort
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| 60 | 2021-01-21 | back pain |
INJECTION 1===back ache, heat from waist down to top of knees, no fever INJECTION 2===rash on top of...
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INJECTION 1===back ache, heat from waist down to top of knees, no fever INJECTION 2===rash on top of both legs- no fever
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| 60 | 2021-01-24 | muscular weakness, back pain, joint pain |
Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate...
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Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 60 | 2021-01-24 | muscular weakness | Severe fatigue, muscle weakness and chills |
| 60 | 2021-01-25 | muscular weakness |
The patient experienced syncope within 30 minutes after receiving the covid-19 vaccine. At 2:30pm, s...
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The patient experienced syncope within 30 minutes after receiving the covid-19 vaccine. At 2:30pm, she felt dizziness, her head was spinning, weakness of the arms, and slurred speech. Her FS was at 108 (Normal), BP 195/105 (Extremely high), Pulse 91, O2 saturation was at 100%. At 2:48PM, her BP lowered to 167/92. At this time, she can smile, she can put her hands up, she can kick her feet and she can opened/closed her eyes. Due to her high BP, Doctor requested that the should go to the ER via the ambulance.
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| 60 | 2021-01-25 | muscular weakness |
Syncope,dizziness, head spinning,weakness of arms slurred speech BP 195/105 PULSE 91 Repeat BP 167/...
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Syncope,dizziness, head spinning,weakness of arms slurred speech BP 195/105 PULSE 91 Repeat BP 167/92
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| 60 | 2021-01-25 | muscle pain |
Slight fever, 99.2, with chills and muscle aches. Event occurred about 2:00 am on 01/26/2021. I took...
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Slight fever, 99.2, with chills and muscle aches. Event occurred about 2:00 am on 01/26/2021. I took a Tylenol went back to bed. No fever upon waking. Minor muscle aches and mild soreness at injection site.
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| 60 | 2021-01-25 | neck pain, muscle pain |
Very swollen and erythematous arm; Very swollen and erythematous arm; chills; severe neck pain; myal...
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Very swollen and erythematous arm; Very swollen and erythematous arm; chills; severe neck pain; myalgias; This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient (not pregnant) received first dose of bnt162b2 (Lot number: Ek5730), via an unspecified route of administration in left arm on 22Dec2020 11:30 at single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing (COVID prior vaccination: Yes). There were no concomitant medications. The patient experienced very swollen and erythematous arm, chills, severe neck pain, myalgias, all on 22Dec2020 14:00. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment given. The outcome of events was resolved. Facility type vaccine: Hospital. No other vaccine in four weeks. No other medications in two weeks. No COVID tested post vaccination. Not known allergies or other medical history.
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| 60 | 2021-01-25 | neck pain |
Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizz...
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Left arm very painful, pain in my neck left side goes into my chest and back of head left side, dizziness, and horrible fatigue. Feeling out of it.
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| 60 | 2021-01-26 | joint pain |
First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and ...
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First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.
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| 60 | 2021-01-26 | muscle pain |
C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccin...
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C/o muscle aches, calf cramps, (B) feet numbness, cough, nausea, diarrhea, all began after #2 vaccine. No problems with #1 vaccine Tx antiemetic, H2 blocker, anti histamine, Tylenol push fluids
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| 60 | 2021-01-27 | joint pain |
Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritat...
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Severe Left Leg, Hip and Lower left leg pain (Sciatic Nerve) it appears the vaccine may have irritated sciatic nerve pain. Left left leg numbness. Decreased mobility, difficulty sitting, walking, and even lying in bed. Started very quickly without andy known injury. Pain continued to worsen. Pain even worse after second injection. Now two weeks after second shot, the pain is going away. It is like the nerve irritation is subsiding. The way the irritation is subsiding makes it seem that the vaccination may have caused irritation to the nerve. After receiving 1st and continuing through the second vaccine, started having severe sciatica pain going down left hip and leg. Left leg pain and numbness. Thought I had done something to damage the nerve. Hurt to sit, hurt to stand and even hurt when in bed. The pain was so severe it caused issues with any mobility. Took Advil, Aspiring, Tylenol and nothing helped. Received second vaccine 1/12/2021 the pain continued and even got worse. It was to the point I couldn't even walk. I couldn't figure out how I had damaged the nerve. I am now thinking it was from the vaccine. I believe the vaccine irritated the nerve. The nerve pain is starting to go away. Normally if you have a sciatic nerve issue, it just doesn't go away on its own. I know there have been reports of severe back and neck pain. I believe it can irritate the nerves which cause severe pain. I wanted this reported in cases others complain of similar issues. The good thing it is improving.
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| 60 | 2021-01-27 | armpit pain, neck pain |
Had normal site pain, fatigue and began running fever of about 100.0 the evening of injection howeve...
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Had normal site pain, fatigue and began running fever of about 100.0 the evening of injection however the fever has continued x7 days, getting as high as 101.9. I began noticing soreness in the lymph nodes in my neck and underarms on the evening of 1/25 and that lasted until midmorning of 1/27.
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| 60 | 2021-01-27 | muscle pain |
Muscle pain; Chills; Nausea; This is a spontaneous report from a contactable consumer. A 60-year-old...
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Muscle pain; Chills; Nausea; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left upper arm on 11Jan2021 around 3:45-4:00pm at a single dose for COVID-19 vaccination. Medical history included hypothyroidism. Concomitant medication included levothyroxine from 2006 for hypothyroidism. The patient was administered the first dose of Pfizer-BioNTech COVID Vaccine on 11Jan2021 at work. On 12Jan2021, the patient experienced muscle pain, chills, nausea. The outcome of the events was not recovered. The patient underwent rapid COVID-19 nasal swab test and the result was negative on 12Jan2021. Second dose scheduled to be administered on 01Feb2021 with no dose change made. Information on the Lot/batch number has been requested.
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| 60 | 2021-01-28 | joint pain, muscle pain |
Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneo...
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Headache; chills; shaking; weakness; tiredness; nausea; Joint pain; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:15 (at the age of 60-years-old) at a single dose for COVID-19 immunization. Medical history included arthritis (knees), sulfa drugs allergy, poison ivy allergy (severe), and COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and furosemide (LASIX). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain on 16Jan2021 at 13:00. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 nasal swab: negative (test name: Binex) on 12Jan2021 and COVID-19 test: unknown results (post vaccination) on an unspecified date. Therapeutic measures were taken as a result of the events, which included naproxen sodium (ALEVE); it was reported that the treatment did not work. The clinical outcome of headache, chills, shaking, weakness, tiredness, nausea, joint pain, and muscle pain was unknown. The batch/lot number for the vaccine, BNT162B2, was provided and has been requested during follow up.
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| 60 | 2021-01-28 | joint pain | 101 fever, body aches, headache, joint aches |
| 60 | 2021-01-28 | armpit pain |
Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain ...
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Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain Headache
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| 60 | 2021-01-28 | armpit pain |
FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT C...
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FLU LIKE SYMPTOMS STARTED 3AM 1/29/2021 WITH GENERALIZED BODYACHE, LEFT AXILLARY PAIN, TENDER LEFT CERVICAL NODES, HOT AND COLD FLASHES AND HEADACHE. NASAL CONGESTION.
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| 60 | 2021-01-31 | muscular weakness |
6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days...
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6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.
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| 60 | 2021-02-01 | joint pain, bone pain |
headache, joint & bone pain, red lump at injection site, injection site warm to the touch, soreness ...
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headache, joint & bone pain, red lump at injection site, injection site warm to the touch, soreness at injection site, some wheezing 40 x 40 mm
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| 60 | 2021-02-01 | bone pain |
Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On ...
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Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones. I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29. There was the normal injection site soreness on the evening of the first day.
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| 60 | 2021-02-01 | muscle pain |
Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, s...
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Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.
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| 60 | 2021-02-03 | joint pain |
Right upper arm/shoulder pain, including pain within joint. Limitations to move arm and weakness co...
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Right upper arm/shoulder pain, including pain within joint. Limitations to move arm and weakness continue even after 1 month.
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| 60 | 2021-02-03 | muscle pain |
Starting about 30 minutes after the injection she had nausea and occasional dizziness. About 12 hour...
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Starting about 30 minutes after the injection she had nausea and occasional dizziness. About 12 hours later she began having fever, chills and muscle aches. Fever improved with Motrin.
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| 60 | 2021-02-03 | muscle pain |
I had covid Sept 26th 2020.The day after the second shot I had covid symptoms. Seven days later I st...
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I had covid Sept 26th 2020.The day after the second shot I had covid symptoms. Seven days later I still have chills,fever,muscle aches and fatigue. I am going for a covid test today.I have missed days of work due to this vaccine.
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| 60 | 2021-02-04 | joint pain |
12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache o...
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12 hours after shot, all over body aches, sore arm and shoulder, fever. Shortly after, a headache occurred. The symptoms lasted all day and were mostly gone except for a small headache and fuzzy brain after 30 hours. All clear after about 36 hours.
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| 60 | 2021-02-04 | muscle pain |
Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache w...
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Radiating pain the first night in the arm and in the muscle behind her breast. Continual head ache with fatigue and sore throat swollen glands since the vaccine in the evenings.
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| 60 | 2021-02-07 | limb discomfort |
12/22 Vaccination 4 hours later, chest pain. Felt heavy. Got extremely sleepy. I tried to lay down,...
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12/22 Vaccination 4 hours later, chest pain. Felt heavy. Got extremely sleepy. I tried to lay down, episode of syncope. Chest discomfort. ER for observation
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| 60 | 2021-02-07 | muscle pain |
injection site pain; chills; muscle aches; fatigue; Rash on torso, arms; This is a spontaneous repor...
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injection site pain; chills; muscle aches; fatigue; Rash on torso, arms; This is a spontaneous report from a non-contactable other hcp (patient). A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 14:30 at single dose in Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history was none. Concomitant drug received within 2 weeks of vaccination included Multivitamin. The patient previously received first dose of BNT162B2 on 29Dec2020 03:15 PM at single dose in Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 6 hrs on 19Jan2021 21:00 PM, the patient experienced injection site pain. After 12 hrs the patient experienced chills, muscle aches, fatigue in Jan2021. The patient experienced Rash on torso, arms 36 hours after in Jan2021. The outcome was Recovering. No treatment received for events. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible, information about batch number cannot be obtained.
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| 60 | 2021-02-07 | muscle pain |
Had a very mild case of COVID in November. Slight muscle tenderness for 1 day after first shot. Ha...
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Had a very mild case of COVID in November. Slight muscle tenderness for 1 day after first shot. Have had same symptoms as COVID but much worse after 2nd shot. Symptoms started Day 4 after vaccine and continue today. Running fever for 5 days now. Still sick. Flu test was negative although I doubted it was anything else since I rarely get sick and when I do it only lasts a day or two. Will have a few hours where I finally think I am getting better and then another wave hits.
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| 60 | 2021-02-07 | muscle pain |
Swollen glands; severe headache; muscle pain; extremely tired; body hurts; This is a spontaneous rep...
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Swollen glands; severe headache; muscle pain; extremely tired; body hurts; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number El3248/expiration date: unknown), via unknown route of administration, on 09Jan2021 12:30 PM (at the age of 60 years old) as a single dose on left arm for COVID-19 immunisation for COVID-19 immunisation at a Public Health Clinic/Veterans Administration facility. Relevant medical history included breast cancer last year. The patient had no allergies to medications, food or other products. Relevant concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient experienced swollen glands, severe headache, muscle pain, extremely tired, body hurts on 14Jan2021. The outcome of the events swollen glands, severe headache, muscle pain, extremely tired, body hurts was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.
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| 60 | 2021-02-08 | armpit pain |
her face got swollen; lymph node right there it was extremely swollen and very tender and very painf...
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her face got swollen; lymph node right there it was extremely swollen and very tender and very painful; She had a lump at the site of the injection; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine , via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation . Medical history included hypertension. Concomitant medication included telmisartan (MICARDIS). On 30Dec2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced her face got swollen on an unspecified date with outcome of unknown , lymph node right there it was extremely swollen and very tender and very painful on an unspecified date with outcome of unknown , she had a lump at the site of the injection on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , flu like symptoms on an unspecified date with outcome of unknown. The events swollen face and lymph adenopathy were considered important medical Events. The remaining events were considered non serious. The patient stated she got the second vaccine shot of Pfizer on Wednesday the 20Jan2021. She got like a weird side effect like under her armpit it got really swollen and painful, like the lymph node right there it was extremely swollen and very tender and very painful. It still is but not as much. The next day the right side of her face was swollen The patient received Tylenol as treatment for the events. Follow up information has been requested.
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| 60 | 2021-02-08 | joint swelling, joint pain |
left upper arm redness and swelling. She reports she got the second Pfizer COVID-19 vaccine on Mond...
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left upper arm redness and swelling. She reports she got the second Pfizer COVID-19 vaccine on Monday 2/1. She reports the area is red right after the vaccine. She reports she has had increased swelling, redness, warmth. She reports she did have reaction to her first vaccine with redness and swelling, but that occurred 10 days after. She reports she has had some fever and body aches that she associates with having the second vaccine. Constitutional: Negative for chills and fever. HENT: Negative for sore throat. Eyes: Negative for visual disturbance. Respiratory: Negative for cough and shortness of breath. Cardiovascular: Negative for chest pain. Gastrointestinal: Negative for abdominal pain, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Positive for joint swelling and arthralgias. Negative for back pain. Skin: Positive for color change. Negative for rash. Neurological: Negative for weakness and numbness.
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| 60 | 2021-02-09 | joint pain, weight decreased |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous re...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at arm right on 20Jan2021 at 10:00 at single dose for COVID-19 immunization. The patient medical history included diabetes from an unknown date and ongoing. The patient's concomitant medication included metformin. The patient experienced COVID-19 on 27Jan2021 (she got all the symptoms: sinus, headache, body aches, pain, chills, joint pain, fever). The patient was admitted to emergency room due to the event. The patient underwent lab test and procedure which included blood test and chest X-ray both on an unspecified date and both resulted that "everything was good" values not provided, in Jan2021 body weight: between 114-115 lbs, but probably 110 (lost a lot of weight in the past two weeks because of the virus) and SARS-CoV-2 test (nasal swab): positive on 27Jan2021. Therapeutic measures were taken as result of COVID-19 and included treatment with benzonatate (lot: 7893614, dose: 100 mg; one pill a day), ivermectin (dose: 3 mg, 4 pills a day for 2 days, exp: 28Apr2021), prednisone (dose: 20 mg, 3 tablets once daily lot: 7893618 ), azithromycin (dose: 500 mg, for five days, lot: 7893308). Medications she was prescribed in the emergency room were helping a little bit. The patient outcome of the events was unknown.
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| 60 | 2021-02-10 | joint pain |
Severe chills; joint pain; This is a spontaneous report from a contactable other healthcare professi...
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Severe chills; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old female patient received bnt162b2, via an unspecified route of administration on 30Jan2021 at 04:45, single dose in the Left arm for covid-19 immunization. Medical history included Hashimotos Thyroiditis. Concomitant medication included thyroid (ARMOUR THYROID). The patient previously took Levoquine and experienced allergies. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. In Feb2021, the patient experienced severe chills and joint pain still 4 days later. The patient did not receive treatment for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 60 | 2021-02-10 | muscle pain |
on 2/6/2021 woke up in am with headache, chills, temperature . Symptoms continued with chills, sweat...
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on 2/6/2021 woke up in am with headache, chills, temperature . Symptoms continued with chills, sweating, lethargic with muscle aches and pains along with temp. Temperature returned to normal in pm on 2/7/2021. Muscle aches and pains, itchy at injection site and being tired lasted another couple of days. Feeling back to normal by 2/10/2021
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| 60 | 2021-02-10 | neck pain |
Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the ne...
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Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the neck. Then my arm pit was swollen, hot and the swelling went down my arm. I also had diarrhea, Nausea, slight head ache, chills, body ache with a temp of 101.5. Went to the doctor yesterday because of my armpit swelling, hot to touch and it had a red band. She said where they gave it was not in a muscle. It was given sub Q & that it went into my lymph gland and leaked down my arm to swell. Right now I just have on and off nausea , pain in my lymph glands in my arm pit. The swelling and pain has gone down and the other symptoms have faded away.
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| 60 | 2021-02-11 | arthritis | started having arthritis |
| 60 | 2021-02-14 | joint pain, muscular weakness |
About 12:30 AM on 2/14/21, I woke with extreme chills, muscle weakness, possible fever and sweats, j...
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About 12:30 AM on 2/14/21, I woke with extreme chills, muscle weakness, possible fever and sweats, joint pains. About 2:30 AM, I took two 325 MG aspirin. About 9:30 AM, I woke again with the same extreme symptoms listed above. I took an additional two 325 MG aspirin. About 4 PM, my symptoms were not as severe, but I was still unable to engage in daily activities, and I took an additional two 325 MG aspirin. Symptoms continued, but lessened, and about 9 PM, I told an additional two 325 MG aspirin and a zolpedim CR to help me sleep throughout the night. I woke about 6:45 AM on 2/15/21, with mild muscle weakness, joint pain, and feeling slow and tired. As of this report at 11:15 AM on 2/15/21, I am functioning at about 80% capacity, some chills and muscle/joint pain.
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| 60 | 2021-02-14 | joint pain, muscle pain |
Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbea...
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Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbeat with severe pressure and chest pain. Ongoing muscle and joint pain that moves from location to location. Redness on chest and facial - cheeks.
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| 60 | 2021-02-15 | joint pain |
Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , head...
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Day 4 sudden feeling unwell, out of it, severe burning pain throughout whole body, joint pain , headache, cough, fatigue, upset stomach, diarrhea. Subsided in about 36 hours.
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| 60 | 2021-02-17 | joint pain, back pain |
This is a spontaneous report from a contactable consumer. A 60-year-old female patient started to re...
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This is a spontaneous report from a contactable consumer. A 60-year-old female patient started to receive bnt162b2 (manufacturer unspecified), lot number: EL4238, via an unspecified route of administration in the left arm, on 21Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included arthritis. Patient's known allergies are Penicillin, Peanut and Dairy. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There were no concomitant medications. The patient's whole/entire arm was killing her; she was hurting across her shoulder blades down to fingers. Her elbow and wrist were hot and she was feeling a tremble in hand which she has never had before. She later added that her joint in elbow and shoulder was now reaching down to her arm. She couldn't even wear her watch today to her work, it felt swollen, like there was liquid in it. She also can't lift her arm, move and the pain was like going into her back. The patient was taking Aleve and Advil and "it doesn't take away all but it takes away enough that she can function." She also bought a topical ointment to help numb the area and she was wearing a pain patch on my back. The outcome of events was reported as 'not recovered'. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
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| 60 | 2021-02-17 | joint pain, muscle pain | Fever 101, Muscle and Joint aching, tired. Lymph node swollen in left armpit |
| 60 | 2021-02-17 | back pain, joint pain |
lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded...
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lightheaded to the point of nearly passing out; nausea; general feeling of being unwell; lightheaded to the point of nearly passing out; cold sweat; loss of appetite; pain in upper shoulder/back area; pain in upper shoulder/back area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL-9265), via an unspecified route of administration on 29Jan2021 12:30 in left arm, at single dose for covid-19 immunization. Medical history included chronic low BP, hypothyroidism, HRT, nasal allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), multivitamin NOS (MULTIVITAMIN). The patient previously took amoxicillin; clavulanic acid (AUGMENTIN) and known allergies: Augmentin, being treated for nasal allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, general feeling of being unwell, lightheaded to the point of nearly passing out; cold sweat, loss of appetite, pain in upper shoulder/back area, on 01Feb2021 06:30. No treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.
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| 60 | 2021-02-17 | muscle pain, joint pain |
This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female pat...
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This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3247) intramuscular in right arm on 01Feb2021 at 11:30 am (at 60 years) at single dose for covid-19 immunisation . Medical history included hypertension (HTN) , hypergammaglobulinaemia benign monoclonal (MGUS) , mononucleosis (recent mononucleosis one year before). Patient was not pregnant. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), hydrochlorothiazide/ losartan potassium (HYZAAR), amfepramone hydrochloride (TENUATE). The patient previously took IV dramamine, tetanus and ceclor and experienced allergy. Previously, on 18Jan2021 at 10:30 am (at 60 years) she took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3248) intramuscular in right arm for covid-19 immunisation. Patient took the 1st dose of the vaccine on 18Jan2021 and 2nd dose on 01Feb2021 (inappropriate schedule of vaccine administered). Events were described as follows: next day, on 02Feb2021 at 06:00 temperature of 100.6, arthralgias and myalgias, dizziness. Second day (Feb2021), temp lower but still around 99.8 (normal for her 97.2), vasovagal, dizziness, arthralgias and myalgias. Events were non serious. Patient (a nurse) treated herself with dramamine for the dizziness, Nyquil and Advil. The final outcome of pyrexia, vasovagal, dizziness, arthralgias and myalgias was recovering.
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| 60 | 2021-02-20 | joint pain |
Left shoulder has periodic pain and stinging as if someone with a heavy hand is giving me an injecti...
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Left shoulder has periodic pain and stinging as if someone with a heavy hand is giving me an injection now. The pain wakes me up at night. Sometimes in the day I feel the pain level at about a 6.
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| 60 | 2021-02-20 | back pain |
2-19-21 by 8pm full body aches and head ache 2-20-19 12am woke to severe chilling and temp 101.3, ...
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2-19-21 by 8pm full body aches and head ache 2-20-19 12am woke to severe chilling and temp 101.3, 6am temp 100.8, 5pm temp 99.9, 9:30 pm temp 99.7, slept the whole day with continual aches and pains in legs, arms, and back, with a severe headache 2-21-21 6:30am temperature 97.6, improvement in aches, headache gone, slight ache in legs, arms and back, walking better, feel like getting up and doing something
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| 60 | 2021-02-23 | musculoskeletal discomfort |
I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's pos...
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I only had 1 dose on 2/16/2021 and got the reaction 1 week later 2/23/2021.. Not sure if that's possible but wanted to report it anyway. body ache, joint discomfort, migraine headache all day, fever, chills & nausea - this started about 10am on 2/23/2021 and lasted until 2am the following morning 2/24/2021. I took 600 mg of motrin every 6 hrs and 600 mg of tylenol every 4 hrs. I feel fine today
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| 60 | 2021-02-24 | limb discomfort |
As per Dr: 60 year old woman with history of MVA and back pain presents to office today with left ar...
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As per Dr: 60 year old woman with history of MVA and back pain presents to office today with left arm pain and discomfort that started three weeks ago and has resolved but left her with tingling sensation in her third, fourth, and fifth digits on her left hand, symptoms started three weeks ago, hours after getting her COVID-19 vaccine. About a week and a half ago she began feeling numbness of her right leg going up to her upper abdomen with progressively worsening symptoms that have stabilized in the past several days. She also feels that her walking is off but cannot quite describe how or when it started. Exam notable for left-sided cervical myelopathy and decreased sensation on her right side up to a mid-thoracic sensory level. Of note she has a first cousin on her fathers side with multiple sclerosis and a more distant cousin on her mother's side with multiple sclerosis. Father with Parkinson's disease. I see that COVID-19 biofire came back positive. In light of this, COVID myelopathy is on the differential
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| 60 | 2021-02-25 | joint pain | third day, fatique, headache, aching joints |
| 60 | 2021-02-25 | musculoskeletal stiffness |
Strong metallic taste in my mouth about 5-10 min after vaccination (lasted about 45 min); morning st...
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Strong metallic taste in my mouth about 5-10 min after vaccination (lasted about 45 min); morning stiff shoulders and back of neck (still have it but it's better); This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration on 26Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included PVCs (Premature ventricular contractions), coronary artery disease (CAD) and allergies to NSAIDS, artificial sweeteners, sulfa, and mango. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included nicotinic acid (NIASPAN), vitamin d nos, metoprolol tartrate (LOPRESSOR), omega-3-acid ethyl ester (LOVAZA) and Nexlizet. No any other vaccines received within 4 weeks prior to the COVID vaccine. On 26Jan2021 12:45, the patient experienced strong metallic taste in her mouth about 5-10 min after vaccination and morning stiff shoulders and back of neck (still have it but it's better). No treatment was received for the events. The patient has not been tested for COVID-19 since the vaccination. The patient was recovering from the events.
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| 60 | 2021-02-26 | joint pain | Fever 101.1, aching joints, shortness of breath that I still have week later, loss of taste, |
| 60 | 2021-02-26 | muscle pain |
IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatig...
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IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness Headache Fatigue brief chills LATER & NEXT DAY Pain left arm Muscile aches, especially legs Brief episode of nausea Slight fever
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| 60 | 2021-02-27 | joint pain |
That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches...
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That evening starting to feel flu like symptoms. Today I feel like I have the stomach flu-body aches, headache, sore arm, nausea, 102 fever, joint pain
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| 60 | 2021-02-27 | limb discomfort |
My upper arm started feeling odd ... numbness in my left upper arm. I liken the feeling to when I?m ...
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My upper arm started feeling odd ... numbness in my left upper arm. I liken the feeling to when I?m having dental work done and my mouth/lips are numb. Through the night I developed some aching in my left shoulder. No treatment. Just an annoying feeling of not being able to feel my upper arm. It feels cold as well.
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| 60 | 2021-02-28 | arthritis |
Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level ...
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Pfizer. My right hand was swollen up like a catchers- mit. Very painful in thumb joint at a level 10. Was swollen for 5 days, then fever chills, body aches (fever 0f 100.2) Right hand was so painful was intolerable, truly had to wait for it to pass, nothing helped except for soaking in Epsom salt bath, which was short live. Have had arthritis in this thumb but not for approximately 8 years. Entire hand was swollen and not useable.
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| 60 | 2021-02-28 | armpit pain |
Swollen and very sore lymph glands in left armpit/chest with pain/tenderness on the underside of arm...
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Swollen and very sore lymph glands in left armpit/chest with pain/tenderness on the underside of arm where injection was given; ice was used to reduce swelling and was alternated with heating pad. soaked in warm bath with epsom salts. relief was finally achieved by taking 1 Aleve liquid gel capsule - 220 mg. Swelling and pain began within 24 hrs after injection and pain increased intensely by hour 36. Some tenderness to touch still in lymph glands in armpit/chest and to underside of arm. minimal tenderness at actual injection site - no more than normal for a injection.
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| 60 | 2021-02-28 | muscle pain | Fainting Extreme muscle aches |
| 60 | 2021-02-28 | neck pain |
pain in lymphoma area; pain in lymphoma area; Multiple headaches; neck pain; inner ear pressure; jaw...
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pain in lymphoma area; pain in lymphoma area; Multiple headaches; neck pain; inner ear pressure; jaw pain; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included type 2 diabetes and overweight, and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included lisinopril, metformin, metoprolol, sitagliptin (JANUVIA). The patient did not receive any other vaccine within 4 weeks of the vaccination. On 01Feb2021 at 09:00, the patient experienced multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcomes of multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain was resolving.
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| 60 | 2021-03-01 | joint pain |
Vaccine given 2/9/21. On the afternoon of 2/12/21 I began to have joint pains in my right wrist. By ...
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Vaccine given 2/9/21. On the afternoon of 2/12/21 I began to have joint pains in my right wrist. By 2/10/21 in the morning both elbows, knees and wrists were sore. Elbows and right knee felt warm to the touch. Nodules or red spots developed around the joints. I could barely walk or climb in and out of the car, the bed, and had a very difficult time standing up from the toilet or a low chair or couch. No fever, but did have a few chills with teeth chattering at least twice.
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| 60 | 2021-03-01 | muscle pain, joint pain |
Seizure: Sunday 2/28 @noon Migraines: 2/28 post seizure & 3/1 & 3/2 Pre-seizure symptoms: 3/1 & 3/2 ...
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Seizure: Sunday 2/28 @noon Migraines: 2/28 post seizure & 3/1 & 3/2 Pre-seizure symptoms: 3/1 & 3/2 ExtremeMuscle&Joint pain, fatigue, Ubrelvy 100mg 2/28 & 3/2, Ibuprofen 800mg, alt w/Tylenol 2-500mg, Rest/sleep most of days, warm showers, heating pads
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| 60 | 2021-03-02 | joint pain, arthritis | Debilitating Joint Pain so much that she can't walk. Generalized inflammation. |
| 60 | 2021-03-02 | muscular weakness |
Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appet...
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Elevated blood pressure, headache (2 days), fever, EXTREME chills/shaking, congestion, loss of appetite, fatigue, could not lift arm.
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| 60 | 2021-03-03 | joint pain |
SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSE...
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SORE ARM, VERY TIRED, SEVERE HEADACHE, SORE MUSCLES ALL OVER, CHILLS, KNEE AND HIP JOINT PAIN, NAUSEA, SWOLLEN LYMPH NODES UNDER BOTH ARMS, FEELING UNWELL
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| 60 | 2021-03-03 | muscle pain |
At midnight after the shot I developed 99.9, chills, myalgia, severe migraine and all of it lasted 1...
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At midnight after the shot I developed 99.9, chills, myalgia, severe migraine and all of it lasted 16 hours. I reported it to the nurse practitioner but did not want to see her because I knew it would resolve. I am a nurse and expected it would improve on it's own and it did. I did take Tylenol for the symptoms when they began. I work in a clinic.
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| 60 | 2021-03-04 | joint swelling |
4 hours after vaccine, had the following Reaction : -Big Chills -Nausea -Small amount of swelling o...
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4 hours after vaccine, had the following Reaction : -Big Chills -Nausea -Small amount of swelling on Face, Ankles, & Wrists -Very tired = fatigue / sleep
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| 60 | 2021-03-04 | musculoskeletal discomfort, facial discomfort |
Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on m...
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Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on me, I immediately tasted something weird in my mouth. It was not as metallic tasting as usual. More plasticy. Shot did not hurt. Was told to stay in 30 minutes waiting area.I did. The taste remained in my mouth. I left at 10:34 am feeling OK, except for weird taste. As I drove off the parking lot, I noticed that my mouth and tongue were tingling, with worst of it on my left side. My throat did not seem to be affected, so I continued driving. Some nasal congestion and coughing. The tingling turned into numbness in my mouth and tongue, all the way back to top of throat. I called my primary care doctor at 12:10 pm and left a message. I received a call back at 2:15 pm from nurse. She told me to take Benadryl and have someone take me to Urgent Care right away to get my vitals checked. I did not take Benadryl, as CDC said it could mask anaphylactic reaction. I called a friend and she took me . I noticed that my lymph nodes in my neck were swelling and painful. We arrived at 2:45 pm. My vitals were checked, heart and breathing listened to and was checked briefly for swelling in mouth and throat. There was no swelling. He said he had never heard of this tingling reaction and claimed it is just a side effect and not a serious reaction and that it would probably last a couple of days. He recommended that I watch for new symptoms and take Benadryl. That was $30. We left at 3:10. We left. I noticed that the numbness was spreading to my lips and up the left side of face and I was getting super tired. Also, my mid to lower back started hurting a lot. I took a Benadryl. 4:30 pm still have same numbness. My eyes got super dry and itchy. My head started to hurt. Some coughing. 5:10 pm dry eye and numbness, more swollen lymph nodes and chills. Pain in calves, upper back, same on both sides. 6:38 weirdly, from the bottom of my thumb to halfway up my arm there is pain. Both arms simultaneously. Worse on the left. 8:11 pm after bundling up and using a heating pad, plus extra heat, chills are lessened. Lymph nodes very sore in neck. Eyes are not quite as dry. Everything else is the same. 8:48 pm jaw really aches. Intestinal discomfort. Going to bed. 10:39 pm pain from jaw extended up into left ear. Upper part of throat hurts. March 5, 2021 4:00 am. Body aches have lessened. Left arm sore at shot area. 5:45 am eyes definitely dry, but not nearly as dry as yesterday. Numbness in mouth , tongue and face has lessened, but still uncomfortably present. Definitely worse on the left side. Little bit of tingling on the left, mostly on cheek from chin to ear. Headache gone. Lymph nodes sore and swollen . 7:00 am went on a walk. Noticed some achyness throughout body. Very tired. 10:51 am The tingling and numbness remain in my mouth, tongue and cheek up to my left eye. Very tired. Lymph nodes still swollen and sore.
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| 60 | 2021-03-04 | musculoskeletal stiffness |
Red, itchy, bumpy, swollen rash on right shoulder extending to right breast. Swelling of left hand...
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Red, itchy, bumpy, swollen rash on right shoulder extending to right breast. Swelling of left hand, stiffness, hard to move fingers, same rash as above between fingers.
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| 60 | 2021-03-06 | joint pain, neck pain |
Starting about one hour after the injection, my left shoulder began to hurt a little bit. As the d...
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Starting about one hour after the injection, my left shoulder began to hurt a little bit. As the day progressed the pain increased substantially into my shoulder. It then started to hurt on the left side of my neck. I took Tylenol before bed, 500 mg is all I can take. This pain kept me awake all night and this morning I am not able to lift my arm up or down or sideways without pain, quite a bit of pain. Today is Sunday and I do not plan to seek medical care unless it continues to worsen. I will probably talk with my medical provider tomorrow if this continues.
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| 60 | 2021-03-07 | neck pain, joint pain |
Almost immediate discomfort at injection site, followed by sore shoulder (left) and neck pain as wel...
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Almost immediate discomfort at injection site, followed by sore shoulder (left) and neck pain as well as headache for 24 hours. One week later, severe joint pain for 48 hours.
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| 60 | 2021-03-07 | weight decreased |
Since the week after the first Pfizer vaccine, I began struggling with symptoms of diabetes. I exper...
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Since the week after the first Pfizer vaccine, I began struggling with symptoms of diabetes. I experienced extreme thirst, frequent urination and I lost 17 pounds in the 3 weeks following the first dose. I never associated it with the vaccine, initially, because I never heard of any side effects like increased glucose, and my dad and sister have type 2 diabetes, so I was altering my diet, but the symptoms did not subside. I proceeded to get the second vaccine and that?s when I knew something was seriously wrong. That afternoon my blood sugar was 528, my vision was blurred, and I experienced a strange feeling in my heart. I was diagnosed by my GP with diabetes, and put on medication (Metformin and Glipizide). I proceeded to see an endocrinologist, I was put on insulin and after additional blood tests was diagnosed with Latent Autoimmune Diabetes , and Premature Atrial Complexes.
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| 60 | 2021-03-08 | joint pain, muscle pain |
Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hur...
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Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hurt, weak, mild consistent headache, nausea, skin sensitivity, feeling like a bad case of the flu for 30 hours. Getting better by Sunday evening. Still not 100% as of Tuesday. Slight headache comes and goes like a sinus infection would feel like.
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| 60 | 2021-03-08 | armpit pain |
Sore nipples and armpits for several days then today light vaginal bleeding I am in or done with me...
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Sore nipples and armpits for several days then today light vaginal bleeding I am in or done with menopause and have not had a period for several years
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| 60 | 2021-03-08 | back pain | fever, chills, back pain, fatigue, loss of appetite, foggy |
| 60 | 2021-03-09 | back pain |
On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3...
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On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin. Went to doctor and had MRI done. Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active. The back is now ok after rest and physical therapy but the insomnia still persist.
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| 60 | 2021-03-10 | armpit pain |
My Arm Pit and my Breast on my right side of my body became so painful as if I had a major injury or...
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My Arm Pit and my Breast on my right side of my body became so painful as if I had a major injury or surgery. Tylenol and Aspirin could not control the intense pain. The pain was excruciating!! I also had aches, fever, chills and tender lymph nodes in my neck. The excruciating pain last 3-4 days. 7 days later I still have tenderness in my breast and arm pit.
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| 60 | 2021-03-10 | joint swelling | Joints swollen and moderate fatigue Feels like a Lupus flare |
| 60 | 2021-03-11 | joint pain |
Approximately 10 hours after the vaccine, I awoke with pain in all the joints in my body. I took Ibu...
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Approximately 10 hours after the vaccine, I awoke with pain in all the joints in my body. I took Ibuprofen and went back to sleep. When I woke up later I felt better but was tired and achy for the next 24 hours. I continued taking Ibuprofen So adverse event lasted approximately 48 hours
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| 60 | 2021-03-13 | joint pain, muscle pain |
INJ. PAIN 3/11/2021 TIREDNESS 3/12 &13/2021 HEADACHE 3/11 & 12/ 2021 MUSCLE PAIN 3/11 & 12/2021 C...
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INJ. PAIN 3/11/2021 TIREDNESS 3/12 &13/2021 HEADACHE 3/11 & 12/ 2021 MUSCLE PAIN 3/11 & 12/2021 CHILLS 3/12 & 13/2021 JOINT PAIN 3/11/12/13/2021 FEVER 3/12/13/2021 102.5 & 100.2 FEELING UNWELL 3/12/13/2021 I JUST KEPT TAKING TYLENOL TILL I FELT BETTER. I AM FINE TODAY. 3/14/2021
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| 60 | 2021-03-13 | armpit pain |
2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:...
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2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache
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| 60 | 2021-03-13 | musculoskeletal stiffness, back pain, joint pain |
My tongue swelled slightly and the right side of it became numb. This lasted for 30 minutes. If it...
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My tongue swelled slightly and the right side of it became numb. This lasted for 30 minutes. If it had gotten worse I would have gone to a hospital but it went away. Also, starting around 8 PM on Thursday and lasting until Saturday evening, my hips and lower back were extremely stiff and achy.
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| 60 | 2021-03-14 | armpit pain | Pain in my left armpit and left breast area |
| 60 | 2021-03-14 | back pain, armpit pain |
Fever, nausea, whole body aches, pain in arm, armpit, back, chest, dizziness, palpitations, headache...
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Fever, nausea, whole body aches, pain in arm, armpit, back, chest, dizziness, palpitations, headache.
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| 60 | 2021-03-14 | back pain |
Normal side effects except extreme pain at back and left kidney. Felt like I had been kicked in the ...
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Normal side effects except extreme pain at back and left kidney. Felt like I had been kicked in the kidney by a mule. Lasted Wednesday through Friday. Could not get comfortable.
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| 60 | 2021-03-16 | joint pain, back pain |
A few days after the vaccine on that Wednesday I began having pain in the upper shoulder and back ar...
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A few days after the vaccine on that Wednesday I began having pain in the upper shoulder and back area which persisted to a heaviness in my chest going into Thursday. Thursday night I woke up in the middle of the night to the feeling of not being able to breathe. I laid awake for a while but dosed back off and it happened again a little later. It felt as if someone was sitting on my chest which prompted me to go to the ER the next day. Various test were done and I was admitted in the hospital for further observation. After admission I developed a massive headache which lasted from that Friday afternoon until that Sunday. I was released on that Sat and the symptoms seemed to be getting better and by that Sunday evening all symptoms had subsided.
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| 60 | 2021-03-16 | musculoskeletal stiffness |
As I pulled up for the 15 minute wait period the symptoms started 5 minutes after I received my vacc...
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As I pulled up for the 15 minute wait period the symptoms started 5 minutes after I received my vaccine. A tingling feeling up my left arm to back of my neck. My neck stiffened and then my throat started to close. Not to where I can't swallow but just like when I eat food that I'm allergic too, it closes up. The nurse that was overseeing me was holding the umbrella over my car window with the rainfall. All of a sudden their was lightning & thunder. The nurse threw the umbrella because she was shocked from the lightning. She started to talk to all the other around her and forgot about me. Since I could still swallow I didn't get her attention. When she returned she asked me the time so I had to pull my phone out. She didn't know the time of my 15 minutes and sent me away. As soon as I got out of the parking area but still inside amusement park, I started to feel my cheeks becoming numb and my right eye was blurry. I quickly moved over to the side lane still inside of amusement park and waited. I called my husband and told him that with the heavy rain I didn't feel safe driving with my right eye being blurry. I waiting another 15 minutes before driving home. That evening the blurriness came back, my eye's & forehead was tender to touch but no headache. Only pressure in my head. My symptoms of closed throat, swollen cheeks, pressure in my head and blurriness continued on Friday, March 12th, Saturday, March 13th, Sunday, March 14th and Monday, March 15th. As of today, no other systems other than feeling my body has inflammation.
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| 60 | 2021-03-17 | muscular weakness | numbness, pain and weakness to lower extremities. |
| 60 | 2021-03-17 | neck pain, limb discomfort |
Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness ...
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Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness and soreness in arms; Heaviness and soreness in arms; has a sore spot only where the COVID vaccine was; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN9581), via an unspecified route of administration on 04Feb2021 at 10:20 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included ongoing multiple sclerosis. There were no concomitant medications. The patient previously received the first dose bnt162b2 (Lot: EL3249) on 14Jan2021 for COVID-19 immunisation and experienced couldn't re stand. The patient experienced could stand, couldn't walk on 05Feb2021, frontal headache, heaviness and soreness in arms on 04Feb2021, swollen lymph nodes in left arm on 05Feb2021, neck ache on 04Feb2021 at 22:00, had a sore spot only where the covid vaccine was in Feb2021. Event details: The patient had the second COVID vaccine on 04Feb2021. Was fine that day. Had heaviness in her arm and little bit of headache. Was fine the day of the shot. 04Feb2021, felt a little heavy in the arm where she got the COVID shot. Received COVID vaccine in left arm. Drove home and was fine. Sat down and watched TV and had a frontal headache. Took Tylenol. By the time she went to bed, around 10:00 PM, her neck was so sore to turn from side to side. On top of her arms where shoulder pads would be is there the heaviness was. Both arms became sore. It was manageable and she took Tylenol. Eventually it went away. Friday morning 05Feb2021 when she got up, got to the point where she got out of bed and couldn't get up. There was no possible way for her to get up. Her husband had to buy her a 3-in-1 potty chair so she could just stand and pivot, seriousness was provided as disabling, could understand hospitalization, but confirmed she never went to the hospital. Could not rest that day or go back to the bathroom. Didn't walk anywhere. Was in a chair that she could sleep in. Husband bought her a potty chair. Was able to use the lift on the lift chair later that afternoon. Definitely debilitating. Sister who was an orthopedist nurse had to help her and secured she wouldn't fall. The patient had swollen lymph nodes only in the left arm on 05Feb2021. At time of reporting the patient had a sore spot only where the COVID vaccine was. It was not red. Only sure up underneath and when it was touched. The outcome of events could stand, couldn't walk, heaviness and soreness in arms was resolved on 06Feb2021, outcome of other events was unknown.; Sender's Comments: Based on available information, due to close temporal association, a possible contribution roe of bnt162b2 to the onset of "unable to walk" cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-03-18 | musculoskeletal chest pain |
I started throwing up and had diarrhea by around 10 pm, did that about 4 times, my stomach was so bl...
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I started throwing up and had diarrhea by around 10 pm, did that about 4 times, my stomach was so bloated, it was weird. The next day, couldn?t get out of bed, all I had yesterday was diarrhea and felt like someone kicked me in the ribs. Today I am having a hard time taking a deep breathe or coughing without my ribs hurting so bad. My stomach feels better. Haven?t eaten anything, I am more concerned about under my breast hurt so much when I take a deep breathe or cough. I haven?t gone to doctor because I just wonder if it hurts so much there because if the vomiting
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| 60 | 2021-03-19 | joint pain | Headache, injection site pain, nausea, tiredness, joint pain |
| 60 | 2021-03-20 | joint pain |
Severe joint pain to knees and hands lasting now into 3-4 weeks. Knee pain now gone, hand/joint pain...
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Severe joint pain to knees and hands lasting now into 3-4 weeks. Knee pain now gone, hand/joint pain remains. I think the hand/joint pain may be getting better?
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| 60 | 2021-03-20 | joint pain | Chills, itching, swelling of lips, itchy eyes, sore joints, |
| 60 | 2021-03-20 | muscle fatigue |
Muscle fatigue was noticed around 5pm, took a 500mg Tylenol and laid down. Went to sleep. Muscle f...
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Muscle fatigue was noticed around 5pm, took a 500mg Tylenol and laid down. Went to sleep. Muscle fatigue continued throughout the night and into next day (FR 3/19/21), continued to take 500mg Tylenol every 6 hours, slept through Noon on Friday, felt better laying down throughout rest of Friday/Friday night. Symptoms gone about 2:30am SA 3/20/21
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| 60 | 2021-03-20 | musculoskeletal stiffness |
I felt fine when I woke up. My left arm was very sore which also was the case after first vaccine. A...
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I felt fine when I woke up. My left arm was very sore which also was the case after first vaccine. Around 10 am I developed chills and just did not feel great. My husband took my temp and the highest it got was 102.6 which is high for me since my baseline is 97.6 or so. I did not have a great appetite and felt very stiff when I moved around. I pushed fluids and took 3 naps Saturday. I have a low grade fever of 99 today but feel much better. Did take 2 naps and slept well last night. Took Advil with each meal and doing so today.
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| 60 | 2021-03-21 | joint pain, back pain |
I called My primary care doctor on Thursday afternoon the 14th to see what they thought. They said...
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I called My primary care doctor on Thursday afternoon the 14th to see what they thought. They said I should go to ER. I called my Psychiatrist and his Nurse said call my regular primary care doctor. Since then I?ve been icing my back, knees, ankles and shoulders.. I?ve been taking ibuprofen and acetaminophen- Alternately . Resting but the pain only subsided for a few minutes
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| 60 | 2021-03-21 | joint pain, joint swelling |
Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, for...
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Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg; Oral ulcer; Chill; Body ache; Joint pain; Joints swelling; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201), via unspecified route of administration in the left arm on 17Feb2021 as single dose for COVID-19 immunization. Medical history included hyperlipidemia. The patient had no known allergies. The patient is not pregnant. There were no vaccine in four weeks. Other medications in two weeks included cholesterol med. The previously received the first dose of BNT162B2 on 26Jan2021 12:00 intramuscular at left arm (lot number: EL9262) for COVID-19 immunization. The patient was seen at urgent care on 04Mar2021 due to 4 days progressive worsened skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg from 28Feb2021 (12:00 AM). Patient presented with chill, body ache, joint pain, joints swelling and diarrhea since second dose of vaccine on 17Feb2021. She also has oral ulcer at the same time when rash started on 28Feb2021. Vital sign was stable, no shortness of breath (SOB) and no chest pain. Events resulted in Doctor or other HCP office/clinic visit. The treatment for the events included Hydroxyzine 25 mg prn. It was unknown if patient had COVID prior vaccination or if COVID tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Erythema multiforme cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 60 | 2021-03-21 | joint pain, muscle pain, neck pain |
8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscl...
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8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.
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| 60 | 2021-03-21 | joint pain, muscle pain |
extreme fatigue, headache, nausea, muscle aches, joint pain, low grade fever, chills, swollen lymph ...
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extreme fatigue, headache, nausea, muscle aches, joint pain, low grade fever, chills, swollen lymph nodes in neck and under arm, treatment was motrin 600 mgs q6hrs from 2/18/21-02/22/21 returned to work on 02/23 lymph nodes still slightly enlarged as of today, 03/22/21
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| 60 | 2021-03-21 | joint pain |
By eight pm my left arm started hurting. At 2:30 am Sunday morning it was hurting so bad it woke me ...
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By eight pm my left arm started hurting. At 2:30 am Sunday morning it was hurting so bad it woke me up. I could not raise my arm up past 6 inches. My left arm and side down to my waist was hurting. I took some Ibruprofen. Used a heating pad on my shoulder. Finally got back to sleep for a few hours. When I woke around 7:30 am, most of the pain had moved under my arm and to the front of my shoulder. I sat in my hot tub (100 degrees) for an hour and took more Ibruprofen. I was able to raise my arm up about half way. Was very tired. Went back to bed around 10 am and slept until 2:30. Had a headache and fatigue. Napped off and on the rest of the day. Today I can raise my arm all the way up, slowly. It is still painful to do so. The headache and fatigue are minimal.
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| 60 | 2021-03-21 | musculoskeletal pain | Chills, musculoskeletal pain, headache, sinus pain, nausea, tooth sensitivity |
| 60 | 2021-03-21 | neck pain | pain from vaccine site up back of neck, tingling lips and glassy eyes |
| 60 | 2021-03-22 | muscle pain |
Started out with mild muscle pain with certain movement. Effects ability to drive and work. Saw Dr o...
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Started out with mild muscle pain with certain movement. Effects ability to drive and work. Saw Dr on 3/16/2021 Steroid cream, tylenol, and Xrays done. Informed that they might need to do an MRI. At this time she does not feel like it is getting any better. Sometimes hurts more than other times depending on activity, feels heavy and week. Can feel it poping and grinding with movement.
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| 60 | 2021-03-22 | neck pain |
At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fing...
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At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.
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| 60 | 2021-03-23 | joint pain, muscle pain |
I was submitting my events daily on website and two days it tells me my session has expired and won'...
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I was submitting my events daily on website and two days it tells me my session has expired and won't let me report anything. On Sunday night, March 21st, I started with very painful joint and muscle aches with fatigue. The next morning I felt terrible and could barely function, I had a bought with diarrhea that lasted almost the entire day and had no energy. I developed a large lump on my left clavicle area that seemed to be filled with fluid. My knees I had replaced are still very painful today ( 7 days post vaccine). I phoned my Dr. yesterday and they told me to take 1000mg of Tylenol 3 times a day. I am doing this now for the second day with some relief. I feel this is very unusual to feel this way 7 days after the vaccine. On day 1-2 the only symptoms were a sore arm from the vaccine. Saturday was actually a good day with no symptoms, the other symptoms started on Sunday. I feel like my heartbeat is irregular also but my BP is good. I would like to be able to to report daily on v-safe like I was the first few days.
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| 60 | 2021-03-23 | joint pain |
Received the first vac on 3/12 at 8:30 a.m.. I started feeling achy and tired by 4pm. By the next da...
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Received the first vac on 3/12 at 8:30 a.m.. I started feeling achy and tired by 4pm. By the next day, I had diarrhea and stomach upset starting by mid day. Since then, I have had daily diarrhea, lethargy, weakness, off and on headache, body aches (especially joints) and overall feeling of unwell.
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| 60 | 2021-03-23 | joint pain |
Swollen lymph nodes under the arms, joint pain throughout but highly concentrated on the right side ...
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Swollen lymph nodes under the arms, joint pain throughout but highly concentrated on the right side of body and arm
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| 60 | 2021-03-23 | back pain |
After I left the facility, driving home I notice that my back was starting to hurt, so I turned on t...
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After I left the facility, driving home I notice that my back was starting to hurt, so I turned on the heat on my back . When I got home, I had difficulty getting out of my car. I sat in a chair and within the next few minutes I was not able to stand. My husband had to come help me get up and stand, there was pain across my lower back like pin needles and up part of my spine. I took Motrin and it helped it subside somewhat not much. The second day it continued but later started to ease a little but I was not able to walk upright. Third day, 3/24, it is starting to ease up and I am able to walk upright, there is still discomfort. I have contacted my physician to report the issue.
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| 60 | 2021-03-23 | muscle pain |
Extreme exhaustion, chills, muscle aches, brain fogginess, headache - all the symptoms I experienced...
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Extreme exhaustion, chills, muscle aches, brain fogginess, headache - all the symptoms I experienced when I had COVID-19 in early November 2020. All symptoms improved within 18 hours except headache, which lasted for 36 hours. Headache was also a lingering effect after all other COVID-19 symptoms subsided when I had the virus, as well.
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| 60 | 2021-03-24 | joint pain, muscle pain, musculoskeletal chest pain, bone pain, musculoskeletal stiffness, back pain |
Day 1 muscle stiffness lower back and slight fever, tired. Day 2 bone, muscle pain moved to right hi...
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Day 1 muscle stiffness lower back and slight fever, tired. Day 2 bone, muscle pain moved to right hip, sore to touch, tired. Day 3 bone, muscle pain moved upper back, tired. Took aspirin. Day 4 bone, muscle pain more extreme, tired. Took aspirin. Day 5 extreme pain in hip and ribs, sore to touch hard to breath, fainted, tired. Took tylenol. Pain went away
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| 60 | 2021-03-24 | bone pain |
neurothopy for 1-2 days; bone pain; Exhaustion; This is a spontaneous report from a contactable cons...
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neurothopy for 1-2 days; bone pain; Exhaustion; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via unspecified route of administration on unspecified date at age of 60 years old at single dose for COVID-19 immunisation. Patient had chemotherapy for ovarian cancer in 2020. Concomitant medications were not reported. Patient experienced exhaustion, bone pain, neurothopy for 1-2 days post first vaccine. Event took place after use of product. Outcome of events was unknown. Information on the lot/batch number has been requested.
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| 60 | 2021-03-24 | limb discomfort |
this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400m...
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this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400mg ibuprofen before going to bed around 11pm. by 1 am on 3/24 I was running a fever, shivering & my inj arm was very sore/felt heavy. Took 400 more ibuprofen, fever reduced before too long. Also felt slightly nauseous during the night & into the day of 3/24. around 2 pm got a bad headache. more ibuprofen, still felt a little nauceous, tho that subsided in early a.m. 3/25. Also was coughing quite q bit most of 3/24, but that may have been due to allergy stuff. experienced some mild diarrhea on 2 occassions 3/24. Symptoms are fairly well abated by 10a.m. 3/25.
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| 60 | 2021-03-25 | joint pain | Severe headache, debilitating joint pain throughout body. |
| 60 | 2021-03-25 | musculoskeletal stiffness | Nausea, Vomit/Diarrhea, Chills (very cold head to toes), body/joints ache, stiff throat |
| 60 | 2021-03-25 | muscle pain |
Approximately 28 hours after administered: extreme fatigue, mild chills and muscle aches. Chills su...
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Approximately 28 hours after administered: extreme fatigue, mild chills and muscle aches. Chills subsided in 4 hours, muscle aches in 6 hours.
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| 60 | 2021-03-26 | joint pain |
On 3/18 Started out with arm and shoulder feeling hot. Then Excruciating pain in shoulder and all d...
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On 3/18 Started out with arm and shoulder feeling hot. Then Excruciating pain in shoulder and all down the arm from 3/19 and still continuing today 3/27. Took Tylenol and used ice on shoulder and arm. Had a massage and stretching done on 3/23 didn?t help much. Contacted my doctors office on 3/23 and have an appointment for 3/31. The symptoms I?m feeling is that of SIRVA. Went to urgent care on 3/26 and was told that ?that is a symptom of the vaccine, give it another day?. Told them it was over a week and the pain I?m feeling is nerve pain. I was told there was nothing they can do for me there. Still feeling the pain today. Still icing and using Voltaren gel to help with inflammation.
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| 60 | 2021-03-26 | muscular weakness |
Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip complete...
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Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip completely white that lasted about 10 min. Once color returned I soon became dizzy and weak feeling in my legs followed with vomiting. I then felt a little better with mild light headedness.
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| 60 | 2021-03-27 | joint pain | painful arm and shoulder, also bump at injection site arose and is itchy |
| 60 | 2021-03-27 | limb discomfort |
1. Some Swelling and redness at injection site 2. Some lymph node swelling and discomfort under righ...
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1. Some Swelling and redness at injection site 2. Some lymph node swelling and discomfort under right arm Outcome not known yet, swelling and redness seem to be lessoning.
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| 60 | 2021-03-27 | muscle pain, musculoskeletal stiffness | Body/muscle pain and stiffness, headache, chills |
| 60 | 2021-03-27 | muscle pain | Headache muscle pain tiredness nausea chills Overall not feeling well |
| 60 | 2021-03-28 | muscle pain |
I have taken Pfizer-BioNTech COVID-19 Vaccine EUA Three days later I have muscle pain, ear infectio...
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I have taken Pfizer-BioNTech COVID-19 Vaccine EUA Three days later I have muscle pain, ear infection, headache, stomach very up set, feeling not well
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| 60 | 2021-03-30 | joint pain, musculoskeletal pain, muscle pain |
Muscles around hip replacement were affected for 2-3 days. Sore muscles in the buttocks, hip and qua...
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Muscles around hip replacement were affected for 2-3 days. Sore muscles in the buttocks, hip and quad. It only affected this site. It went away but I found it odd. I got the usual bit of nausea, wooziness, fatigue and sore arm, but those were expected
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| 60 | 2021-03-30 | back pain |
Pain at injection site, extreme back and body aches, headache, dizziness, low grade fever. Ibuprofen...
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Pain at injection site, extreme back and body aches, headache, dizziness, low grade fever. Ibuprofen & Acetaminophen As of 4:00pm on following day of injection, reactive symptoms still occurring...
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| 60 | 2021-03-30 | muscular weakness, muscle pain |
After typical flu like reaction for 2- 3 days, symptoms of Epstein Barr- extreme exhaustion, muscle ...
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After typical flu like reaction for 2- 3 days, symptoms of Epstein Barr- extreme exhaustion, muscle weakness and aching, swollen glands and headache started about day 5 and have been severe times one month.
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| 60 | 2021-03-30 | musculoskeletal stiffness |
her arm was extremely sore; unable to move left side of neck/unable to move arm; She felt unwell lik...
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her arm was extremely sore; unable to move left side of neck/unable to move arm; She felt unwell like she had the flu/sick; nose running; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), an unspecified route of administration, administered in left arm on 25Feb2021 (at the age of 60-years-old), as single dose for COVID-19 immunisation. Medical history included lupus from 2018 to an unknown date, Cushing's syndrome from 2018 to an unknown date and ongoing Hashimoto's disease. The patient had also allergies. Concomitant medications included ibuprofen (ADVIL). Patient reported that within 2 minutes of getting the vaccine her nose was running. Two hours later she started to feel unwell. Her nose was still running. She was not sure if this was from the vaccine or because of her allergies. She felt unwell like she had the flu. She was sick and progressively getting worst. She was having reaction to the injection. On 26Feb2021 she woke up around 3:00 am and was unable to move the left side of her neck or her left arm. She still has some neck stiffness. She had small incidences for 3 days after. She felt paralyzed. She was unable to move her arm because it was completely painful. She didn't panic that her arm was extremely sore. She was able to move it. Caller added that she though she had Covid when she got the vaccine and didn't know it. She was sent t an EMS station to be tested. She was given the rapid test on 03Mar2021. Within 15 minutes she was told the result was negative. They sent out another test the same day. On 06Mar2021 she received negative results. She was scheduled to get the second dose on 18Mar2021 at 11:00am. The outcome of events 'she felt unwell like she had the flu/sick' was not recovered, nose running was resolving, unable to move left side of neck was resolved on 28Feb2021, unable to move arm was not resolved, the outcome of other event was unknown.
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| 60 | 2021-03-31 | joint pain |
That night felt tired with chills and body aches. The next day I had a fever of 102.2, horrible body...
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That night felt tired with chills and body aches. The next day I had a fever of 102.2, horrible body aches, joint pain, chills, headache, nausea, zero appetite, fatigue. Felt like a bad flu. By Monday the fever was gone but was very weak, nauseous, with joint pain. Didn?t feel like myself for several days-almost a week.
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| 60 | 2021-03-31 | musculoskeletal stiffness | Headache, tiredness, stiff neck, chills, no appetite, slight dizziness, slight buzzing in head |
| 60 | 2021-03-31 | muscle pain |
I had every single side effect listed. Severe headache starting almost immediately, lasting 5 days....
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I had every single side effect listed. Severe headache starting almost immediately, lasting 5 days. Fever of 102, gradually coming down, over 5 days. Severe dry coughing, lasting 6 days and continuing. Severe muscle aches, lasting 6 days so far. Diarrhea lasting 1 day. Nausea, lasting 3 days.
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| 60 | 2021-03-31 | muscle pain |
Headache chills fever upper respiratory cough, muscle aches, earache, stomach ache, pain at inject...
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Headache chills fever upper respiratory cough, muscle aches, earache, stomach ache, pain at injection site and itching
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| 60 | 2021-03-31 | rheumatoid arthritis |
dramatic increase in Rheumatoid Arthritis symptoms; This is a spontaneous report received from a con...
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dramatic increase in Rheumatoid Arthritis symptoms; This is a spontaneous report received from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, in Feb2021 (reported as "last month"), as single dose, for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously took tofacitinib (XELJANZ XR) for rheumatoid arthritis. The patient reported that she missed two weeks of XELJANZ XR last month (Feb2021) due to receiving COVID-19 vaccine. She said she experienced a dramatic increase in rheumatoid arthritis symptoms (unspecified date) as a result of this but she feels like overall Xeljanz XR is managing her rheumatoid arthritis well. The outcome of the event was unknown. No follow-up attempts are possible. Information on lot/number cannot be obtained. No further information is expected.
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| 60 | 2021-04-01 | joint pain |
I was doing my HIIT workout as always (I am 60 and in good physical conditioning) and got bad hip pa...
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I was doing my HIIT workout as always (I am 60 and in good physical conditioning) and got bad hip pain on my left side. I stopped and saw my chiropractor and just took it easy from doing HIIT for awhile.
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| 60 | 2021-04-01 | joint pain | Chills Joint pain Severe fatigue Headache Time course: almost 48 hours |
| 60 | 2021-04-01 | back pain |
The day after the vaccination, there was pain on my left side (my vaccine shot was in my right arm)....
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The day after the vaccination, there was pain on my left side (my vaccine shot was in my right arm). By Saturday 3/27/21 (day 4), a localized rash appeared on my left side (midriff area) which looked like herpes blisters. The area was sensitive to touch and painful. The pain had spread to my left back area. Started 1000 mg Valacyclovir 3 times a day on 3/30/21, after I saw the doctor and she confirmed it was probably shingles. The rash and sensitivity/pain are still present today, 4/2/21, on day 10 after the vaccine.
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| 60 | 2021-04-01 | limb discomfort |
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Ch...
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Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient reported vitals from ER BP=107/70, Liver tests were off due to dehydrated per ER , had fever ,sweats then chills and Headache followed by fatigue for a few days. Patient did notify her PCP
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| 60 | 2021-04-02 | joint pain |
Severe joint pain (shoulders, elbows, hips, knees, ankles); chills; overall body aches. Lasted a lit...
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Severe joint pain (shoulders, elbows, hips, knees, ankles); chills; overall body aches. Lasted a little more than 24 hours, although the severity lessened on the 2nd day. Did not take any medicine to treat symptoms. Resolved by day 3. Enlarged, painful lymph node (right arm pit); lasted 5 days. Dull headache; lasted 3 days.
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| 60 | 2021-04-02 | muscle tightness |
On Saturday, April 3, 2021 clientt received her first dose of Pfizer COVID vaccine (LOT # EW0150, EX...
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On Saturday, April 3, 2021 clientt received her first dose of Pfizer COVID vaccine (LOT # EW0150, EXP 7/2021) at approximately 2:00pm. After vaccine was administered, client was to wait in the Observaton Area for 30 minutes due to Penicillin and sulfa drug allergy. At 2:09pm, client walked up to EMT and stated she was "feeling light-headed." Client was advised to sit in the anti-gravity chair and was given a bottle of water. Upon assessment by EMTs, client's last meal was at 12:30pm. Client also stated to EMTs she felt light-headed right after receiving the vaccine. At 2:13pm, the client stated the back of her neck felt "a little tight" and stated she had a headache. At 2:15pm vitals were taken: BP: 130/76, Hr: 57, RR: 15, O2 sat: 97%. Lead PHN was notified and advised client to be watched for an additional 30 minutes. Vitals at 2:20pm: BP: 128/78, HR: 59, O2 sat: 98%. Vitals at 2:25pm: BP: 128/70, HR: 59, O2 sat: 97%. At approximately 2:40pm, client stated her light-headedness and tightness on the back of her neck completely subsided. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Client was educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client was able to ambulate with EMTs to her car with a steady gait at approximately 3pm.
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| 60 | 2021-04-02 | neck pain |
Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a...
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Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a spontaneous report from a contactable Pharmacist. A 60-years-old female patient received BNT162B2 ( BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247) first dose via an unspecified route of administration, administered in left arm on 18Feb2021 9:15 as single dose for COVID-19 immunization. Vaccination administered facility Workplace clinic. The patient medical history included Osteoporosis; irritable bowl syndrome. The patient concomitant medications included : Citracal; Centrum; Vit D (ergocalciferol); Colace; Evening Primrose (oenothera biennis), ascorbic acid, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, chromium picolinate, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium borate, magnesium oxide, manganese sulfate, nickel sulfate, nicotinamide, panax ginseng root, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium metavanadate, sodium molybdate, sodium selenate, stannous chloride, thiamine mononitrate, tocopheryl acetate, zinc oxide (CENTRUM ENERGY). On 18Feb2021 10:00 patient experienced with sore left arm at injection site (vaccination site pain), tingling feeling on forehead, slight headache, and sore neck on left side. The outcome of the event was recovering. Follow-up information was received on (25-MAR-2021): No new medically significant information was received on this case.
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| 60 | 2021-04-03 | muscle pain |
12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post...
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12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.
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| 60 | 2021-04-04 | joint pain |
Even though taking Tylenol - had fever the next day that became increasingly higher. Highest Fever 1...
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Even though taking Tylenol - had fever the next day that became increasingly higher. Highest Fever 101.5 first day after with bad chills all day, achy joints, dull headache and no energy. Low grade fever 100.5 second day after with Dull headache and low energy.
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| 60 | 2021-04-09 | musculoskeletal chest pain, bone pain |
Sickle cell crisis; She said she was unable to touch her collar bone because of the pain; pain along...
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Sickle cell crisis; She said she was unable to touch her collar bone because of the pain; pain along her heart, collar bone area, and ribs; Hot flash on the left side of her head preceded the headache; Headache; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 12Mar2021 (Batch/Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included sickle cell anaemia diagnosed when she was a baby from an unknown date unknown if ongoing. The patients concomitant medication included unknown injectable medication the patient stated she was given injectable medication for 2 tests, 1 on 23Feb2021 and 1 on 26Feb2021. She said she didn't know the name of the medications given to her and the tests were ordered by her cardiologist. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). The patient experienced sickle cell crisis on 18Mar2021 headache on Mar2021, she said she was unable to touch her collar bone because of the pain on an unspecified date, pain along her heart, collar bone area, and ribs on an unspecified date, hot flash on the left side of her head preceded the headache on an unspecified date. The patient was hospitalized for sickle cell crisis from 19Mar2021 to 20Mar2021. The patient was still had sickle cell crisis pain along her heart, collar bone area, and ribs. She said she was unable to touch her collar bone because of the pain. She said she also had a headache. She clarified the headache started a couple days after she had the COVID-19 Vaccine. She said a hot flash on the left side of her head preceded the headache. She said she still had a headache, and some days her headache was better. She said yesterday (24Mar2021) her headache was so strong. She said the headache was on the left and back side of her head, but particularly strong on the back side of her head. The patient went to the Emergency Room after midnight on 19Mar2021. She said she spent the night at the hospital as an inpatient, and then was discharged by Saturday (20Mar2021) afternoon, around 14:30-15:00. She said she was given Morphine for pain, and was on an IV, and took her regular medicines. She said she did not know the name of the IV fluids that were given to her. The patient underwent lab tests and procedures which included cardiac stress test and electroencephalogram result was unknown. The outcome of event hot flash on the left side of her head preceded the headache was unknown and outcome of all other events was not recovered, Information on the lot/batch number already available. Further information has been requested.
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| 60 | 2021-04-12 | neck pain |
Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional...
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Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Patient said she experienced left side numbness, slurred speech, severe neck pain, and a headache. She said she had stroke like symptoms but after being hospitalized for 3 days and having a CT scan performed stroke was ruled out.
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| 60 | 2021-04-14 | back pain, neck pain |
One week after receiving the first vaccine, I developed severe headaches. I got my booster 21 days l...
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One week after receiving the first vaccine, I developed severe headaches. I got my booster 21 days later. One week after receiving the booster, I started having severe headaches, severe neck, back and abdominal pain. I went to the ED the morning of 3/5/21, was admitted to the hospital and release on 3/8/21. It is in the H&P from Health facility.
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| 60 | 2021-04-14 | muscle pain, joint pain |
I experienced muscle and joint aches, headache and overall malaise. Approximately 14 days after the...
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I experienced muscle and joint aches, headache and overall malaise. Approximately 14 days after the first vaccine , started having vision deficits in my left eye out of the blue. I experienced a fuzziness and haziness in the vision of the left eye and pain above the left eye brow. Was seen urgently in the eye clinic on 3/29/21 and had a battery of tests - a swollen and inflamed left optic nerve was observed and some deficits to vision and peripheral vision. Had second vaccine on 3/31/21 and eye seemed to get worse. Seen by Optical Nerve Specialist on 4/5/21 and had battery of tests and optic nerve worse. Dr. diagnosed as ischemic optical neuropathy likely due to giant cell artritis (GCA). I had urgent/emergent temporal artery biopsy on 4/6/21 to determine if giant cell artritis. Received results from biopsy on 4/13/21 and negative for GCA. Saw Optical Nerve Specialist on 4/14/21 and diagnosed with ischemic optical neuropathy but cause can not be specified. Optic nerve is still swollen and vision impacted. I am to return to clinic in 8 weeks and see if improvement. I have never had any issue like this in the past.
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| 60 | 2021-04-18 | back pain |
appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; enti...
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appendix had ruptured; diagnosed with appendicitis; could barely stand; I felt tired; sore arm; entire intestinal tract and stomach became hard; extended and felt like it was on fire and was extremely painful; vomiting along with diarrhea; vomiting along with diarrhea; pain and burning in my stomach and back; pain and burning in my stomach and back; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 29Mar2021 12:15 (Batch/Lot Number: EP6955) as single dose (at the age of 60-year-old) for COVID-19 immunisation, administered at Pharmacy or Drug Store. Medical history included known allergies: Sulfa drugs, aspirin cordisone. Patient had not COVID prior vaccination. Patient was not pregnant. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, cortisone and experienced drug hypersensitivity. No other vaccine in fourweeks. On 29Mar2021 19:30 the patient experienced she felt tired, sore arm, entire intestinal tract and stomach became hard, extended and felt like it was on fire and was extremely painful, vomiting along with diarrhea, pain and burning in my stomach and back. On 31Mar2021 the patient experienced appendix had ruptured, diagnosed with appendicitis, could barely stand. The patient was hospitalized for appendix had ruptured and diagnosed with appendicitis for 2 days. The events were considered serious as per hospitalization, disability, life threatening. Therapeutic measures were taken as a result of appendix had ruptured and diagnosed with appendicitis: appendectomy. COVID was not tested post vaccination. Course of events was as follows: She had the shot on 29Mar2021 at 12:15, 4 hrs after she felt tired and had sore arm. 7 hours after, her entire intestinal tract and stomach became hard and extended and felt like it was on fire and was extremely painful. 4 hrs later she started vomiting along with diarrhea. The vomiting continued non stop along with the pain and burning in her stomach and back. On 31Mar2021 morning the pain settled into the right lower stomach and became so painful she could barely stand. She went to the ER and was diagnosed with appendicitis. She had surgery that night and found my appendix had ruptured. The OR nurse told he she was the 2nd lady that day who's appendix had ruptured after having their First COVID vaccine and there had been others. She believed this was absolutely the direct result of the vaccine. She queried why were we not warned of this violent side effect of the vaccine. The outcome of events was recovering.
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| 60 | 2021-04-18 | neck pain |
left side headache, left eye pain, severe vomiting, full body pain, neck pain, chills as of Sunday s...
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left side headache, left eye pain, severe vomiting, full body pain, neck pain, chills as of Sunday some had subsided but not all. tylenol of no use!
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| 60 | 2021-04-20 | grip strength decreased |
her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little ...
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her MS started to flare; I have a lot of numbness and tingling in my left side; it's still a little tingling; I have a lot of numbness and tingling in my left side; it's still a little tingling; I had 3 days of sheer misery I couldn't use my left side as I am left handed; it made it kind of difficult; I couldn't hold anything in it, if I wanted to put my hand back; I could not even grab my head up to put it off; I have been not feeling that good; shot I went to home I had gastro intestinal problems; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm left (reported as "Left shoulder") on 31Mar2021, at the age of 60-year-old (Batch/Lot number was not reported, it was reported that "it says Pfizer and then 8733") as single dose for covid-19 immunisation. Medical history included multiple sclerosis (MS) and she had the GA (gallbladder atony) thing it was awful she mean anything she ate or drank, right to the toilet. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop date were not reported and Vitamins. Consumer stated, she had the COVID-19 shot last Wednesday 31Mar2021 and she have MS so what it happens was she have got the shot she went to home she had gastro intestinal problems she had she could not get off the toilet for a while and then her MS started to flare, So she have a lot of numbness and tingling in her left side and it's still a little tingling but she had 3 days of sheer misery. She couldn't use her left side as she was left handed so it made it kind of difficult and she live alone. The reporter wanted to know that it was as potential side effects, she was just glad they didn't go full blown affect because they are miserable. When paraphrased the above concern, Consumer stated, No she was starting to get a lot better because she would be really going to say it if it didn't come, because she was not going to stand it but 3 days she couldn't use it at all, she mean she couldn't hold anything in it, if she wanted to put her hand back and probably feel she could not because she was not she could not hold anything she could not even grab her head up to put it off, as she said she had the GA thing it was awful she mean anything she ate or drank, right to the toilet. Consumer stated, No she haven't talked to anybody like any she have been not feeling that good, the first thing she had blown up in because when she had MS it starts to flare she don't she actually want to do is laid down and sleep. For treatment, consumer stated, no treatment, she stayed home, she just rested that's it, it's like her left side is affected her left leg was affected and her arm is affected all the left side is numb and tingly, so she don't like to do anything she don't like to walk anywhere, it's not good. Consumer stated, she just wanted to let us know in case anyone called us with and MS. Date for second shot of COVID-19 Vaccine is "21Apr2021." The outcome of the event "tingling" was recovering; of the other events was unknown. Information about lot/batch number has been requested.
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| 60 | 2021-04-23 | musculoskeletal stiffness, muscle pain, joint pain |
Severe dizziness, rare front or left headache with pain, pain in both eyes and left eyelid tremor, d...
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Severe dizziness, rare front or left headache with pain, pain in both eyes and left eyelid tremor, diarrhea, muscle and joint pain, stiff fingers, feet and leg muscles, rash all over the body, fatigued and shortness of breath, tiredness.
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| 60 | 2021-04-27 | joint pain, neck pain |
Had prior pain from shoulder blade up to neck and ear. Lasted 3-4 days. Had been increasingly Itchy...
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Had prior pain from shoulder blade up to neck and ear. Lasted 3-4 days. Had been increasingly Itchy. On 4/23/2021, rash on shoulder neck. Went to dr rash not there. Treated for shingles. Rash reappeared later that evening. Husband received vaccine same date/time. Being Treated for shingles. He reported his event
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| 60 | 2021-04-27 | muscle pain | Muscle aches, fever, sleeplessness, fatigue |
| 60 | 2021-04-27 | neck pain |
Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and s...
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Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; Exhaustion; This is a spontaneous report from a contactable other hcp (patient). A 60-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL9262) as SINGLE DOSE in left arm, dose 2 via an unspecified route of administration, administered in Arm Right on 15Feb2021 09:45 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunization. Medical history included arthritis, joint stiffness, back pain, arthralgia and unknown date, Allergic to insect stings. Concomitant medication included acetylsalicylic acid (ASPIRIN); paracetamol (TYLENOL). The patient previously took Augmentin and experienced drug allergy. On 16Feb2021 the patient experienced both times like mini version of covid which patient had a year ago. now right side of my neck hurts and still inflamed, feeling extremely fatigued, headaches, exhaustion (suspected covid-19) The outcome of both times like mini version of covid which I had a year ago, now right side of my neck hurts and still inflamed, feeling extremely fatigued. Headaches, exhaustion was not recovered.; Sender's Comments: The contributory role of the suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL9262) to reported events is probable.
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| 60 | 2021-04-28 | muscular weakness, grip strength decreased |
1/11/2021: Within 40 minutes of receiving 2nd dose Pfizer vaccine, began having tingling bilateral a...
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1/11/2021: Within 40 minutes of receiving 2nd dose Pfizer vaccine, began having tingling bilateral arms proximal & distal. Following day, developed a temperature to 102F which remained x4 days. Since this time, has had continued tingling of the arms & low grade temperature (99F) & has begun having weakness of her upper extremities only with hypersensitivity to heat, as well as touch, but interestingly having decreased sensation to touch of her fingers, feeling as though she wears gloves, with no weakness anywhere else on her body. She has also beginning to develop a sense of decrease cognition. She has been seen by Neurology who felt this was a neurologic hypersensitivity reaction. Initially when she began having complaints following injections/day 1, she was given Benadryl with no improvement beyond causing her to sleep. Since this time she has also been placed on prednisone with no interval improvement. Relates no cutaneous lesions beyond mottling of her arms/no frank urticaria dermatitis etc., and has had no GI complaints or cardiovascular sequela. 4/19/21: This 60 y.o., female is referred by MD for evaluation of bilateral hand pain, weakness and numbness starting shortly after the 2nd dose of her COVID vaccine (5 her). The patient has generally been in excellent health. On Monday, January 11th at 9:20 a.m. she received the 2nd dose of COVID vaccine (Pfizer), in the left deltoid. She had no immediate reaction but while driving about 45 min later developed numbness and tingling bilaterally in her face, lips, tongue and hands. She awakened at about 3:00 a.m. with fever of 102, no abnormal sensations in her face but pain, redness and sensitivity in both hands. Systemic symptoms resolved in several days. Hand symptoms have continued to date. Pain can range as high as 8/10. She has marked sensitivity such that if she or someone else touches her hands it is extremely painful. She sleeps with opera gloves to protect them. She has not had neck pain but has developed grip weakness and has to use 2 hands to hold a cup of coffee. She has never had adverse reactions to vaccines in the past. She has had no immunologic disorders. She initially saw Dr. who tried a short course of steroids without benefit. She took gabapentin 200 mg followed by 100 and slept for hours without a change in the pain. NSAIDs have been ineffective. No other medications have been tried. She has had nothing to suggest a symptomatic COVID infection. 4/23/21: The patient continues to have bilateral hand sensitivity and temperature lability. The EMG showed diffusely slow sensory conductions, consistent with the non correctable low temperature of her hands. Motor conductions were notable for slowing in the right median motor with drop in amplitude proximally but with waveforms that did not suggest conduction block. All motor terminal latencies and F response latencies were normal. Overall the study is probably normal within technical limitations but if necessary should be repeated in about a month with her hands warmer. The nortriptyline was just approved yesterday and the blood tests 2 days ago. She will start the nortriptyline over the weekend and let me know if it is tolerable or effective. She will get the blood work done early next week and I will review the results with her. HISTORY: This patient with bilateral hand dysesthesias and temperature lability following COVID vaccination comes in for neurophysiologic testing. Notably the nortriptyline was just approved and she has not yet started taking it. Similar the blood test were just approved 2 days ago and she will have them drawn next week. Her symptoms have not changed since he was here last.
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| 60 | 2021-04-30 | joint pain, neck pain, back pain |
anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both,...
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anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.
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| 60 | 2021-04-30 | musculoskeletal discomfort, joint swelling |
DVT blood clot; ankle was still swollen and uncomfortable; ankle was still swollen and uncomfortable...
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DVT blood clot; ankle was still swollen and uncomfortable; ankle was still swollen and uncomfortable/discomfort; nights were the worst for the pain; pulse ox was low; d-dimer was very high; fainted; Fracture of ankle/two fractures on her ankle; severely nauseous; Vomiting; Diarrhea; deathly sick; This is a spontaneous report from a contactable consumer, reporting for herself. A 60-year-old female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: ER8727), via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 at a single dose for covid-19 immunisation. Medical history included osteoporosis at least 10 years, terrible nausea, mild case of covid from Nov2020 to an unknown date. There were no concomitant medications. The patient previously took alendronate from 2008 to an unknown date and experienced very sick, nausea, diarrhoea and zoledronic acid (RECLAST) from Dec2017 and experienced nausea and vomiting. On 27Mar2021 at 2:00, the patient experienced deathly sick, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, and diarrhea. On an unknown date, the patient experienced dvt blood clot, ankle was still swollen and uncomfortable/discomfort, the nights are the worst for the pain, pulse ox was low, and d-dimer was very high. The event, deathly sick, was life-threatening. The clinical course was as follows: the patient had the first dose of the vaccine on 26Mar2021 at 14:00 in the afternoon in her left arm. Twelve hours after the first dose, later in the night about 02:00 AM she woke up deathly sick; and severely nauseous. She remembered she was going to the bathroom then she must have fainted because they were taking her to the hospital. She went to the ER and they found she had a fractured ankle. She was not admitted to the hospital. She was in the ER from about 03:00 AM to noon the next day. There must have been something in there; she knew there must be something in the vaccine because of her reaction. Adds a few years ago, something like this happened before. She had osteoporosis and had similar reactions with other products she had tried for osteoporosis; she had terrible nausea. The other products she tried included: in 2008 she took alendronate, it made her very sick but not as severe as this time, she never fainted. She had nausea and diarrhea. Then in Dec2017 she had zoledronic acid. She went for an infusion at the hospital then went shopping, and was fine until the early morning, when she woke up with nausea and vomiting. In the ambulance, they gave her ondasetron (ZOFRAN) for the nausea so the vomiting stopped. With regard to her ankle, first they thought it was a DVT blood clot. They did the xray and saw actually two fractures on her ankle but she does not need surgery. She saw the orthopedic doctor the other day and he said her ankle was healing but she still will have no weight bearing for 6 weeks and she was in a boot. Adds her ankle was still swollen and uncomfortable. She hated to take medications and they gave her oxy but she didn't want to take it. She was taking ibuprofen but that messed up her stomach. The nights are the worst for the pain and discomfort. Doctor at the hospital and primary care agreed she should not have the second dose. She did have mild case of COVID in Nov2020 and they are hoping she had antibodies from the infection and the first dose. Her primary care doctor was reviewing the blood work she had done at the hospital and told her they were surprised the hospital didn't admit her for observation because her pulse ox was low and there was another test that she was questioning because the d-dimer was very high. They did a chest x ray with unknown results. The doctor was questioning why they didn't do something else to rule out a blood clot. Therapeutic measures were taken as a result of the events, deathly sick, DVT blood clot, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, diarrhea, ankle was still swollen and uncomfortable/discomfort, nights were the worst for the pain, pulse ox was low, and d-dimer was very high. The clinical outcome of the events, deathly sick, fainted, severely nauseous, vomiting, diarrhea, was recovered on 27Mar2021. The clinical outcome of the events, DVT blood clot and nights were the worst for the pain, pulse ox was low, and d-dimer was very high, was unknown. The clinical outcome of the event, fracture of ankle/two fractures on her ankle, was recovering. The clinical outcome of the event, ankle was still swollen and uncomfortable/discomfort, was not recovered. No follow-up attempts are needed. No further information is expected.
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| 60 | 2021-05-02 | joint pain | Entire left side of body (shoulder, arm, leg) is in extreme pain, and unable to walk. |
| 60 | 2021-05-04 | neck pain, back pain |
blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back ha...
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blood pressure (BP) went over 269/149, it made my blood pressure go up.; left side of middle back had some excruciating pain; Nauseous; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I had a major body ache; it started hurting the minute she put it in my arm/Excruciating pain; pain in the neck down the arm; I got a mark on my arm, my arm started swelling; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0164/expiration date: 30Jun2021), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6208/expiration date: not provided), via an unspecified route of administration, on 16Mar2021 (at the age of 60 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION and experienced a headache. Relevant ongoing medical history included Diabetes Type II from about 5 years ago in 2016, fibromyalgia diagnosed about 6 years ago in 2015, and high blood pressure. Concomitant medication included gabapentin from an unspecified date at 600mg 3x/day for fibromyalgia, empagliflozin (JARDIANCE) from an unspecified date at 10mg 1x/day for Diabetes Type II, clonidine from an unspecified date at 30 mg, 2x/day for high blood pressure and labetalol from an unspecified date at 200 mg, 2x/day for high blood pressure. On an unspecified date in Mar2021, the patient experienced her blood pressure (BP) went over 269/149, it made my blood pressure go up, which required hospitalization overnight. Also on an unspecified date in Mar2021, the patient experienced a mark on her arm, and her arm started swelling. On 16Mar2021, the patient experienced major body ache, described as it started hurting the minute she put it in her arm, excruciating pain and pain in the neck down the arm, and she was nauseous. She described that she couldn't get out of the bed because of so much body pain. On 21Mar2021, the patient experienced her left side of middle back had some excruciating pain. The clinical course was as follows: I had a major body ache with the second vaccine. I did not have any problem except the headache with the first one but I took second one on this past Friday, I got very nauseous, it started hurting the minute she put it in my arm, which is on the left side. I got a mark on my arm, my arm started swelling. Saturday morning I couldn't get out of the bed because of so much body pain, Sunday my left side my middle back I had some excruciating pain I rushed to the doctor to the ER, my BP went over 269/149 and they had to give me pain medicine and BP medicine to reduce the blood pressure. I made it to the doctor and I'm getting medicine for the pain. I woke up in the morning there's pain in the neck down the arm and it's aching, the side I got the shot, the side is hurting, excruciating pain in my arm. I had to go to the ER straight to my doctor's office, they wouldn't let me drive or anything straight to the ER where they administered 2 doses of pain medicine and 3 doses of blood pressure, the pain was so intensive it made my blood pressure go up, the doctor said all of this was coming from the vaccine." Relevant lab data on an unspecified date in Mar2019 included blood pressure 269/149. The patient received treatment for the events blood pressure high, body pain, neck pain, pain in arm, and back pain. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021446955 same reporter/patient/drug, different event in separate dose
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| 60 | 2021-05-06 | muscle pain |
Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eye...
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Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stemming from the second dose of the COVID vaccine. The outcome of the events "Dry heaves, Bilious vomiting, Dehydration, Her throat closing up and it being sore from vomiting and dry heaving, Unable to swallow, Dry mouth, Nauseous" was recovered on 17Apr2021. The outcome of events "Feeling of warmth, Vaccination site pain, Hyperaesthesia, Vaccination site erythema, Tiredness" not recovered. The outcome of the event "Headache" was recovering. The outcome of other events was unknown. No follow up attempts are needed. No further information is expected.
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| 60 | 2021-05-07 | musculoskeletal stiffness |
started scratching and now the holes are open on areas to her chest; stated that the left side of he...
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started scratching and now the holes are open on areas to her chest; stated that the left side of her face is hard as a rock; Has rash on left side of face down to chest with blistery spots; could not breathe/cannot catch her breath every now and then; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 60-year-old, dose 1 via an unspecified route of administration, administered in right arm on 17Apr2021 (Lot Number: EW0171) as single dose for COVID-19 immunisation. Medical history included high blood pressure; and bad feet since 2004. The patient's concomitant medications were not reported. The patient had first vaccine on 17Apr2021. On 18Apr2021, she had a reaction, could not breathe. She cannot catch her breath every now and then and had to use the Epipen. Has been using nebulizer. Has more Epipens in case something else happened. Stated that she has a rash on the left side of her face down to her chest with blistery spots and that the left side of face was hard as a rock on 19Apr2021. Stated that the rash was worst on her chest. Has put some cream on the rash but it burns. Had a pain cream called Volten that she put on it because the rash was painful but that made it worst. Stated that she started scratching and now the holes are open on areas to her chest on 21Apr2021. Stated that she had to wear low shirts because her shirts were rubbing her chest. Stated that she was told by her doctor not to take the second shot that was scheduled for 17May2021. Stated that she has scheduled doctor's appointments that were fine. The patient wanted to know if she could get something in writing to submit with her passport stating the she could not have the second shot. The outcome of the event could not breathe/cannot catch her breath every now and then was recovered with sequel, and for the rest of the events was not recovered.
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| 60 | 2021-05-07 | neck pain, joint pain, muscle pain |
High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; ...
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High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 60 | 2021-05-14 | muscle pain |
This is a spontaneous report from a contactable consumer (patient). This 60-year-old female (no preg...
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This is a spontaneous report from a contactable consumer (patient). This 60-year-old female (no pregnant) patient received 2nd dose of BNT162B2 on 14Apr2021 03:45 PM on Left arm at single dose for covid-19 immunization. Medical history was Myasthenia Gravis. Past drug was allergies to Z pack. Historical Vaccine was 1st dose of BNT162B2 on 24Mar2021 03:45 PM on Left arm for covid-19 immunization. No other vaccine in four weeks. Other Medications in Two week included Olmesartan, Calcium. On the second day of the second dose of Pfizer (15Apr2021), she had the expected side effects, such as chills, muscle pain during the day. But, around 11 p.m. she suddenly started having abdominal pain, then throwing up, cold sweats, shivering, dizziness. She was taken to ER that night. The ER doctor did a CT, lab work but didn't find anything remarkable, so she was sent home. The next day (16Apr2021) she found blood in the toilet when she had bowel movement, so she went to see family doctor. He confirmed it's blood. He then set up an appointment for her to see a specialist the next Monday, since it's Friday afternoon. The bleeding got worse at night (16Apr2021), so she went to that ER again. She was then admitted to the hospital due to the big drop of red blood cell count. Later, the specialist did a colonoscopy on her and the result showed ischemic colitis. She was released from the hospital on 18Apr2021. This is very surprising to her as she had never had GI problems before. Events results in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (2 days). Outcome of the event was Recovering. No covid prior vaccination. No covid tested post vaccination. Information on the lot/batch number has been requested.
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| 60 | 2021-05-18 | muscle pain |
Numbness; Headache; Dizziness; extreme fatigue; muscle aches; she saw white flashes in front of the ...
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Numbness; Headache; Dizziness; extreme fatigue; muscle aches; she saw white flashes in front of the eyes; She got some bumps that are itchy on the ankle; Bell's palsy; facial paralysis; Lyme disease/had a bunch a symptom and flare up; Lyme disease/had a bunch a symptom and flare up; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 15Apr2021 12:00 (Batch/Lot Number: EW0158) at single dose for COVID-19 immunisation. Medical history included High Blood pressure, Chronic Lyme's Disease, Rocky mountain spotted fever, Psoriasis. She had Bells Palsy with her Lyme's disease 15 years ago. She also added that she was diagnosed about a year with rocky mountain spotted fever. Lyme's disease and rocky mountain spotted fever are both tick born diseases. She also had Bells palsy with the rocky mountain spotted fever. She had mild psoriasis, once a year she got little spots on both arms little patches of skin that were scaly, other then shots been. Concomitant medications included routine blood pressure medication .Patient stated she reported the side effects to the nurse on the other line. she wanted to know if you have information on the vaccine given to individual with Lyme disease. she received the first shot of the Pfizer COVID-19 shot on 15Apr2021. she had a bunch a symptom and flare up. she had facial paralysis which began 24 hours after receiving the vaccine. she worried about getting my second shot. Patient also wanted some clarification on the reported Bell palsy post vaccination. Patient stated that she was calling about the covid vaccine, she had had chronic Lyme disease for a long time and when she got the vaccine it triggered a lot of old symptoms. She was trying to call doctor and health department. She was scheduled for the second dose on this coming Monday 03May2021. She wanted to question if there was research on people with Lyme's diseased. The symptoms she experienced was bells palsy, noticeable numbness in lips to nose to cheeks that occurred about an hour and a half after shot, the bells ballsy was in the center of her face clarifying on both sides of the face. She spoke for a living and her face went numb that didn't make sense. She also still had a headache for 2 weeks every day, she saw white flashes in front of the eyes, some dizziness, extreme fatigue, and muscle aches. She also went to the chiropractor once a week for back pain and it hadn't been helping. The Chiropractor said that a bunch of patients have been complaining since the shot that the chiropractic wasn't working as well. She got some bumps that are itchy on the ankle, no bugs are outside yet, it's a couple itchy bumps, she didn't know if it's related. Patient clarifies that the bumps she had was 1 on ankle and 1 on hip, and 1 below belly button, it started a couple days ago. No follow-up attempts are needed. No further information is expected.
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| 61 | 2021-01-03 | joint pain |
Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, ...
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Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, Itching all over body, scalp pain and tenderness. 12/28 Began feeling better, mild cough persists. 1/4: Feels as though she has "bad flu" fever of 101 F.
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| 61 | 2021-01-04 | joint pain |
Patient describes feeling feverish, joint aches in elbows and knees, body aches, red rash at knees a...
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Patient describes feeling feverish, joint aches in elbows and knees, body aches, red rash at knees and elbows and arm pain at injection sites. This is the 2nd dose, patient reports no adverse reactions on the first dose.
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| 61 | 2021-01-04 | muscle pain |
Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills...
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Headache; muscle aches and pains; feels like she is getting a fever; thinks she is having the chills; feeling a little warm/ She is cold, too; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) intramuscular on left arm, near the top (in the muscle), at single dose for vaccination on 29Dec2020 at 12:45 pm at 61-year-old. Medical history included: hay fever allergies, allergic to prochlorperazine maleate (COMPAZINE). Concomitant medication was not reported. No additional vaccines administered on same date of the Pfizer vaccine. On 30Dec2020, the patient stated her headache started about an hour and a half ago. She started having the muscle aches and pains when she woke up this morning. She felt like she was getting a fever, but she was at work and couldn't take her temperature. She was feeling a little warm, she was cold, too. She was having the chills. The patient confirmed all of these symptoms just started happening this morning (30Dec2020). No emergency room nor physician office visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.
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| 61 | 2021-01-05 | neck pain |
couldn't lift my head off my pillow; severe pain in neck; squeezing on a nerve; had soreness in my a...
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couldn't lift my head off my pillow; severe pain in neck; squeezing on a nerve; had soreness in my arm; This is a spontaneous report from a contactable nurse, the patient. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 (at the age of 61 years old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 18Dec2020, the patient experienced soreness in her arm that was gone by the next day. On 23Dec2020, while driving home, she felt severe pain in neck. She almost felt like something went up in her neck and started squeezing on a nerve. It proceeded to get bad so she took muscle relaxants. Christmas day was horrible, she couldn't lift her head off her pillow. The pain came from up head, under her clavicle and down her back. Her pain started getting better, but then next morning it up started again. The only way she's able to get some sleep is to take Flexeril, 800mg of Motrin and applying moist heat. The clinical outcome of severe pain in neck, squeezing on a nerve, couldn't lift her head off her pillow was unknown, and for event had soreness in her arm was recovered on 19Dec2020. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 61 | 2021-01-06 | joint pain, muscle pain |
Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction last...
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Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction lasted 3 days, employee did not report to work on day 3 after vaccine.
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| 61 | 2021-01-07 | joint pain | Arthralgia fatigue Narrative: |
| 61 | 2021-01-07 | muscle pain, joint pain | Headache, Myalgia, Arthralgia, decreased appetite, general malaise, some abdominal discomfort |
| 61 | 2021-01-08 | joint pain, muscle pain |
muscle pain in left shoulder blade and under left breast; rash which resembles shingles without blis...
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muscle pain in left shoulder blade and under left breast; rash which resembles shingles without blistering; redness on left should blade and over left breast
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| 61 | 2021-01-08 | joint pain |
01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to thi...
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01/08/21 02:30am on set of headache, 01/08/21 05:15am nausea Headache, called in for work due to this being so bad, 01/08/21 08:54am hip pain/throbbing, took motrin. reported difficulty to bear weight, stayed in bed all day. 01/09/20 01:00pm reports much improved continues with slight pain today, but able to ambulate and function without problems.
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| 61 | 2021-01-08 | musculoskeletal stiffness |
First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next da...
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First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next day. Dose two given on 01/07/21 with onset of shaking chills on 01/08/21 at 2:00am, ensuing fever max 101.7 degrees Fahrenheit, at 4:00 am noticed redness of eyes, face flushed with burning feeling, headache, dizziness, blood pressure of 184/96 and heart rate of 153. This required medical evaluation and treatment with IV fluids and Toradol for resulting headache. Patient also self administered 1000mg oral Tylenol prior to ER evaluation.
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| 61 | 2021-01-09 | joint pain | Headache, nausea, body aches, joint pain, fatigue. |
| 61 | 2021-01-10 | joint pain | joint pain starting one week after vaccine and lasting more than 5 days |
| 61 | 2021-01-10 | back pain | SORE ARM,HEADACHE LOWER BACK PAIN FATIGUE |
| 61 | 2021-01-10 | muscle pain |
Slight headache the night I received the dose, shot site redness and muscle pain for 2 days after r...
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Slight headache the night I received the dose, shot site redness and muscle pain for 2 days after receiving dose
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| 61 | 2021-01-10 | muscle pain | Headache (moderate to severe), chills, fatigue, muscle aches, skin sensitivity |
| 61 | 2021-01-10 | muscle pain | Diagnosed with COVID-19, Fatigue, Bodyaches(severe), Myalgia, Fever, Diarrhea, GI Discomfort |
| 61 | 2021-01-11 | joint pain |
Arm pain post injection Severe pain in shoulder joint, down arm, pain elbow, pain firearm and hand o...
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Arm pain post injection Severe pain in shoulder joint, down arm, pain elbow, pain firearm and hand on left side. Diagnosed as reactive arthritis due to vaccine
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| 61 | 2021-01-11 | muscle pain | myalgias, chills, left arm soreness, vertigo |
| 61 | 2021-01-12 | weight decreased |
Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and mo...
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Initially mild nausea, moderate abdominal cramping for 30 minutes then severe watery diarrhea and moderate to severe abdominal cramping with moderate chills lasting 6 hours. Any fluids taken ran right through me. 4 lb weight loss and muscle cramping from dehydration. 12 hours after symptoms started I was able to take fluids and eat crackers. 24 hours after start felt shaky with mild abdominal soreness but improvement progressed and by 28 hours after start if symptoms felt normal other than I felt like I did 100 sit ups!
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| 61 | 2021-01-13 | joint pain, muscular weakness |
Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at ...
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Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at injection site. Swelling at injection site. Diarrhea for 2 Days
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| 61 | 2021-01-13 | muscular weakness, muscle pain | Fever, muscle weakness, muscle pain |
| 61 | 2021-01-14 | joint pain, neck pain |
trouble lifting things like my tea kettle; lot of pain in right elbow; bad neck and shoulder pain; b...
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trouble lifting things like my tea kettle; lot of pain in right elbow; bad neck and shoulder pain; bad neck and shoulder pain; sore right arm similar to after a tetanus shot; This is a spontaneous report from a non-contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: EL1284, intramuscular on right arm from 05Jan2021 09:45 to 05Jan2021 09:45 as single dose (first dose) for COVID-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On 05Jan2021 at 03:00pm, the patient experienced sore right arm similar to after a tetanus shot. On 06Jan2021, the pain in upper arm gone but by afternoon but the patient got bad neck and shoulder pain on right side that she treated with heat and Advil. On 07Jan201, neck pain still present and by late afternoon, the patient got a lot of pain in right elbow. On 08Jan2021, the patient still have the neck to shoulder pain in addition to the right elbow pain. It feels like she sprained her elbow and was having trouble lifting things like my tea kettle. The outcome of the event sore right arm/pain in upper arm was recovered on 06Jan2021; having trouble lifting things like my tea kettle was unknown; while the other events were not recovered. Treatment has been given for the event bad neck and shoulder pain. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts are possible. No further information is expected.
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| 61 | 2021-01-14 | armpit pain |
Received the 2nd vaccine at 10am on 1/11/21 intramuscular in the right arm. At 3pm on the same day, ...
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Received the 2nd vaccine at 10am on 1/11/21 intramuscular in the right arm. At 3pm on the same day, I had a painful swolle lymph node on left side of neck. That same evening I developed pain, swelling, in my right armpit radiating to the right upper breast and down my right arm with a swollen lymph node under the right arm pit. The pain was about a number 7 on a scale of 1 to 10. The pain and swelling still persist today on 1/15/2021 Still painful, especially to touch. Still radiating down the arm. Lymph node still swollen The pain is about a 2 on a scale of 1 to 10
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| 61 | 2021-01-14 | back pain, neck pain |
Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at inje...
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Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at injection site radiating up and down arm and up into neck ; Body aches especially lower back developed within 24 hours with a severe throbbing type headache and ringing in the ears. Elevation of temperature by 1-2 degrees normal for me runs 97 degrees F and was up to 99 degrees F. Headache intensified with movement(ex. .bending over ,etc) Treated arm soreness and lower back with heat compresses... elevated temp and headache with rest and a lot of water. It is now over 48 hours since vaccination and all symptoms are subsiding but still present with temperature normal for me and no arm soreness. Scheduled day off from work day after vaccination but also a second day due to the severe headache mostly.
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| 61 | 2021-01-15 | joint swelling |
Total body rash with severe ankle and feet swelling and peeling that continues even after getting v...
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Total body rash with severe ankle and feet swelling and peeling that continues even after getting vaccine more than 3 weeks ago
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| 61 | 2021-01-16 | muscle pain |
"Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle...
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"Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle pain, fever, loss of appetite, HR in lower 90's, pulse OX in low 90's.
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| 61 | 2021-01-17 | joint pain, armpit pain |
i1/13/21 at about 2;45 pm, I had my second Covid vaccination. had pain on site on left arm 1/14/21 ...
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i1/13/21 at about 2;45 pm, I had my second Covid vaccination. had pain on site on left arm 1/14/21 woke up feeling a little tired, went to work. went home early at 1:30 pm, feeling a little chilly. no fever. 1/15/21 in the morning noted pain on Left armpit ( injection site is left arm), pain from left shoulder blade to right shoulder blade. took advil. In the afternoon, about 4:00 pm, noted some swelling and soreness on left armpit. took Advil.. 1/16/21, Called employee health to report this. Advised to take advil and monitor and call pcp if symptoms persists.
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| 61 | 2021-01-17 | joint pain, neck pain |
Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left...
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Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left side of face, joint pain, headache and neck pain. Lasted about 3 hours, shaking stopped but had chills that lasted all night. The next day, no appetite but when she ate something, she vomited. Worse things were shakes, headache and neck pain and vision. . Had vision problems. Eyes were swollen and jittery and hard to focus. The swelling went away but still unable to focus. Everything has gone except vision issue.
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| 61 | 2021-01-17 | muscular weakness |
Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a ...
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Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a circular redden skin rash on her arms, legs, and torso. Temperature: 99 degrees. Employee took Tylenol and Claritin for rash, complained of diarrhea, vomiting, and weakness of both knees within 24 hours all symptoms were gone.
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| 61 | 2021-01-18 | armpit pain |
24 hours after my 2nd vaccine I had symptoms of severe fatigue and body aches. I had a low grade fev...
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24 hours after my 2nd vaccine I had symptoms of severe fatigue and body aches. I had a low grade fever and headache. The following morning I had pain in my left axilla, low grade fever, headache and body aches. I left work early because of severe fatigue and was out the following day for symptoms due to covid vaccine.
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| 61 | 2021-01-18 | muscular weakness |
Though I had pain and soreness in the arm after both the shots I am left with a residual weakness an...
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Though I had pain and soreness in the arm after both the shots I am left with a residual weakness and ache in the arm almost a month later. I find I am not able to lift items that I was able to lift last month and there is a lump in my left upper arm that is new as well.
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| 61 | 2021-01-19 | joint pain, muscle pain |
Joint pain (all joints felt like they were on fire - different than usual arthritis pain - could bar...
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Joint pain (all joints felt like they were on fire - different than usual arthritis pain - could barely walk or hold a cup of water due to pain), significant fatigue (barely able to get out of bed) recurrence, brain fog recurrence, headache , muscle pain, I felt almost like I did when I had COVID - starting to subside now 4 days after vaccination
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| 61 | 2021-01-19 | joint pain |
Could not raise right arm above shoulder. Extreme fatigue. Sneezing with first shot. Sneezing, achi...
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Could not raise right arm above shoulder. Extreme fatigue. Sneezing with first shot. Sneezing, aching in joints., headache, chills with second shot.
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| 61 | 2021-01-19 | muscular weakness | Tingling in left face check..legs very weak .. congestion..very tired for 4 days |
| 61 | 2021-01-20 | joint pain |
The first thing I had nausea and stomach pain (for 2 days) in the AM and then it went to achy, joint...
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The first thing I had nausea and stomach pain (for 2 days) in the AM and then it went to achy, joint hurting and headache. It was not like I could not work or anything, it was just there. On the 9th day I woke up with fever and chills and a super bad headache and I felt so bad I could not even go seek medical care, I finally went after 3 or 4 days feeling like that. At the walk in clinic they tested me for flu, covid and strep and on the rapid the result was negative but when done the PCR it came back positive (around 12/29/20). I did not have any respiratory issues on this one. I do remember having diarrhea.
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| 61 | 2021-01-20 | muscle pain | Global myalgia, chills, high fever, significant arm pain. Excedrin used. Symptoms mostly resolved. |
| 61 | 2021-01-21 | back pain, joint pain |
STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine....
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STarted having nausea around 10am on 1/21/21, then at noon started having chest pain and a migraine. Went home early from work. As of 1/22/21 0830, still has chest pain but not as intense and it radiates to left shoulder and towards back (advised employee to have this evaluated)
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| 61 | 2021-01-21 | muscular weakness, joint pain |
I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs fe...
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I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.
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| 61 | 2021-01-21 | muscle pain |
Had when I woke up at 6 am set on Jan 22, 2021 still ongoing Sore throat, severe headache, nausea, ...
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Had when I woke up at 6 am set on Jan 22, 2021 still ongoing Sore throat, severe headache, nausea, muscle ache, light headness, dizzy. January 22, 2021 temp 100.1 tympanic
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| 61 | 2021-01-23 | neck pain | Severe base of neck and frontal head pain. Unable to sleep. Lasted x 2 days; 01-18 & 01-19-21. |
| 61 | 2021-01-24 | joint pain |
At day 20 after the vaccination I got up in the middle of the night & could barely walk. My knees we...
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At day 20 after the vaccination I got up in the middle of the night & could barely walk. My knees were very painful 10 out of 10. As the day progressed it got worse & I needed a walker & eventually a wheelchair.
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| 61 | 2021-01-24 | joint pain |
On day 20 after the vaccination my knees starting getting sore- by 3 am I could barely stand on them...
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On day 20 after the vaccination my knees starting getting sore- by 3 am I could barely stand on them- as the day progressed I had to use a walker & by late afternoon a wheelchair. The pain in my knees was a 10 out of 10.
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| 61 | 2021-01-25 | back pain |
No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache...
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No problems with first vaccine. Started having severe head aches 2 days after the vaccine. Back Ache after 5 days on the right side. Throwing up 6 days after for 3 days. Went to the hospital 10 days later for four days was taken by ambulance because she was to ill to drive.
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| 61 | 2021-01-26 | joint pain |
Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, sl...
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Approx 18 hours after the vaccine: Cold and hot flashes with chills (no fever) weakness, fatigue, slight left arm ache, loss of appetite, insomnia, body/joint aches. I took a couple of Aleve tabs 24 hours after the vaccine and then switched to 500 mg Tylenol 30 hours after the vaccine, with no relief of symptoms from either meds. I've been sleeping (taking 2 hour naps) and called off of work (I work in home health). Today, 1.27.21 I feel better, still having 'hot flashes' and some chills (again, without fever). I feel tired, slept last night for 12 hours (no further insomnia). I am eating, but really have no appetite.
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| 61 | 2021-01-26 | musculoskeletal stiffness, muscle pain, neck pain |
unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffnes...
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unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 61 | 2021-01-26 | muscle pain, joint pain | Headache 1st day Day 2/3 severe body aches, muscle and joint pain, fatigue, brain fog, insomnia |
| 61 | 2021-01-27 | back pain, neck pain | Headache Chills Neck hurt Back hurt |
| 61 | 2021-01-27 | neck pain, back pain |
12/31/20:left a message saying she got the vaccine 5 days ago and is experiencing severe neck pain t...
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12/31/20:left a message saying she got the vaccine 5 days ago and is experiencing severe neck pain that shoots down her neck and back : saw PCP - f/u 1/8/21 :I still have a little neck pain left and my glands are still slightly swollen. Getting my 2nd dose today. I have paperwork from Pfizer that I need to fill out for their data keeping. Pain was excruciating for nearly 2wks and started to settle down a few days ago, where I don?t have to sit with a heating pad or take motrin and flexaril. f/u 1/28/21-"My neck still hurts, worse on certain days, but is bearable. I haven?t had any imaging done and just heard of another person with same symptoms. My 2nd dose was fine. No pain at all, not even at injection site. I will keep you posted if anything changes. I?m hoping it will just go away on it?s own. I?ve heard it takes months". Referred employee back to PCP.
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| 61 | 2021-01-28 | joint pain |
Pain in shoulder joint starting the morning after I received my first dose. Continued till date of m...
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Pain in shoulder joint starting the morning after I received my first dose. Continued till date of my second dose and got worse after 2nd dose given in same arm due to medical recommendation for better vaccine response. Have pain on lifting arm. Can?t raise it more than 75 degrees without great pain. Trouble pulling or pushing with that arm or carrying heavy things. Have not had issues with this arm before vaccination.
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| 61 | 2021-01-28 | joint swelling |
This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (n...
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This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EL3294 and Expiration Date unknown) via an unspecified route of administration on 11Jan2021 07:15 AM (Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EK5730 and Expiration Date unknown) via an unspecified route of administration on 21Dec2020 03:45 PM (Left arm) at single dose for COVID-19 immunisation.No covid prior vaccination, no covid tested post vaccination and no known allergies.Other medical history included thyroiditis and scleritis The concomitant medications included Levothyroxine, Vitamins, paracetamol (TYLENOL), Pepsid, Melatonin. No other vaccine in four weeks. Patient experienced, fatigue, left under eye bruise, right eye injection, joint swelling, gum bleeding with brushing on 13Jan2021 08:00 AM, resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered with unknown treatment.
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| 61 | 2021-01-28 | muscle pain, muscle tightness |
Headache/Could not pick my head up; All the muscles in my shoulders and my back were tightened up/mu...
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Headache/Could not pick my head up; All the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck; Muscle pain; muscles in my neck are all tied up between my shoulder blades, my shoulders all was shrugging and I could never release the muscles back that is what I felt like.; Could never release the muscles back that is what I felt like/My muscles never acted this way; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number, expiration date unspecified), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Nurse reported that she had severe side effects but not an allergic reaction. She had the vaccine on Thursday (31Dec2020) and by Sunday (02Jan2021), she had a horrible headache, all the muscles in her shoulders and back were tightened up. And all the week long, she kept trying to keep care with hot packs and cold packs and Advil and Maxalt and all kind of things but could not. Yesterday morning (as reported), she lifted nothing heavy, did nothing different at all and she could not pick her head up. Patient had to seek for medical attention just at her doctor's office not at the hospital. She had to have somebody and take care of muscle pain. She still have the muscle pain she do have to go back but they did give a muscle relaxant. Patient reported that she never had a reaction ever like this. Nurse further stated that she didn't do anything as a precursor before the vaccine or after the vaccine. The muscles in her neck were all tied up between her shoulder blades, and her shoulders all was shrugging and could never release the muscles back that was what she felt like. Nurse stated that she just have to take the second shot, that was just the first one. Somebody told her that she have to report it because it took her off the work for two days. And her muscles were still tight and at all the way to my neck and still have headache. She had a shot on 31Dec2020, and symptoms started on the 2nd. Patient reported that she never had such kind of pain before and her muscles never acted this way. She was advised by her healthcare provider that there were side effects and this one she consider severe. She was advised to continue to take the second one. Outcome of the events headache/could not pick my head up and all the muscles in my shoulders and my back were tightened up/muscles are still tight and at all the way to my neck were not recovered; outcome of the rest of events was unknown. Information on the Lot/Batch number has been requested.
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| 61 | 2021-01-29 | muscle pain, joint pain |
alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves ...
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alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.
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| 61 | 2021-01-30 | muscle pain |
12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, fe...
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12 hr after vaccine, sore arm, a little achy. 15 hrs after vaccine (11 pm) and through the night, felt very cold and had difficulty getting warm, headache, all body achy, unable to get into any comfortable position and very limited sleep. By 24 hr after vaccine and continuing until 40 hr after, nausea most of day, severe muscle pains, headache, difficulty moving from pain and general weakness, head swimming sensation. felt like skin crawling sensation all over. By 48 hrs, much less headache and nausea, able to eat, still had skin crawling sensation and achy but able to walk around a bit, not able to go outside. By 58 hr after (at time of report), just weak all over feeling, head fuzzy but better. Treatment: ondansetron x 2 doses (at 24 hr and 20 hr), Nurtec x 2 doses at 15 hr and 20 hr), Acetaminophen 8 hr x 2 doses (at 36 hr and 48 hrs)
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| 61 | 2021-01-31 | joint pain |
Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness...
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Received second dose of Pfizer COVID vaccine on 1/17/2021 at about 10:30 am. Started having soreness in arm, headache, and fever of 99.4 at about 2:30am on 1/18/2021. Side effects persisted all day on 1/18/2021 but relieved with acetaminophen 325mg every 6 hours. All side effects resolved by morning of 1/19/2021. Around 4:30pm on 1/19/21 started having pain in left axilla which was due to swollen lymph node. The pain and swelling progressed over the evening and pain radiated to chest, throughout left arm, and shoulder. All of these side effects continued all day on 1/20/21 but started getting better around 6pm. All side effects resolved by morning of 1/21/2021.
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| 61 | 2021-01-31 | neck pain, back pain |
(This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she ...
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(This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she in fact received the Pfizer.) I got the 2nd dose of the Pfizer vaccine late last Wednesday afternoon (1/20). Before the 2nd dose, I premedicated (as instructed by my medical office) with Benadryl 50mg and Pepcid 20mg (for the histamine blocking effect) since I had terrible itching for about 36 hrs after the 1st dose; but the itching didn't begin-after the 1st dose-until about 8hrs after the shot & became intense 2 more hrs later. I had itching the night of the 2nd dose that kept me awake part of the night but was FAR less intense than after the 1st dose. I came to work Thurs not feeling ill--just cold and tired all day (I attributed to the cold weather and not sleeping well). Thurs about noon I began feeling ill--like I was coming down with the flu; I went home after my shift and found my temp to be 100.4. Shortly thereafter it was 100.9. I thought it would pass by morning so I just showered, drank fluids, took Tylenol and slept. By 0200ish Fri 1/22 I still had a fever of 100.9 (even with Tylenol on board), a bad headache, sinus congestion, and significant neck and back pain so I called out for work. I continued to treat the fever and by noon Fri the fever finally had resolved-along with the head, neck and back pain. I've been fine since.
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| 61 | 2021-02-01 | neck pain, joint pain |
Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hur...
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Slight fever/ her temperature usually runs 97 and currently is 99.4; joint pain because her hips hurt/ her hips were really sore; Chills; Arm pain; Headache/ pain at the base of the head/ pain in her head; Neck pain; Shoulder pain; pain everywhere; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ16R6), intramuscular in the left arm on 17Jan2021 09:30 at single dose for COVID-19 prophylaxis. The patient medical history was not reported. There were no concomitant medications. The historical vaccine included the first dose of BNT162B2 on 26Dec2020 at her 60-year-old for COVID-19 prophylaxis. The patient was a physical therapist (non- Healthcare Professional), she received the second dose and was having almost every side effects. She experienced arm pain started night around 17Jan2021 17:00; headache, pain at the base of the head, neck pain, shoulder pain, pain everywhere on 17Jan2021; chills that she couldn't get rid of on 17Jan2021 19:00; slight fever, and overall feeling tough, joint pain because her hips hurt on 18Jan2021. At 17:00-19:00 on 17Jan2021 and stated that she could not tolerate her head being upright. She stated that she went to bed at 19:00. Pain in her head, neck, and shoulders is a little better because she can actually sit up now and hold her head up. She said that her temperature usually ran 97 and currently was 99.4. She said that she did not take her temperature on 17Jan2021 and did not get up until 13:00 and stated that she took it when she got up on18Jan2021. She noticed joint pain when she got up on 18Jan2021, her hips were really sore. Chills started at night, when she went to bed she had the chills around 19:00 17Jan2021. The outcome of pain in her head, neck, and shoulders was recovering, of the other events was not recovered.
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| 61 | 2021-02-01 | weight decreased |
lost 22lbs; teeth hurting; can't eat; sores in mouth; cold chills; Headache/it's mainly in the back ...
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lost 22lbs; teeth hurting; can't eat; sores in mouth; cold chills; Headache/it's mainly in the back of her head; Diarrhea; Throwing up/threw up 4 times; low grade temp of 100; This is Spontaneous report from a contactable consumer reporting for self. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration in Right arm on 14Jan2021 10:00 at single dose for covid-19 immunisation. Patient received 1st dose of bnt162b2 on 24Dec2020, Lot number: EL0140; She only had a little aches with the first dose. States that she has had Covid before. There were no concomitant medications. She got the 2nd covid vaccine and felt like she got Covid all over again, diarrhea, throwing up, cold chills, and headaches started on 15Jan2021 at around 2:00AM, low grade temp of 100 on 15Jan2021, then she got sores in her mouth and now her teeth hurt. States that maybe it's from the fever. States that she can't eat because it hurts. She lost 22lbs because she couldn't eat. She has been gargling with half warm water and half peroxide. States that she threw up 4 times, but she doesn't even remember how many times she had diarrhea. After she was done throwing up she finally sat down and took her temperature, so it was probably around 4:00-5:00 AM. States that she still has a headache; it's mainly in the back of her head. Outcome of event diarrhea, throwing up, low grade temp of 100, chills was recovered, of headache was recovering, of can't eat and lost 22lbs was unknown, of others was not recovered.
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| 61 | 2021-02-02 | joint pain | Migraine headache chills and joint pain |
| 61 | 2021-02-02 | muscular weakness, muscle pain | severe headache muscle weakness muscle pain |
| 61 | 2021-02-02 | muscle pain |
FATIGUE, SORENESS AT INJECTION SITE, MUSCLE ACHES, DIZZINESS, LIGHT HEADEDNESS, MUSCLE AND BODY ACHE...
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FATIGUE, SORENESS AT INJECTION SITE, MUSCLE ACHES, DIZZINESS, LIGHT HEADEDNESS, MUSCLE AND BODY ACHES
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| 61 | 2021-02-04 | joint pain | BODY ACHES, CHILLS, JOINT PAIN, ARM SORENESS |
| 61 | 2021-02-04 | muscle pain |
I experienced muscle aches the spread across my entire back starting at about 8 PM on 2/4/21. At 2:3...
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I experienced muscle aches the spread across my entire back starting at about 8 PM on 2/4/21. At 2:30 AM on 2/5/21, I passed out three times after rising from the toilet, resulting in a split lip. I was covered with sweat the third time I "came to" and soon got the chills.
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| 61 | 2021-02-04 | muscle pain |
Mild headache that evening, arm slightly sore during the night and the next day. Frontal headache a...
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Mild headache that evening, arm slightly sore during the night and the next day. Frontal headache and muscle aches the next day on 1/22/21. Some fatigue and nasal congestion that next day as well. Some fatigue and headache on 1/23/21. Took Tylenol once on 1/22 and 1/23.
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| 61 | 2021-02-06 | limb discomfort, neck pain, joint pain |
I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty ba...
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I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day
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| 61 | 2021-02-07 | joint pain |
Pt stated -Onset 12-16 hours post injection of shills, headache, body ache, joint pain and fatigue. ...
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Pt stated -Onset 12-16 hours post injection of shills, headache, body ache, joint pain and fatigue. The symptoms lasted a day and resolved.
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| 61 | 2021-02-07 | neck pain | Sore arm and neck on injection side |
| 61 | 2021-02-07 | neck pain |
Body aches; fever(100.1); chills; runny nose; cough; headache; fatigue; neck pain; head congestion; ...
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Body aches; fever(100.1); chills; runny nose; cough; headache; fatigue; neck pain; head congestion; This is a spontaneous report from a contactable nurse reporting for herself. A 61-year-old female patient (non-pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9261), via an unspecified route of administration on 20Jan2021 at single dose on left arm for COVID-19 immunisation. Medical history included Irritable Bowel Syndrome with Constipation (IBSC), anxiety, allergies, Known allergies: sulfa. Historical vaccine included 1st dose of BNT162B2 (lot: EL1284) on 28Dec2020 at 14:00 via intramuscular at single dose on right arm for COVID-19 Immunization. Concomitant medication included celecoxib (CELEXA [CELECOXIB]), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), lisdexamfetamine mesilate (VYVANSE) and linaclotide (LINZESS). The patient experienced body aches, fever (100.1), chills, runny nose, cough, headache, fatigue, neck pain and head congestion, all on 21Jan2021 at 14:45 with outcome of resolving.No treatment was received for the events. This case was reported as non-serious.
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| 61 | 2021-02-08 | joint pain |
From charting for point of care services before EMS transport: Chief Complaint: Immunization Visi...
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From charting for point of care services before EMS transport: Chief Complaint: Immunization Visit: Client received Pfizer Vaccine at 11:30am. At 11:32 am client reports "throat feels a little funny" and Chest tightness. No difficulty breathing reported. Lung sounds clear bilaterally per RN at 11:38am. Pt reports that her throat still feels funny after administration of benadryl by RN. Epi was administered at 11:40am by RN. EMS arrived at 11:42am. Client has is now complaining of jaw pain. Reports shoulder pain ( residual from recent accident). Vital signs obtained by RN Her husband was present when EMS arrived and will follow client to the hospital.
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| 61 | 2021-02-08 | joint pain |
Initially after injection I felt as if a rapid heart beat (but 60 minute pulse count was no more tha...
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Initially after injection I felt as if a rapid heart beat (but 60 minute pulse count was no more than 80 and was regular). Discomfort in arm began, progressed to inflammation and difficulty in movement of arm especially to lift arm. Used Tylenol or Motrin PRN for relief as well as heating pad intermittently. After 1/23 injection discomfort seemed to lessen but on 2/9 (4 days before second injection due) discomfort still persists. Due to persistence of symptoms seen in Urgent Care diagnosis Adhesive Capsulitis of right shoulder and acute pain of right shoulder. Treatment, Physical Therapy and Ibuprofen. Unable to use steroids due to diabetes. Follow up scheduled 2 weeks 2/16/2021.
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| 61 | 2021-02-08 | muscle pain |
On 2/5 am felt dizzy and nauseated. On 2/6 am felt dizzy and nauseated On 2/7 had child, abdominal ...
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On 2/5 am felt dizzy and nauseated. On 2/6 am felt dizzy and nauseated On 2/7 had child, abdominal cramping and pain , Temp 99.3 On 2/8 stomach uncomfortable, fatigue and muscle aches. 2/9 feel tired
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| 61 | 2021-02-10 | joint pain, muscle pain |
Injection Site Pain, tiredness, headache severe, muscle pain, chills, joint pain, fever, nausea, fee...
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Injection Site Pain, tiredness, headache severe, muscle pain, chills, joint pain, fever, nausea, feeling unwell, cough
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| 61 | 2021-02-13 | joint pain, muscle pain |
Wokke up around 3:00 a.m. 3 nights after vaccine. Violent vomiting 3-4 times, then diahhrea for abou...
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Wokke up around 3:00 a.m. 3 nights after vaccine. Violent vomiting 3-4 times, then diahhrea for about half hour. Thought I had food poisoning. Sever headache shortly after. Sunday, slight fever, listless, some muscle aches, joint pain. Sunday night, headaches returned. Monday, slight fever, muscle aches, swollen lymph nodes under right armpit. Some mild muscle aches and joint pain. Monday night, headache again. Tuesday, same symptoms. Wednesday, some joint pain, swollen lymph node, otherwise fine.
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| 61 | 2021-02-13 | back pain, musculoskeletal stiffness |
6:00 am next day woke with a really bad backache hard to walk or bend or pick up something. Felt li...
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6:00 am next day woke with a really bad backache hard to walk or bend or pick up something. Felt like that all day...very hard and stiff near back middle rib area both sides. Felt better if rested but if got up bad again. Very uncomfortable continued until the following morning. Got up today am 2/14 feel a lot better but slightly still there. Also had lymph node swelled a little in same arm as shot under collarbone. Hopefully my back isn't as bad as yesterday. Had to lay in bed a lot 2/13.
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| 61 | 2021-02-13 | muscle pain | cill, temperature (100,5), muscle pain. |
| 61 | 2021-02-15 | joint pain, musculoskeletal stiffness |
Left thumb and all the way to the wrist sore, inflammation, very painful, sore, tender, stiff. on a ...
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Left thumb and all the way to the wrist sore, inflammation, very painful, sore, tender, stiff. on a scale of 1 to 10 on pain, it is an 8. Keep thinking it will get better each day but it is not getting better.
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| 61 | 2021-02-15 | joint pain |
Developed generalized rash over body, more pronounced on knees and lower legs. Rash remains now but...
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Developed generalized rash over body, more pronounced on knees and lower legs. Rash remains now but is lighter. Significant L knee pain.
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| 61 | 2021-02-16 | muscular weakness |
Patient was administered vaccine at 11:00 AM in the left deltoid muscle IM. Patient reported feeling...
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Patient was administered vaccine at 11:00 AM in the left deltoid muscle IM. Patient reported feeling chest tightness, heaviness as if someone was sitting on her chest, pressure on her chest, and found it a little hard to breath at 11:10 am. Patient had a history of congestive heart failure and suffers from anxiety, but wasn't sure if the chest pain was due to her past medical history or the vaccine. At 11:17 am the chest pain remained the same. At 11:30 she was still feeling chest pressure and her right arm was feeling weak. At 11:30 Heart rate was 56, Blood Pressure was 138/72, and respiratory rate was 12. EMS was called at 11:35. Patient was taken to the hospital once EMS arrived.
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| 61 | 2021-02-16 | neck pain, back pain |
Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101...
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Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have
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| 61 | 2021-02-18 | muscular weakness |
Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs f...
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Around 1 am on 1/29/2021, hot flashes, fever 99, & a little bit nauseas this lasted 48hrs. My legs felt weak & shaky legs and fuzzy head. I feel with no energy. This symptoms are still going on.
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| 61 | 2021-02-18 | muscular weakness |
Around 2am on 1/8/2021 I woke up having chills, nauseas, fever, dizzy felt like I was going to faint...
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Around 2am on 1/8/2021 I woke up having chills, nauseas, fever, dizzy felt like I was going to faint, foggy head, very fatigue, shaky weak legs & body aches. The chills, body aches, fevers & dizziness were under 48hrs. The other symptoms lasted till 2 days before I got my second dose. Tight Chest going on but I think it might of been anxiety. Phone consult with doctor and prescribe some steroids.
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| 61 | 2021-02-20 | back pain | Headache, back pain, extreme fatigue, slight vertigo |
| 61 | 2021-02-20 | neck pain, musculoskeletal stiffness |
I want to report to Pharmacy and/or CDC what I have experienced with both shots (separate arms). In...
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I want to report to Pharmacy and/or CDC what I have experienced with both shots (separate arms). In both cases, my upper shoulders into my neck hurt and tighten the day after the shot. The following day it was gone but it returned on or around day 4 and it has not gone away. I have seen my medical doctor, acupuncturist, chiropractor and a massage therapist. My doctor believes the shot activated some sort of chemical tendonitis. I took my second shot last Friday, in the other arm hoping it was simply coincidental, but I am having the same experience. I wanted to know who I should call to report this and was curious if anyone else has experienced this challenge. Thank you.
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| 61 | 2021-02-21 | limb discomfort |
patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d After 2 days of va...
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patient reported: Mild headache after the vaccine, Headache resolved after 1-2 d After 2 days of vaccine she started feeling right leg heaviness (whole leg) , she was dragging when she walks But no visible swelling, pain, redness per patient, She states at that time she was able to stand and move leg fine but only when she walks she needed to drag No facial weakness , upper extremities symptoms . Had slurry speech intermittent for 1 week after vaccine (Currently none) Lasted for 2 weeks, then resolved completely. after that no symptoms at all. Now Waking fine, no facial weakness, no extremities weakness She did not call us at that time as she thought it is side effect of covid vaccine and thought it would go away. When she went for covid vaccine #2, they said she needs to contact primary care physician due to some symptoms after first vaccine,. then she called us for an advise. by the time she called, no symptoms of neurology. MRI brain: did not show any abnormalities Discussed with local Infectious disease specialist: not sure those were vaccine related or not, recommended to report.
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| 61 | 2021-02-22 | muscle pain | Severe dizziness, severe headaches, chills, muscle aches, malaise |
| 61 | 2021-02-22 | neck pain |
Right side upper arm ache spread to right side of neck and into headache at back and top of skull. ...
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Right side upper arm ache spread to right side of neck and into headache at back and top of skull. Persisted through night and spread down into right side of neck to left arm ache. Throat became red and right, then left side of tonsil became pus filled. Chills but no fever. Fatigue every day. Took 2-3 hour naps every couple of days and slept 8-10 hours through the nights. Headache off and on for 10 days. Throat remained red, becoming most sore late afternoons, voice hoarse. On and off drippy nose. On the 13th day I felt normal energy level in the morning but today, my 15th day at nearly 3pm, my normal energy is waning and throat becoming sore again.
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| 61 | 2021-02-23 | joint swelling | Red circular swelling at injection site; forearm and wrist swollen, wrist itchy. |
| 61 | 2021-02-23 | neck pain | 1. Facial numbness 2. Nausea 3. Pain in back of neck 4. Headache |
| 61 | 2021-02-24 | back pain |
Pain on right-side of back all the way to front of chest and under breast and part of right shoulder...
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Pain on right-side of back all the way to front of chest and under breast and part of right shoulder. Week prior felt sensation of "pins and needles" on back. Patient reports 1 blister spot on chest. Patient went to urgent care and was diagnosed with shingles. Doctor prescribed Valtrex and Ibuprofen.
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| 61 | 2021-02-24 | muscular weakness |
Had my 2nd vaccine 1/28/21. On 2/3/28, I has rashes, redness & itchiness upper chest. On 2/5/21, My ...
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Had my 2nd vaccine 1/28/21. On 2/3/28, I has rashes, redness & itchiness upper chest. On 2/5/21, My lymph nodes right neck is swollen, also painful mass around 2x3cm below right clavicle near the sternum. I also have flu-like symptoms, body weakness especially lower extremities. Rashes and itchiness upper chest still present. 2/9/21 : Lymph node swelling of right neck & below right scapula still present. Rashes & itchiness upper chest still present but controlled with hydroxyzine tablet. Flu-like symptoms still present. 2/11/21: Rashes & itchiness minimal, less medication needed. Lymph node swelling less, still gets tired easily. 2/19/21: lymph node below right clavicle bigger for 1 day. No more lymph node swelling right neck. Still gets tired easily. 2/24/2021: Lymph node below right clavicle 1x1 in size, not painful.
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| 61 | 2021-02-27 | musculoskeletal stiffness |
Pain at the injection site was typical for vaccination and was essentially gone by the next day. Hea...
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Pain at the injection site was typical for vaccination and was essentially gone by the next day. Headache started within one hour after vaccination and was severe 4 hours after vaccination. Next day morning I woke up with all my face swollen, runny nose, headache, stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year and dizziness. Face edema and runny nose subsided 3 days after injection. Stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year persists 7 days after injection. Dizziness and foggy head became worth 7 days after injection.
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| 61 | 2021-02-28 | armpit pain, back pain, joint pain |
arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips ...
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arm/joint pain, vomiting chills low grade fever overnight, headache. Severe pain in shoulders, hips and lower back lasted 3 days. lymph nodes in armpits very sore. headache lasted 2 days. vomiting lasted 8 hrs. fever(99-101) lasted 2 days. had 3 minor breathing incidents which was alleviated by using rescue inhaler(albuterol) Called in to Health Service and messaged primary care, was advised to take advil, tylenol, lots fluids and get tested for COVID19.
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| 61 | 2021-03-01 | joint pain |
The next day, when I woke up I was unable to stand on my left leg. Pain in the posterior knee. Felt ...
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The next day, when I woke up I was unable to stand on my left leg. Pain in the posterior knee. Felt like I was walking through mud. Joints were all loose. Just a really bad left knee pain. They a lower extremity doppler to that leg - to look for blood clot and that was negative. Physical therapy - taped my knee; pain was so bad I had to stay home a couple of times. My hands (both) were so painful. Like I had frostbite. Occupational therapy did hand massage and paraffin for the pain. And isotoner glove at night and that helps with the buzzing. I am 2 months out today from the vaccine and I'm starting to feel like normal. Took two months to fade away. It may have been because I was still having COVID antibodies. COVID antibodies on August started at 6.95. I'm not totally recovered right now but I'm close to normal. Doctor visit - January 29, 2021 and February 5, 2021.and February 19th. They put me on high dose of Steroids - 20 mgs Prednisone daily and another round of blood thinner -ELIQUIS mg which helped me with pain and joints.
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| 61 | 2021-03-01 | joint pain |
Moderate fatigue - unresolved mild headache - unresolved diarrhea - resolved 2/19/2021 joint pain - ...
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Moderate fatigue - unresolved mild headache - unresolved diarrhea - resolved 2/19/2021 joint pain - resolved 2/22/21 increased blood pressure - resolved 2/19/2021 swollen eye lids and upper checks - resolved 2/22/2021
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| 61 | 2021-03-01 | neck pain |
Severe neck soreness and tenderness 2/27 & 28, took Tylenol Rash& Itching at injection area. 2/27 4:...
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Severe neck soreness and tenderness 2/27 & 28, took Tylenol Rash& Itching at injection area. 2/27 4:00pm. Itching stopped 2/28 however the rash is still present on 3/2. Took Benadryl.
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| 61 | 2021-03-02 | muscular weakness, musculoskeletal discomfort, facial discomfort |
First headache, vertigo, dizziness, nausea, neck tension, left arm weakness. Progressed in the cours...
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First headache, vertigo, dizziness, nausea, neck tension, left arm weakness. Progressed in the course of several weeks to both legs weakness, and then the right arm, tension in the jaw and the face (altered facial sensation). Poor balance. Symptoms continue getting worse. Unable to work.
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| 61 | 2021-03-04 | muscle pain |
still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 wen...
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still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 went to get covid test but due to blood in my nose received antibody test which was neg; bad headache; winded; vomited; diaherra; coughing/cough; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on the left arm on 20Jan2021 18:45 at single dose for COVID-19 immunization. Medical history included diabetes mellitus and high BP from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, losartan potassium and sodium fluoride (CREST CAVITY PROTECTION). The patient previously took septra and experienced allergies. The patient reported that on 21Jan2021, they woke up and brushed their teeth then at 6:40am blood with large clots gushed from their right (rt) nostril. The patient went to ER and stopped bleeding after 2 hrs. On 22Jan2021, the patient woke up with bad headache, winded, vomited, diaherra (as reported), coughing. On 23Jan2021, they went to get covid test but due to blood in their nose, they received antibody test which was negative. On 24Jan2021, the patient was still feeling bad with all the above symptoms. Then on 25Jan2021, they went to ENT doctor who cauterized their nose and stated that since antibody was negative to take the maderna vaccine since they have no antibody in their system, the Pfizer vaccine did not work. From 26Jan2021 to 13Feb2021, the patient felt same started feeling better 14Feb2021 but still have sore muscles in their shoulders and cough. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 23Jan2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of epistaxis and clot blood which include the doctor cauterized their nose. The patient recovered with sequel from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the epistaxis and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including CBC and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 61 | 2021-03-06 | joint pain, muscle pain |
I have neuropathy symptoms, sore joints and muscles believed due to Tacrolimus. I see a neurologist ...
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I have neuropathy symptoms, sore joints and muscles believed due to Tacrolimus. I see a neurologist later this month. Following the first Covid vaccine, these symptoms increased. I was unsure whether this increase was due to the vaccine. However, following the second vaccine, my symptoms increased again and are substantially more severe than they were prior to the vaccine. I am also having increased pain in the area of my liver following both doses.
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| 61 | 2021-03-07 | limb discomfort |
110/68 97% pulse83 Left arm injection. Client reports heaviness in right arm pressure in her chest ...
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110/68 97% pulse83 Left arm injection. Client reports heaviness in right arm pressure in her chest almost immediate 10:10 108/68- pulse 96 pso2 97% right arm heaviness- chest pressure resolved. Client declined ER visit and requested to leave, spouse present will drive client home.
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| 61 | 2021-03-07 | muscle pain | swelling and muscle pain in rt arm |
| 61 | 2021-03-08 | limb discomfort |
Tongue swelled and then went numb - like novacaine had been shot into it, throat swelling by 6 PM, t...
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Tongue swelled and then went numb - like novacaine had been shot into it, throat swelling by 6 PM, took a big swig of Benadryl, went to Fire station, transported by ambulance to ER, blood pressure got way too low on ambulance ride, difficulty breathing/taking air in, IV applied - hospital by 6:30 PM, breathing still difficult, blood pressure better until it dropped again, IV given and monitored. Stable and discharged around midnight. Friday - Tuesday - very tired, heavy arms and legs, sore throat and tongue, limited to soft, bland. foods.
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| 61 | 2021-03-08 | musculoskeletal stiffness, joint pain |
I felt a shooting pain immediately from my arm into my shoulder area, and then felt itching and had ...
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I felt a shooting pain immediately from my arm into my shoulder area, and then felt itching and had a slight rash on chest area. When checked to be released, upon mentioning the rash, they checked my blood pressure, which is normally in the 90-100/68-70 range (low!) and it was 138/80. Sounds normal, but I?ve never had a blood pressure reading that high! I felt ok enough to leave with my husband, but later got dizzy, nauseous and throughout the day my joints (neck, shoulders, arms and legs) got increasingly painful, to the point where I could barely climb the stairs that night without assistance. Note: I run 5K every other day and bike or walk on off days, so I?m pretty active. I took Tylenol and went to bed early and was stiff, but better the next morning. Made myself get outside for a light run and was basically fine (albeit very tired) the next day. First day was a little scary though.
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| 61 | 2021-03-08 | rheumatoid arthritis, joint pain |
Unsure if this reaction could be Osteoarthritis because it is "symmetrical, definitely a trend of RA...
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Unsure if this reaction could be Osteoarthritis because it is "symmetrical, definitely a trend of RA"; Unsure if this reaction could be Osteoarthritis because it is "symmetrical, definitely a trend of RA"; Excruciating joint pain in my body; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 11Feb2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included Sjogren's autoimmune syndrome. The patient's concomitant medications were not reported. In Feb2021, the patient had excruciating joint pain in the body. The patient was unsure if the reaction could be osteoarthritis because it was "symmetrical, definitely a trend of RA". The outcome of the events, 'excruciating joint pain in the body', 'osteoarthritis' and 'RA', was unknown. The patient was due to receive the second dose of vaccination on 04Mar2021. Information about lot/batch number has been requested.
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| 61 | 2021-03-08 | rheumatoid arthritis, joint pain |
Day after 2nd vaccine had aching in all joints, chills with low fever, headache lasting 24-48 hours....
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Day after 2nd vaccine had aching in all joints, chills with low fever, headache lasting 24-48 hours. Hip pain continues worsening with walking and standing over time. Hips started to ache after first vaccine but didn't realize it was attributed to vaccine. Started taking fish oil and Glucosamine tabs for joints. Hip pain after 2nd vaccine increased and continues today. Went to Internal Medicine clinic to be seen on 1/25/2021. Xrays, UA, ANA, CBC and CMP were done. Xrays show mild degenerative changes to hips bilaterally. ANA elevated at 2.1. Everything else within normal limits. Physician then added RA, C- Reactive Protein and Sedrate, all coming back WNL. Will be making appointment with Rheumatoidologist.
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| 61 | 2021-03-09 | neck pain | Sore arm and neck muscles, headache, chills, and fatigue |
| 61 | 2021-03-10 | joint pain, musculoskeletal discomfort |
After 1st dose : Fatigue/tiredness/lack of energy for 1 day. After 2nd dose: Fever of 101 - 102.6...
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After 1st dose : Fatigue/tiredness/lack of energy for 1 day. After 2nd dose: Fever of 101 - 102.6 for 3 days. Hips achy. I have a total knee replacement of my R knee. That became warm to touch, painful and very stiff. The knee surgery was 3 years ago. I was prescribed MOBIC for the knee by my surgeon when I reported the issue.
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| 61 | 2021-03-10 | joint swelling, musculoskeletal stiffness, muscular weakness |
I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was...
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I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was as if the effects of my infusions were cancelled. Extreme widespread stiffness, pain, joint swelling and heat, muscle weakness and pain. I also had swollen lower lip and have had an increase in headaches and nausea. Two weeks after the injection I awoke with my right arm swollen, hard, and itchy. The arm and my lips have resolved, but I am still having all the other problems. I have reported these symptoms to both my primary doctor and my rheumatologist.
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| 61 | 2021-03-10 | muscle pain |
Begin 4 days after first vaccine on 3/9/2021- First significant increase in thirst; Extreme chills ...
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Begin 4 days after first vaccine on 3/9/2021- First significant increase in thirst; Extreme chills and fever rapidly spiking to 101.5; decrease to about 100 after a few hours and held steady through early morning; decreasing to my normal (97''s) next day; Significant headache from below forward head to left and right side of neck (eustachian tubes and mandibles and lymph nodes) eye pain; vomiting (limited); leg muscle pain/. No injection site reaction 3/11 feel great
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| 61 | 2021-03-11 | joint pain |
Already described people - excruciating pain in my right shoulder arm & elbow causing nausea. Shot g...
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Already described people - excruciating pain in my right shoulder arm & elbow causing nausea. Shot given in left arm. I?m at home so far nothing dead or hospitalized thank you
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| 61 | 2021-03-13 | muscle pain |
Around 12;00pm on 3/13 , I felt muscle aches through back, shoulders, neck. Sore at site of vaccin...
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Around 12;00pm on 3/13 , I felt muscle aches through back, shoulders, neck. Sore at site of vaccine and Headache. I felt tired and rested around 1:00p.m. Took 1 extra Strength Tylenol. Then started getting chills. Felt like I had swollen lymph node on ride side of throat when swallowing and had some pain going up into my ride ear. These symptoms lasted all evening. I didn't feel like eating dinner so rested and took 2 extra strength Tylenol at 9:00 p.m. and went to bed. Woke up early in morning with bad headache so I took another 2 extra strength Tylenol around 6:00am. I finally started feeling better around 9:00am.
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| 61 | 2021-03-14 | joint pain, muscle pain |
Pfizer-BioNTech COVID-19 Vaccine EUA. injection site pain, tiredness, headache, muscle pain, chills...
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Pfizer-BioNTech COVID-19 Vaccine EUA. injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell
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| 61 | 2021-03-14 | joint pain, neck pain, muscle pain |
Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and ...
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Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and neck and in my shoulders. I was not hungry and I had a fever(101.2). I slept until 1pm and I started getting nauseous. I never got up off the couch saturday. Pain in left arm/shoulder blade went away around 5pm Saturday. I still had a slight fever and headache saturday evening. Sunday I felt better but I still had a slight fever and headache but felt generally much better. Monday I had no fever no headache, and a little aching in my right arm at the injection site.
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| 61 | 2021-03-14 | joint pain |
Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and ho...
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Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and hot at injection site. All this started the day after injection .so severe that it felt like I had covid AGAIN! Couldnt eat or hardly get out of bed the day after shot and the second day after the shot I still felt the same but was able to eat . The third day after shot, my fever went away and most of the body aches except I still have the headache and my arm is still hot, and swollen. Just have been taking tylenol this whole time and cold wash cloth for fever and swelling.
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| 61 | 2021-03-14 | muscle pain |
Sore left upper arm by 5pm, 3-13-21. Very tired, muscular aches whole body, chills/feverish, headach...
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Sore left upper arm by 5pm, 3-13-21. Very tired, muscular aches whole body, chills/feverish, headache overnight to present, nausea. abdominal cramping and diarrhea x 2 days. Feels like 'the flu'.
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| 61 | 2021-03-15 | joint pain, back pain |
My joints swelled which includes knees, shoulders, severe pain in lower back, shoulders, knees. Coul...
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My joints swelled which includes knees, shoulders, severe pain in lower back, shoulders, knees. Couldn't do anything. It was a problem. Considered going to hospital for pain on second dose as i ran out of pain pills due to this episode
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| 61 | 2021-03-15 | joint pain |
nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; ...
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nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.
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| 61 | 2021-03-15 | musculoskeletal stiffness |
Within minutes of getting the shot in my left arm I started to feel the left side of my neck getting...
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Within minutes of getting the shot in my left arm I started to feel the left side of my neck getting stiff. It felt like the stiffness was creeping up my neck. After about a hour I felt my ear lobes tingling and the left side of my face in the jaw area seemed a bit swollen and felt a little numb. It resolved and I had only a sore injection site the next day and no other symptoms. I'm wondering if I should be concerned about getting the second shot
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| 61 | 2021-03-17 | muscle pain | Headache, chills, muscle soreness, pain at injection site, tired - still lingering |
| 61 | 2021-03-17 | muscle pain | Muscle pain in both upper legs |
| 61 | 2021-03-18 | joint pain |
I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by ...
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I had significant chills (causing strong body shaking) starting 3 hours after the shot, followed by 36 hours of intermittent fever combined with chills, fever was high but not measured. I was very weak and at times was unable to get out of bed or stand. I had significant joint and overall body pain, at times unable to stand up straight. As this subsided about 36 hours I remained quite weak. On the night of 16 March I was woken up at 1 am with a very severe headache. I took Tylenol and 5 hours later still had the headache - it subsided after about 8 hours. I additionally had stomach cramping but no vomiting or diarrhea, and had no bowel movements until the episode cleared up. During the 4 days that this occurred I tried to keep well hydrated but still had quite concentrated strong urine. I took Tylenol periodically throughout the 4 days, not starting until after the injection was administered. I still feel a little loss of balance/brain fog and have recurring headaches (not migranes).
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| 61 | 2021-03-18 | muscle pain | Fever, chills, muscle aches |
| 61 | 2021-03-18 | neck pain, joint pain |
At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV a...
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At about exactly 12 hours after receiving the vaccine. I was sitting in my living room watching TV and a sudden severe pain shot through my chest and followed by tightness and difficulty breathing. It was immediately accompanied by a pain between the shoulder blades, cold sweat, nausea, then neck pain and faintness along with the uncontrollable need to move my bowels which was in diarrhea form and continued 3 times within 20 minutes with the other symptoms. After about 5 minutes of receiving the onset of the initial shocking pain, the intensity of the chest pain left but the tightness remained and faded but would return and then subside again every 10 minutes. I went to the emergency room at 11:20pm discharged at 2:50am on 3/19/21.
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| 61 | 2021-03-19 | neck pain |
Around 7 hours after the shot the left side of my neck hurt a little along with a little sore throat...
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Around 7 hours after the shot the left side of my neck hurt a little along with a little sore throat. That evening, I was really tired with body aches. That night I had deep body aches and vomited. I also had a slight headache and coughing. The worst part was the extreme body aches. I felt like I had been hit by a truck. On Saturday (shot was on Thursday), I?m better but my body is sore and I don?t have much energy.
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| 61 | 2021-03-20 | joint pain, neck pain | Headache, shoulder and neck soreness, low grade fever-24 hours. Just tired today |
| 61 | 2021-03-20 | muscle pain |
Fever as high as 100.7, muscle aches, headache severe, fatigue moderate to severe, Three asthma att...
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Fever as high as 100.7, muscle aches, headache severe, fatigue moderate to severe, Three asthma attacks. One was severe taking 2 hours to resolve. Worse on 3/20 than today on 3/21. I?ve taken 2 Tylenol and used my rescue inhaler 4 times. The inhaler improves my breathing, but I don?t feel normal yet. Oxygen saturation between 93-96%. If still experiencing symptoms will call PCP and/or go to urgent care. If I?m still coughing I will have to reschedule a hematologist appointment.
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| 61 | 2021-03-20 | neck pain, muscle pain |
Severe headache; chills; muscle aches; arm and neck pain; arm and neck pain; This is a spontaneous r...
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Severe headache; chills; muscle aches; arm and neck pain; arm and neck pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN9581), via an unspecified route of administration, on 10Feb2021, 04:00PM as single dose in the right arm for COVID-19 immunization at Hospital. Medical history included gastroparesis, gastroesophageal reflux disease (GERD), memory loss. Allergies to medications, food, or other products was reported as yes. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient had been diagnosed with COVID-19. No other vaccines have been administered within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced severe headache, chills, muscle aches, arm and neck pain on 11Feb2021 12:00 PM. No treatment received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected
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| 61 | 2021-03-21 | joint pain, musculoskeletal discomfort |
States tenderness to top of left rib below arm pit that started around 2/24/21 and went to PCP on 3/...
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States tenderness to top of left rib below arm pit that started around 2/24/21 and went to PCP on 3/3/21 for evaluation. Reports bloodwork ordered. States she has been getting progressively worse with complaints of bilateral hip pain and discomfort to upper and lower back. Reports she had chills on 3/19/21 but no fever and has been in contact "daily" with PCP.
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| 61 | 2021-03-21 | joint pain |
16.5 hrs after injection stomach cramping and diarrhea every 2 hrs x 3. 24 hrs after injection chill...
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16.5 hrs after injection stomach cramping and diarrhea every 2 hrs x 3. 24 hrs after injection chills, fever (99.1), joint pain, fatigue.
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| 61 | 2021-03-21 | muscle tightness |
Patient reported to nurse after receiving first dose of Pfizer that 3-5 minutes later her left side ...
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Patient reported to nurse after receiving first dose of Pfizer that 3-5 minutes later her left side of neck/throat felt tight and tingled. Nurse alerted Doctor and myself to assist patient. We arrived to patient's car in front of garage at 10:55 AM and walked beside car as the husband pulled forward to park. Patient stated she received her vaccine about 10:45 and then as her husband started pulling forward, she told him about her symptoms. Dr. assessed patient and stayed with patient until 11:13AM. Patient left in passenger seat with her husband driving stating that she no longer felt the tightness in her neck or throat.
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| 61 | 2021-03-22 | joint pain, muscle pain |
Pfizer-BioNTech Covid 19 vaccine The night of the vaccine March 11th , I had fever of 100.8, chills,...
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Pfizer-BioNTech Covid 19 vaccine The night of the vaccine March 11th , I had fever of 100.8, chills, headache, muscle aches, sore throat, joint pain that lasted until Tuesday morning, March 16th. I had no symptoms on Tuesday & Wednesday, but developed hives on my ankles Thursday afternoon exactly one week after the Covid 19 vaccine. When I got up Friday morning I was covered in hives on my legs, arms and abdomen. The whelps were raised and itchy and appeared to be spreading. I went to my HCP and they administered an intramuscular steroid shot and advised me to take Benadryl as needed
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| 61 | 2021-03-22 | back pain |
After waiting 20 minutes, noted some back pain, tightness; on oxygen at home; cannister almost emp...
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After waiting 20 minutes, noted some back pain, tightness; on oxygen at home; cannister almost empty. VSS ; uncertain after called about whether to be evaluated/go home; refused ED at that time. Decided if could get in car comfortably would go home, if not, to ED for evaluation. More chest tightness as tried to get in car, decided to go to ED for evaluation; again called.
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| 61 | 2021-03-22 | muscle pain, joint pain |
Pfizer-BioNTECH Covid-19 Vaccine EUA Upper arm ?shoulder pain. Shaking chills, Body aches. Started a...
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Pfizer-BioNTECH Covid-19 Vaccine EUA Upper arm ?shoulder pain. Shaking chills, Body aches. Started at 1 a.m. on 3/23/2021. Tylenol 1000mg taken at 5a.m . Chills and muscle aches lasted until 12 noon. Deeling tired and very mild muscle aches continue. Tylenol 1000 mg taken at 4pm.
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| 61 | 2021-03-23 | joint pain, back pain |
BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; ...
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BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.
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| 61 | 2021-03-23 | muscle pain | dizziness, fatigue, severe stomach cramps and diarrhea, muscle aches 8 days running |
| 61 | 2021-03-23 | muscle pain |
I had swollen and very, very painful - the muscle on top of my shoulder (Trapezius) on the right sid...
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I had swollen and very, very painful - the muscle on top of my shoulder (Trapezius) on the right side and I took Advil late at night time because it was so painful I couldn't sleep. My arm was not sore but that muscle was. That seemed to calm it down (Advil). The next morning, I was very swollen under my right armpit - I figured it was my lymph node. It was uncomfortable and very noticeable - quite swollen for three days. It took about a week to go back to normal. I also had abnormal fatigue and that took longer to resolve - that took about two weeks to be resolved.
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| 61 | 2021-03-23 | neck pain |
I started developing painful nodules upper neck(right), around outside ear(sright) lower jaw line. B...
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I started developing painful nodules upper neck(right), around outside ear(sright) lower jaw line. Being a nurse I thought I was breaking out as the days went by I noticed it was Shingles.
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| 61 | 2021-03-24 | joint pain | Headache, body aches, joint pain, fever and excessive chills. |
| 61 | 2021-03-24 | joint pain | Injection site pain, tiredness, headache, chills, joint pain, fever |
| 61 | 2021-03-24 | joint pain |
On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 10...
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On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 102. On 3/22/21 and continue to have swelling in my left armpit (Lymph node area), spasms in my left shoulder blade and surrounding soft tissue adjacent to my left armpit and neck area. I have experienced soreness in that arm/shoulder but not at the injection site - overall bicep and clavicle area. I have been able to alleviate symptoms to a degree by taking a tylenol once or twice a day but the pain is limiting some of my daily activities to a degree.
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| 61 | 2021-03-24 | back pain |
Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tigh...
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Diabetes; unable to concentrate; arm is killing her; hands are swelled up; constipated; nausea; tightening of chest every so often; acid reflux; hot flashes; sweating; stomach aches; upper abdominal pain radiating to back; severe fatigue; Dizzy/dizziness; stomach feels odd; Headaches; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN6198), via an unspecified route of administration, administered in upper left arm on 25Feb2021 9:00 (at the age of 61-year-old) as single dose for virus (COVID-19 immunisation). Medical history included chronic pain, pancreatitis, allergic to medications, old injury in her right arm, menopause and an ongoing mass in parotid lobe discovered in 2019 with CT scan. MRI performed in Mar2020 and CT scan in Oct2020. She stated that they are just watching it because it has not changed. Well defined borders are present, caller stated that doctor was unconcerned. Her mother had heart disease. Ongoing concomitant medications included ibuprofen for chronic pain and gabapentin from 2019 for chronic pain. The patient also took unspecified medication for pancreatitis. She has taken all kinds of stuff after pancreatitis but they do not work. The patient got deadly ill from the flu shot. Unsure of onset age, vaccine/brand name, or vaccination date. She stated that it was before 2003, possibly in the late 1990's or early 2000's. The patient had no history of all previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the Pfizer suspect. On unspecified date the patient experienced diabetes; on 25Feb2021, the patient experienced dizzy, stomach feels odd, hot flashes, severe fatigue, sweating, stomach aches, acid reflux, upper abdominal pain radiating to back; on 26Feb2021 she experienced tightening of chest every so often; and in Feb2021, she had headache. It was further reported as follows: The patient stated that she took the Pfizer shot, clarified that she received the Covid-19 vaccine, on 25Feb2021, not quite 2 weeks ago. She stated that she had a little bit of a reaction after receiving the vaccination while there, so they were monitoring her. She has been experiencing hot flashes, sweating, and stomach aches for 2 days. She cannot get rid of hot flashes and that she has not had a hot flash in 2 years. She states that she has been down for 2 days with fatigue, that it's really bad. She is inquiring if the side effects that she is experiencing are common side effects and if it is ok to get 2nd shot. Her second vaccine is scheduled for 17Mar2021. She stated that she wanted to take the time to make a report as she is allergic to medications. While inquiring about dates of vaccines and side effects, she stated that she was experiencing tightening of chest every so often. She stated that she only had a few days of stomach pain and she has not stopped eating. She is unable to concentrate (unspecified date) and she has been experiencing headaches, experiencing them twice in 2 weeks. She also reported that she has been having upper abdominal pain radiating to her back. This concerns her, every time she gets it, it scares her. She had pancreatitis when she was 36. It is a nightmare thought. Does this sound like maybe she is possibly starting Diabetes? She reported that this shot has triggered everything. She has an old injury in her right arm. Her arm is killing her, her hands are swelled up, she has acid reflux again, she felt terrible. She stated that the dizziness not as strong as it was at the beginning. The fatigue it comes and goes and that she has spurts where she is energetic. She stated that it's more on than off. She is no longer having stomach aches. She compared the pain to pains of constipation. She also stated that she was constipated after receiving the vaccine on unspecified date. She had nausea at the beginning. The tightening of chest happened off and on, the last day that she experienced tightening of chest was on Sunday. For acid reflux, she is taking Zegerid as treatment, 20mg 20 mg capsules by mouth once daily as needed. She started this on 02Mar2021. She experienced upper abdominal pain yesterday and some this morning, but it was mostly in her back this morning. Her Sweating is off and on. She experienced headache just a couple of times but that she has not had one in a while. She stated that they lasted only an hour or two, and that she does not usually get headaches. She suggested that these may be due to sinuses and weather change. She has been taking Ibuprofen twice a day as treatment. But she normally takes Ibuprofen for chronic pain. Supposed to be 3 times a day but she does not want to take that much. She stated that all of this could also be stress related and that this could also be menopause. The patient recovered from stomach aches on 02Mar2021. The outcome of the events dizzy, sweating, tightening of chest every so often, upper abdominal pain radiating to back, headache was recovering; the outcome of stomach feels odd, hot flashes, severe fatigue, acid reflux was not recovered. The outcome of the remaining events was unknown.
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| 61 | 2021-03-25 | back pain, rheumatoid arthritis |
Rheumatoid arthritis/Rheumatoid arthritis attack; herpes outbreak- blisters in her mouth; wound on l...
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Rheumatoid arthritis/Rheumatoid arthritis attack; herpes outbreak- blisters in her mouth; wound on leg started to get worse, leaking a lot of fluid; back is hurting; felt like a tetanus shot in her arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EM9809), intramuscular in left arm on 10Feb2021 14:30 at single dose for covid-19 immunization. Medical history included high blood pressure, rheumatoid arthritis and kidney issues. Concomitant medication included insulin. The patient had the first COVID-19 vaccine. She had a lot of issues wrong with her, however she did not have them hit her at the same time. It was currently the 9th day since she had her first shot. About 4 or 5 days into it, the wound on her leg started to get worse. She had rheumatoid arthritis and she had an RA attack. She had herpes, but she did not had an outbreak in a couple of years. She got blisters in her mouth, and this also hit her. She explained everything hit her all at once. She was now on antibiotics for each one of the things. Her doctor figured out that her body just couldn't handle it. She clarified putting the vaccine into her body, she couldnt fight off everything. Like whatever in in the vaccine and how the vaccines works, her body was just not strong enough to fight off everything at the same time. The patient did not went to the emergency room. It was reported that the patient would receive her second dose on 03Mar2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 61 | 2021-03-25 | muscular weakness, musculoskeletal stiffness |
Sore arm for about 3 days. Then a week later I suddenly got cold hands, legs, stiff neck, swollen he...
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Sore arm for about 3 days. Then a week later I suddenly got cold hands, legs, stiff neck, swollen head, dizzy, multiple bowel movements, week leg muscles, tired. Lasted about 1 hour for initial wave, then was tired and out of commission for about 3 hours afterwards.
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| 61 | 2021-03-26 | muscle pain |
Tinnitus moderate to severe onset about 24 hours after vaccination. High pitched ringing both ears....
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Tinnitus moderate to severe onset about 24 hours after vaccination. High pitched ringing both ears. Occurred with a low grade fever, chills, and muscle aches. One alleve (naproxen sodium) pill to address symptoms did not impact tinnitus.
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| 61 | 2021-03-26 | neck pain |
Swelling of throat and neck pain, shortness of breath, headache progressed for 1 hour after shot. We...
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Swelling of throat and neck pain, shortness of breath, headache progressed for 1 hour after shot. Went to ER at Hospital. Took 25 mg Benedryl, declined prednisone, but left ER 2 hrs later with prescription for epipen and prednisone. Took Zytec at home and slept. Symptoms were gone next day.
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| 61 | 2021-03-27 | muscle pain, joint pain |
Injection site pain and redness, tiredness, splitting headache, muscle ache, chills, joint pain, in...
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Injection site pain and redness, tiredness, splitting headache, muscle ache, chills, joint pain, intermittent fever, loss of appetite
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| 61 | 2021-03-27 | muscle pain | Severe muscle pain in body Fever |
| 61 | 2021-03-29 | joint pain |
pain / swollen area where injection given. joint pain in every joint in my body - never had this bef...
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pain / swollen area where injection given. joint pain in every joint in my body - never had this before vaccine. Facial muscel spasms; both eyes and left side of cheek area. Never had this before.
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| 61 | 2021-03-29 | limb discomfort, joint pain |
Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt li...
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Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt like fire ants; chills; no energy; tightness in chest; This is a spontaneous report from a consumer reported for herself. An 61-year-old female non- pregnant is unknown female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration on Left arm on 02Feb2021 17:45 at single dose for covid-19 immunisation. Medical history included COVID-19, Congested Heart disease, and Penicillin allergy. The patient's concomitant medications were not reported. The patient experienced Hit with heaviness limbs pain in joints whelps all over body arms legs stomach back groin felt like fire ants chills no energy tightness in chest on 22Feb2021. Received Inhalers for breathing and steroids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Recovering".
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| 61 | 2021-03-30 | armpit pain |
Uncontrollable chills for 4 hours until I fell asleep followed the next day by painful swelling unde...
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Uncontrollable chills for 4 hours until I fell asleep followed the next day by painful swelling under the left arm.
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| 61 | 2021-03-30 | muscular weakness, musculoskeletal discomfort, neck pain, limb discomfort |
Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and ...
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Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.
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| 61 | 2021-03-30 | muscle pain, joint pain |
Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appet...
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Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible, No further information available
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| 61 | 2021-03-30 | muscle pain |
chills; injection site pain; headache; muscle pain; fever/tiny fever; impacted lymph nodes/lymph nod...
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chills; injection site pain; headache; muscle pain; fever/tiny fever; impacted lymph nodes/lymph nodes are impacted a little bit; nausea/feeling nauseous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6206) via an unspecified route of administration, administered in Arm Left (left shoulder), at the age of 61-year-old, on 03Mar2021 19:00, as SINGLE DOSE for covid-19 immunisation. The patient medical history was overweight, diagnosed COVID last Apr2020 she had it for 17 days and had every symptoms. The patient tried to give antibodies for many months and she was told she had two different kinds of antibodies which prevented her from doing that. The patient has long hauler symptoms which are nerve pain in her thighs and mouth. The patient's concomitant included an unspecified medication (she takes something but not relevant). The patient did not receive any vaccine within 4 weeks prior. The patient previously received shingles vaccine on 14Feb2020 and tetanus shot on an unspecified date (years ago) both given for immunization and her arm hurt/ pain at the injection site (if she touches it, it hurts). On 03Mar2021 at 7PM, after receiving first dose, she felt blah described as she developed injection site pain which is dissipating but still there, headache, muscle pain, tiny fever, impacted lymph nodes, nausea/ feeling nauseous which she didn't have before. The patient can get up and walk around. On 04Mar2021, the patient had chills in the afternoon. It was just a little fever. The patient took Tylenol and Advil in the afternoon and it helped it go away. The patient took one of each. It was reported that the COVID headache is like none other and she had the headache again. For the COVID headache if you take things it doesn't make it go away. When the patient said she had the headache again she meant she had the same headache that she had in April. The events did not require ER or physician office visit. Outcome of injection site pain was not recovered while it was unknown for the other events. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
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| 61 | 2021-03-31 | armpit pain |
Swelling/discomfort in armpit of arm corresponding with covid vaccine injection. Although swelling...
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Swelling/discomfort in armpit of arm corresponding with covid vaccine injection. Although swelling/discomfort continues, it is lessening with time.
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| 61 | 2021-03-31 | back pain | severe back pain - cramping and spasms; treated with ice and ibuprofen |
| 61 | 2021-03-31 | limb discomfort |
felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quen...
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felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient). The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization. Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.
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| 61 | 2021-03-31 | muscle pain |
Immediate strong metallic taste that has not gone away. High fevers 103, chills and shaking, fatigu...
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Immediate strong metallic taste that has not gone away. High fevers 103, chills and shaking, fatigue, muscle aches and nausea.
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| 61 | 2021-04-01 | joint pain |
on 4/1/2021 my left clavicle was very sore. then noticed it was swollen - looks like lymph nodes. ...
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on 4/1/2021 my left clavicle was very sore. then noticed it was swollen - looks like lymph nodes. praying & hoping it will go away. other than that, slight headache nite of shot & day after (4/1) was also extremely tired. i did have the covid on 12/9 & it turned into pneumonia.
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| 61 | 2021-04-01 | musculoskeletal stiffness |
Stiff arm today. However, patient received second Pfizer COVID vaccine 14 days after first dose inst...
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Stiff arm today. However, patient received second Pfizer COVID vaccine 14 days after first dose instead of 21 days after first dose.
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| 61 | 2021-04-01 | neck pain |
Dizziness, nausea, sleepiness, fog brain, temperature of 96-96,4 (taken with more than one thermomet...
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Dizziness, nausea, sleepiness, fog brain, temperature of 96-96,4 (taken with more than one thermometer), throbbing pain in left arm traveling to neck.
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| 61 | 2021-04-01 | rheumatoid arthritis |
rheumatoid arthritis which has flared up following vaccination.; This is a spontaneous report receiv...
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rheumatoid arthritis which has flared up following vaccination.; This is a spontaneous report received from a contactable nurse (patient). A 61-year-old female patient received BNT162B2 (Pfizer BioNTech COVID-19 vaccine, Formulation: Solution for injection (batch/Lot number: unknown), via an unspecified route of administration on 26Feb2021 at single dose for COVID-19 immunization. Medical history included blindness. Concomitant medications was not reported. Her next dose was in 2 days. The patient reported that she was ok the first few days after vaccination then experienced side effects including joint pains, the patient had numerous autoimmune diseases, specifying one of the as rheumatoid arthritis which has flared up following vaccination. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of RA flare due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 61 | 2021-04-02 | muscle pain, joint pain |
feels tired; muscle ache; joint ache; fever (up to 100F).; This is a spontaneous report from a conta...
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feels tired; muscle ache; joint ache; fever (up to 100F).; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 61-years, at single dose on 22Mar2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she received first dose of pfizer covid vaccine yesterday (on 22Mar2021). Today (on 23Mar2021), she felt tired, muscle ache, joint ache and fever (up to 100F). The patient underwent lab tests and procedures which included body temperature was up to 100F on 23Mar2021. Events outcome was unknown. Information on the lot/ batch number has been requested.
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| 61 | 2021-04-03 | muscle pain |
ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joi...
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ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joint stiffness; nausea; sharp pains in stomach and breasts; sharp pains in stomach and breasts; tightness in chest; fatigue; dizziness; impaired mental clarity; 102 fever/99 degree fever; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 15Mar2021 at 18:00 (06:00 PM) (Batch/Lot Number: EN6208) at the age of 61-years-old as single dose for COVID-19 immunization; administered to the patient in public health clinic/administration facility. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient's medical history included known allergies (unspecified). The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in the left arm on 22Feb2021 at 07:30 PM (lot number: EL9266) at the age of 61-years-old for COVID-19 immunization. The patient experienced 102 fever the night of 16Mar2021 (also reported as 16Mar2021 at 06:00 AM) with chills, muscle aches and weakness, joint stiffness, nausea, sharp pains in stomach and breasts, tightness in chest, fatigue, dizziness, and impaired mental clarity. On 17Mar2021, the patient experienced ears plugged and ringing, weakness, tongue sore, and impaired mental clarity. The patient had 99 degree fever during the nights of 17Mar2021 and 18Mar2021 thus far. The patient did not receive treatment for the events. The patient has not been tested for COVID post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).
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| 61 | 2021-04-10 | limb discomfort, muscular weakness |
I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood press...
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I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood pressure is usually very well controlled. On Monday the 29th, at about 3:30 pm, I started to slur my words. At first we blamed it on the Novocaiine earlier in the day, but I had been talking fine after it and had had it many, many times before and it was worn off. We called my doctor's office after my right arm and leg became very heavy and awkward. They told me to go to the nearest hospital. When I got there, I presented ass a full stroke. I was very hard to understand and my mouth drooped and I had very little use of my right arm and leg. They ran tests, but could not give me the medication because I was already on Eliquis. They thought they saw a small clot very high up. I was hospitalized over the next four days and improved my speech dramatically after a bad headache on March 30. The doctors go back and forth to whether it was a Acute Ischemic Stroke, which is what my paperwork says and a complex migraine. I do not experience migraines or anything like this ever before. I did not have a real headache on the 29th. Since my symptoms, right arm and leg difficulties are still here, my Doctor believes it was a stroke. I have an appointment with a Neurologist and I have to have another MRI. I am going to Physical Therapy. My Doctor told me to fill this out, she thinks it may be from the vaccine.
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| 61 | 2021-04-12 | limb discomfort, joint pain |
very mild tremor in my right index finger/ finger underwent stronger and more pronounced tremors/the...
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very mild tremor in my right index finger/ finger underwent stronger and more pronounced tremors/the neuropathy was more pronounced; an increase in foot spasms; discomfort in my feet concurrent with an improvement in sensation in my arches; a bit more stiffness and achiness in my knees; have noticed an increase in foot spasms and discomfort in my feet concurrent with an improvement in sensation in my arches; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN), via an unspecified route of administration on 04Mar2021 as single dose for covid-19 immunization. Patient relevant medical history included diagnosed with breast cancer three years ago and have some chemo-induced peripheral neuropathy in her hands and feet. The patient's concomitant medications were not reported. Since getting her first shot on March 4, patient have noticed an increase in foot spasms and discomfort in her feet concurrent with an improvement in sensation in her arches. She also had several instances of a brief, very mild tremor in my right index finger, which was where most of the residual neuropathy in her hand resides; when the neuropathy was more pronounced, that finger underwent stronger and more pronounced tremors, whereas what patient had this month is negligible. Patient also had a bit more stiffness and achiness in her knees (both of which have recovered from traumatic injuries), which had mostly leveled off before my second shot but then regained some severity after the second, which was on March 23. (Yes, a 19-day cycle my shots were administered by Hospital. It was unknown if the patient received any treatment for the reported adverse event or not. It was unknown that patient was tested for COVID-19 after the vaccination or not. The outcome of the events was unknown. Information about on Lot/Batch number has been requested.
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| 61 | 2021-04-13 | muscle pain |
Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills...
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Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.
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| 61 | 2021-04-14 | joint pain | Error: Shoulder Joint Injury (prolonged pain, tingling, etc.) |
| 61 | 2021-04-16 | muscle pain |
test positive for COVID 19; test positive for COVID 19; coughing; Muscle aches; Fatigue; Sore throat...
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test positive for COVID 19; test positive for COVID 19; coughing; Muscle aches; Fatigue; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 16Jan2021 10:30 as single dose for covid-19 immunisation. Medical history included high blood pressure, migraines, inflammatory arthritis, penicillin allergy. Concomitant medications included eszopiclone (LUNESTA) (MANUFACTURER UNKNOWN); valsartan (MANUFACTURER UNKNOWN); sumatriptan succinate (IMITREX) (MANUFACTURER UNKNOWN). On 8Feb2021, the patient experienced coughing, muscle aches, fatigue, sore throat. On 23Feb2021, the patient experienced test positive for covid 19. There was no direct adverse reaction from the vaccine, but I did test positive for COVID 19 on 23Feb2021 (yesterday) with symptoms of coughing, muscle aches, fatigue and sore throat. The patient underwent lab tests which included sars-cov-2 test: negative on 19Feb2021 and sars-cov-2 test: positive on 23Feb2021. The patient did not receive any treatment for the events. The clinical outcomes of the coughing, muscle aches, fatigue, sore throat, test positive for covid 19. No follow-up attempts are possible.
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| 61 | 2021-04-17 | back pain |
This is a spontaneous report from received from contactable consumer. A 61-year-old female patient r...
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This is a spontaneous report from received from contactable consumer. A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7534), via an unspecified route of administration on 24Mar2021 via an unspecified route of administration in top of left arm as single dose for covid-19 immunization. Medical history included Salpingo-oophorectomy (resection to remove an ovary and fallopian tube) in Mar2016 and an operation in 2016 for diverticulitis. Concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. No, she says this is her first vaccine, she has never even had the flu vaccine. Caller clarifies she is talking about the Pfizer BioNTech vaccine. Later in the call clarified as the COVID-19 vaccination. She is calling to report that she contracted COVID. She says she is so discouraged, she did everything right and she ended up getting COVID, she was shot in the arm, her family forced her to get it, 7 days later she was sick, so sick Wednesday(31Mar2021)/Thursday(01Apr2021), positive on Saturday (03Apr2021). She says she is been googling this, it has only been only 6 months, less than 6 months in. On 30 Mar2021, patient had experienced ill, Sneezing, coughing, choking, coughing up phlegm, Fever, Chills and aches. Patient says she did not get her second shot, she is supposed to go for it on 14Apr2021 but she suspects she had to get tested before she gets the vaccine. She says she does not know what to do. She says she is isolating herself and has her own bathroom. She says her card has a patient number and an ISS number. She says she is got this vaccine for society to get this vaccine rolling so we can be whatever the word is, for social status, to be in the cool club. Patient says she had no tests since she does not have a primary. The adverse event was not resulted in emergency room. The patient was resolving from the event COVID. At the time of reporting the outcome of the events were unknown. Additional information has been requested.
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| 61 | 2021-04-18 | back pain, joint pain |
Severe left chest back and shoulder pain lasting more than 2 days; Severe left chest back and should...
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Severe left chest back and shoulder pain lasting more than 2 days; Severe left chest back and shoulder pain lasting more than 2 days; Severe left chest back and shoulder pain lasting more than 2 days; high BP; fluid around heart; elevated D DIM; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer BioNTech, lot: EN6199) in left arm on 06Apr2021 06:30 PM at a single dose for COVID-19 immunization. Facility type vaccine was Pharmacy or Drug Store. Medical history was not reported. Patient was not pregnant (AS REPORTED) at the time of vaccination. Concomitant medications were unspecified. No other vaccine in four weeks. Other medications in two weeks was yes. Patient used to receive Wellbutrin and experienced allergies. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: ER8733) in left arm on 17Mar2021 05:00 PM at a single dose for COVID-19 immunization. Patient experienced severe left chest back and shoulder pain lasting more than 2 days accompanied by high blood pressure (BP), fluid around heart and elevated D DIM on 07Apr2021 05:30 AM. Adverse events (AE) resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The outcome of the events was recovering. AE treatment: Ultrasound, CT Scan, morphine. If COVID prior vaccination was no. If COVID tested post vaccination was no.
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| 61 | 2021-04-18 | muscular weakness, joint pain |
having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, lef...
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having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.
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| 61 | 2021-04-20 | neck pain |
severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started...
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severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started swelling; rapid breathing, couldn't control her breathing; heart rate it got faster; started getting confused; shaky; wheezing; swelling of her throat; blood pressure dropped; This is a spontaneous report form a contactable consumer reporting for herself. A 61 years old female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; NDC number 59267-1000-01) on 29Mar2921 at 14:15, in left upper arm, for COVID-19 immunisation. No other vaccines were given on the same date or within 4 weeks. Medical history included allergic to hamsters (she found out that this one had the Chinese Hamster Ovary cells and she knew she had problems with those things), allergic to prednisone (crazy rash, itching), allergic to a lot of different things, sinus infection. Family history included allergy (the whole family had allergies). Concomitant medications included unspecified antibiotics for sinus infection (but it had cleared up by then) and unspecified allergy shots (but not a vaccine). The patient just wanted to report that she had a severe allergic reaction to the vaccine on 29Mar2021. Symptoms began minutes after getting vaccine. The patient experienced getting lots of saliva started with a couple of minutes of getting the shot, tongue started swelling, rapid breathing, couldn't control her breathing, heart rate it got faster, started getting confused, shaky, wheezing, swelling of her throat, blood pressure dropped, all on 29Mar2021. On 30Mar2021 the patient experienced sore arm and neck pain but she thought that was more of a vaccination saying it was working. Clinical course of the events included the following information: the patient had to stay for a while since she had allergies normally. She started getting lots of saliva and she thought that was her body saying, she did something, not a big deal. Around 15 minutes, she was at a grocery store, she started walking around, her tongue started swelling, rapid breathing, she couldn't control her breathing and heart rate, it got faster. She started getting confused, shaky, it wasn't too good. She made her way back to the place where the injections were done, they were trying to get her to use her epinephrine (EPIPEN). She took a diphenidramine (BENADRYL) while walking around looking for her husband and then took another and was wheezing. She thought BENADRYL would have helped. She should have taken her EPIPEN looking back, she thought BENADRYL would help. They heard wheezing, they contacted the other pharmacist, who contacted EMS then they came and took her to the emergency room on 29Mar2021 in the afternoon. When she was wheeled in, the doctor met her in the hall and he said they could give her a steroid shot. The patient stated she was allergic to prednisone, she got a crazy rash, itching, it's not just prednisone, it's an allergy. She got the shot at 14:15 and she was at the hospital by 15:00. The patient thought she was there for 5 hours and then she was sent home. Her blood pressure dropped. The only one she saw was 114/39 but her husband saw it went even lower than that. At the emergency room, they had the automatic thing strapped on so they watched her until it started going back up again. The vaccine shot was probably the easiest shot she had ever had. She had never had any problems. She did not research it very well in the beginning because she thought they should be good. The patient was told to not get the second vaccine. The events also required physician office visit. Allergic reaction symptoms resolved on 29Mar2021 but the swelling of her throat and heart rate lasted about four days, until 02Apr2021. Neck pain resolved on 01Apr2021. Sore arm resolved on 03Apr2021 or 04Apr2021. Blood pressure dropping resolved on an unspecified date in 2021. Information on the lot/batch number has been requested.
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| 61 | 2021-04-21 | muscle pain |
After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the ...
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After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the arm. Throughout the day and into the night I had pain, redness, itching and swelling at injection site. The next day (21st) a hard lump developed under the skin where I had the injection. I also had a headache and muscle aches. I didn't take any medication for the pain and discomfort as I was told it was beneficial to let the reactions occur without drug interaction or interference.
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| 61 | 2021-04-23 | neck pain |
Sore arm and neck on the injection side of body.; Sore arm and neck on the injection side of body.; ...
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Sore arm and neck on the injection side of body.; Sore arm and neck on the injection side of body.; This is a spontaneous report from a contactable Other HCP. A 61-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9261), dose 1 via an unspecified route of administration, in left arm on 07Feb2021 13:30 (at 61-years age) as single dose for covid-19 immunisation. Medical history included diabetes, hypertension, obesity, arthritis, copd and patient was allergic to bactrin, perfume. Concomitant medication(s) included doxepin (DOXEPIN); dapagliflozin propanediol monohydrate (FARXIGA); metformin (METFORMIN); temazepam (TEMAZEPAM); dulaglutide (TRULICITY). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.on 08Feb2021 04:00, The patient experienced sore arm and neck on the injection side of body.No treatment received for reported adverse event. The outcome of the event was resolved.
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| 61 | 2021-04-24 | muscular weakness |
she could have partially had a stroke; She woke up and her left hand and arm were numb; left arm hur...
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she could have partially had a stroke; She woke up and her left hand and arm were numb; left arm hurts a couple of days ago; Her hand is now cramped up, and she cannot bend it, almost like someone who has cerebral palsy.; she could not use her left hand; Her hand is now cramped up, and she can not bend it, almost like someone who has cerebral palsy./all her fingers are cramped and she cant open them and her hand is in a brace; radial nerve palsy; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6198) via an unspecified route of administration, administration in left arm on 19Mar2021 as SINGLE DOSE for covid-19 immunization. Medical history was not reported. There were no concomitant medications. On 01Apr2021, she woke up and her left hand and arm were numb. She went to the hospital, and they told her she could have partially and had a stroke. Three days after receiving the first dose of the Covid vaccine, she could not use her left hand. Her hand was now cramped up, and she could not bend it, almost like someone who had cerebral palsy. She stated that after the first dose her left hand went numb, and she went to the hospital and was diagnosed with radial nerve palsy. She stated that all her fingers are cramped, and she can't open them, and her hand was in a brace. She stated that she would have to do physical therapy. It was her left hand, the same arm that she got the first dose of the Covid vaccine in. She could not move her left hand. She was really annoyed about it, and she was scared. The patient stated that she had a grandson and a daughter. This vaccine was the best possible way to prevent Covid. She had always got vaccines. Upon follow-up received on 09Apr2021, she was calling about the Pfizer Covid vaccine. She does not have a ride to get her second dose of the Covid vaccine on Saturday morning. She does not know the name of the facility where she was supposed to go. She was asking for help with an (cab service). She thought she was calling her county. She would call her county and ask for help with a ride. She had a reaction after her first dose of the Covid vaccine. She received the first dose on 19Mar2021. She does not know if it was because of the Covid vaccine. She was asking if she should get the second dose of the Covid vaccine in the same arm as last time. She wanted to get the second dose of the Covid vaccine in the same arm as last time, so that she does not mess up the other side of her body. She was asking what was going on with her arm. She was asking if thaws had anything to do with the Covid vaccine. Upon follow-up received on 09Apr2021, she scheduled second dose due on 10Apr. Her left arm hurts a couple of days ago, it ended her going to the hospital. She called to ask if it had something to do with the Covid vaccine. The event hypoaesthesia, cerebral palsy, muscular weakness, muscle spasms outcome was reported as not recovered. The event cerebrovascular accident, pain in extremity, radial nerve palsy outcome was reported as Unknown. The action taken in response to the events for bnt162b2 was not applicable. Therapeutic measures were taken as a result of her hand was now cramped up, and she cannot bend it, almost like someone who had cerebral palsy. (cerebral palsy). Follow-up (09Apr2021): This follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that: New significant information.
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| 61 | 2021-04-28 | joint pain |
passed out; tunnel vision; "jerking movements" of her upper extremities; left arm was tingling/left ...
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passed out; tunnel vision; "jerking movements" of her upper extremities; left arm was tingling/left pinky and ring fingers felt nerve tingling sensations; then the back of her throat had a chemical taste and tingling; then the back of her throat had a chemical taste and tingling; BP was 164/94 while lying down; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; tongue was tingling and felt swollen with an altered chemical taste for 2 days; tongue was tingling and felt swollen with an altered chemical taste for 2 days; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 11:00 (Lot Number: ER8734) at the age of 61 years old as single dose for covid-19 immunisation. Medical history included Low thyroid, kidney infections, skin rashes, high cholesterol, food sensitivities. Concomitant medications in two weeks included liothyronine sodium (CYTOMEL); levothyroxine; vitamin b complex (VITAMIN B); levoglutamide (L GLUTAMINE). Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. On 12Apr2021 11:00, within 1st min of vaccine, the patient's left arm was tingling, then the back of her throat had a chemical taste and tingling, then tunnel vision, then that was the last thing she remembered until she heard her partner saying, "Are you ok?" The patient said to her she thought she fell asleep. She was an RN and said that the patient passed out for about 15 seconds and had "jerking movements" of her upper extremities before she woke up. The staff and medic helped the patient to the floor where she rested for 20 min with her legs elevated on chair. BP was 164/94 while lying down, pulse was 74. The patient returned home and continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder for most of the day. Also her left pinky and ring fingers felt nerve tingling sensations for the rest of the day. Her tongue was tingling and felt swollen with an altered chemical taste for 2 days. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.
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| 61 | 2021-04-28 | muscle pain | Fever, muscle ache, headache, extreme fatigue |
| 61 | 2021-05-05 | muscle pain |
Cough; Shortness of Breath; Fatigue, Chills, Muscle or Body Aches, Headaches, New loss of taste or s...
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Cough; Shortness of Breath; Fatigue, Chills, Muscle or Body Aches, Headaches, New loss of taste or smell, Congestion or Runny Nose, Diarrhea; Vomiting. Prednisone (DELTASONE) 10 mg tablet; Take 2 tablets (20 mg total) by mouth 2 (two) times a day for 4 days-Azithromycin (ZITHROMAX) 250 mg tablet; z pack. 500 mg day one 250 mg day 2-5. -Albuterol HFA (PROVENTIL;VENTOLIN) 90 mcg/actuation inhaler; Inhale 2 puffs every 6 (six) hours as needed for wheezing for up to 7 days.
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| 61 | 2021-05-07 | back pain |
Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the bac...
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Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.
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| 61 | 2021-05-09 | joint pain, musculoskeletal discomfort |
Lower back discomfort/mild joint pain Mild injection site pain Large swelling/redness at site for a ...
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Lower back discomfort/mild joint pain Mild injection site pain Large swelling/redness at site for a week Mild/moderate loss of bladder control Vertigo/nausea Lethargy Chills/fever 102.9 Congestion/cough Headache Unwell for about 24 hours
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| 61 | 2021-05-09 | back pain |
Mild/moderate loss of bladder control Off balance Injection site pain Headache/ stabbing pain in lef...
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Mild/moderate loss of bladder control Off balance Injection site pain Headache/ stabbing pain in left temple area,a little in the right temple/"spacey" feeling Lower back pain/General muscle weakness Chills/ low grade fever Nausea Congestion/cough Lasted 24-48 hours
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| 61 | 2021-05-09 | flank pain | pain in side, blood clots in lung |
| 61 | 2021-05-10 | joint pain, limb discomfort, neck pain |
bled a bit; pain in left finger joints/ joint aches; sudden heaviness in arm; chills; severe fatigue...
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bled a bit; pain in left finger joints/ joint aches; sudden heaviness in arm; chills; severe fatigue; over all unwell/uneasy feeling; Nausea started about the 5th hour; feeling feverish, but never had a real fever; odd little pains in the left side of her neck; tension type headache; foggy; blood vein and possibly a nerve was hit; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9265) at 10:00 at single dose for COVID-19 immunisation. The relevant medical history included arthritis, breathing issues - asthma/copd still being tested, hypertension, liver issues and known allergies: Ct contrast, Dilaudid, Flagyl combined with doxycyline or cephlexinc. Concomitant medications were reported as none. At injection, a blood vein and possibly a nerve was hit. She felt the nurse followed all proper protocol for finishing the injection and notifying RN in charge. On 03Feb2021 at 2:00 PM, the patient had immediate pain in left finger joints and sudden heaviness in arm within a couple of minutes. It bled a bit. She was still having some issues with the hand, but the injection site was fine. She was concerned about the number of symptoms, the severeness and the length of time they had lasted. This was very worrisome and unexpected from all other accounts by others and everything she had read on the first vaccine. She was feeling 'off' within 2 hours, by the 4th hour She had developed chills, severe fatigue and over all unwell/uneasy feeling. Nausea started about the 5th hour and she started feeling feverish, but never had a real fever, odd little pains in the left side of her neck, but that subsided. Developed tension type headache, joint aches, foggy. This continued for about 4 1/2 days. Unable to function without Tylenol every 5hr. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
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| 62 | 2021-01-02 | muscle pain |
9 DAYS POST VACCINATION EXPERIENCED SORE THROAT, MILD DRY COUGH, CHILLS W/O FEVER, GENERALIZED FLU L...
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9 DAYS POST VACCINATION EXPERIENCED SORE THROAT, MILD DRY COUGH, CHILLS W/O FEVER, GENERALIZED FLU LIKE MUSCLE ACHES.
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| 62 | 2021-01-02 | neck pain, back pain, muscle pain |
Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours l...
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Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours later with severe back pain, neck pain, deep muscle ache in legs, low grade fever. 24 hours after injection, some decrease in pain with Tylenol, diarrhea, fatigue, general malaise. Loss of taste, loss of appetite . 48 hours post injection- subsiding muscle aches, other symptoms on going, 72 hours post to present, diarrhea, loss of appetite
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| 62 | 2021-01-03 | back pain |
Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe ...
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Arm was sore for about three days. On 12/21 evening, had headache, some lightheadedness and severe back muscle ache. On 12/22, had stomach upset, extreme fatigue, nasal congestion. On 12/24, had diarrhea. Fatigue continued until at least 12/29.
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| 62 | 2021-01-03 | muscle pain, joint pain | Severe joint and muscle pain of entire body 9 days after vaccination |
| 62 | 2021-01-04 | musculoskeletal stiffness, neck pain |
Left deltoid was sore initially, then pain progressed upward into left neck up to just under left ea...
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Left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear; Left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear; Also felt a little stiffness in that neck area; This is a spontaneous report from a contactable nurse, the patient. A 62-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EH9899) via an unspecified route of administration, in the left arm, on 19Dec2020 at 07:00 AM (at the age of 62-year-old) as a single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included fish oil (OMEGA 3 FISH OIL), calcium carbonate, colecalciferol (VITAMIN D 2000). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Dec2020, at 08:00 AM, the patient experienced left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear, she also felt a little stiffness in that neck area. The neck pain lasted 24 hours. The events were reported as non-serious. The patient did not receive any treatment for left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear, she also felt a little stiffness in that neck area. The clinical outcome of the events left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear, she also felt a little stiffness in that neck area was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 62 | 2021-01-05 | joint pain |
swelling and joint pain in the little finger on left arm; swelling and joint pain in the little fing...
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swelling and joint pain in the little finger on left arm; swelling and joint pain in the little finger on left arm; She got a bruise at the injection site; It bled a little bit when she put it in; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231), via an unspecified route of administration on the left arm, on 28Dec2020 at 14:15 at a single dose for Covid-19 immunization. Medical history included environmental allergies, she has allergies and can have an asthmatic attack from cat dander and perfume, blood pressure (abnormal) and sleep (disorder). Concomitant medications included ongoing lisinopril for blood pressure, colecalciferol (VITAMIN D), acetylsalicylic acid (BABY ASPIRIN), paracetamol (TYLENOL). The patient previously took novocaine but was allergic. She got all this information when she got the vaccine on Monday at (place name) in (state name). It tells all the side effects from the first injection. She wanted to report that it is the same arm that she got the vaccine in. She has swelling and joint pain in the little finger on left arm. It says you can have joint pain, but nothing about swelling. She thought she better report it. This was her first shot. She is supposed to get the second one on 18Jan2021. She wanted to make sure she can take it. She received the vaccine on 28Dec2020. She laid around that day. Today is the first day she doesn't have arm pain and swelling at the injection site. It was the first time she has had arm pain. She has never had that with flu shot. The arm pain started within the 15 minutes she was observed. It hurt like hell until that day. She got a bruise at the injection site. It bled a little bit when she put it in. Swelling and joint pain in the little finger on left arm: she doesn't know if it was later that day. She can't remember. She really noticed it yesterday. She has never had joint pain or swelling. She doesn't have any problems with arthritis. Now her little finger is bigger than the rest of her fingers. It hurts because of the swelling. She doesn't want to take anything. It might be fluid. She has a high pain tolerance. She keeps bending it thinking it will get better. It isn't as bad, but its still swelled up. At first she thought it was better, but it is still pretty swollen. To her this is a reaction. She was thinking if she took paracetamol before, it wouldn't hurt as bad, but she can't remember if she took it that morning. She takes 500mg before bed for the heck of it at night. It helps her sleep better. She has allergies and can have an asthmatic attack from cat dander and perfume. They think she was allergic to the preservative in the flu shot, but she has never had any trouble with the flu shot since. She has environmental allergies. They thought she was allergic to Novocaine once at the dentist office. Who knows, it only happened once. She's been to the dentist many times and who knows what they injected and why she reacted that way. She felt like she was going to pass out. They don't give it to her anymore. She doesn't know what was in it. She is worried since this vaccine is emergency authorization. She doesn't want to get the next one and have a worse reaction. She is not sure if she should be worried. The events of swelling and joint pain in the little finger on left arm were assessed as medically significant. Outcome of the event of 'swelling of fingers' was not recovered, the other events were unknown.; Sender's Comments: There is a reasonable possibility that the event joint pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the event swelling with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-01-05 | joint pain |
1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white no...
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1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white noise in ears, fatigue lacinating pain ankles, knees ,wrist and finger joints; pain along nerves and vessels fingers with right fourth DIP ulnar side small vessel bleed hematoma 4 cm x 4cm swelling; NO trauma sedenatry Saw Urgent care 1/4/21 -with negative covid 19, strep and flu tests said was repsonse to vaccine Saw primary 1/5/21 Dr hopsital, said probably had covid before and was repsonse to vaccine. 1/6/21; all fingers still swollen no pain most other symptoms improving but TIRED
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| 62 | 2021-01-05 | muscle pain |
Feeling unwell; Headache; Tiredness; Muscle pain; Chills; Nausea; Injection site pain; had been asle...
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Feeling unwell; Headache; Tiredness; Muscle pain; Chills; Nausea; Injection site pain; had been asleep most of the whole day; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: Arp2021), via an unspecified route of administration on 30Dec2020 at single dose at right arm for Covid virus. Medical history included blood thinner treatment. Concomitant medication included ongoing apixaban (ELIQUIS) for blood thinner treatment. The patient previously took coumadin, warfarin. Patient received the Covid-19 vaccine yesterday. She had been asleep most of the whole day (Dec2020). She had injection site pain, headache, tiredness, muscle pain and chills. She thought she was going to work but that didn't work. She was currently taking Eliquis. She had been on coumadin and warfarin before. She looked at the different medications that needed to be reported. She would also call her physician and make her aware. The start date for "Injection site pain" was 30Dec2020. The start dates for headache, tiredness, muscle pain and chills all were 31Dec2020. The patient also experienced nausea, feeling unwell on 31Dec2020. Investigation assessment was no. The outcome of the event "Injection site pain" was not recovered. The outcome of the other events was unknown.
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| 62 | 2021-01-06 | musculoskeletal stiffness | Very sore arm, unable to lift or move, stiff neck |
| 62 | 2021-01-06 | muscle pain, joint pain | chills, fever, joint pain, muscle aches |
| 62 | 2021-01-07 | joint pain, muscle pain |
Fine pin point rash and itching noted 45 minutes after shot given. Rash noted to neck,spine,hips,upp...
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Fine pin point rash and itching noted 45 minutes after shot given. Rash noted to neck,spine,hips,upper back,upper chest and bend of both arms.Benadryl 25 mg OTC 1/6/21 and 1/7/21.Itching. Itching decreasing 1/8/21. Having copious side effects also of injection site pain,tiredness,headache,joint and muscle pain,nausea,lymphadenopathy and feeling unwell.1/6/21,1/7/21 but feeing better when tylenol 500mg ing system to relieve aches and pains
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| 62 | 2021-01-07 | joint pain, muscle pain | chills, fever, muscle ache, joint pain |
| 62 | 2021-01-07 | back pain, muscle pain, muscular weakness, joint swelling |
Pfizer-BioTech COVID-19 Vaccine EUA 24 hrs post vaccination I started feeling fatigued, muscle and h...
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Pfizer-BioTech COVID-19 Vaccine EUA 24 hrs post vaccination I started feeling fatigued, muscle and headaches which seemed to move around my body for about 24 hrs. At one point it seemed to settle into my hand. Knuckles swelled arthritis like. When walking up stairs I had significant muscle weakness in my legs and exertional dyspnea. Eyes felt "feverish" but had no fever. The next morning while trying to do a routine workout the same thing happened. It was a significant change to my normal condition. The dyspnea was the most concerning. The body aches settled into my lower back. Fatigue was moderate-moderately severe. As the day went on things waxed and waned. By the end of 72 hrs. most symptoms subsided. Friday 01/08/2021 I had a completely normal workout, no exertional dyspnea, fatigue subsided, no body aches. Back to normal. I would consider the symptoms to have been Moderate+.
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| 62 | 2021-01-07 | musculoskeletal stiffness, back pain, muscle tightness |
Back pain; Muscles felt really tightened up and stiff when getting out of bed and throughout the day...
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Back pain; Muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint); slight nausea/nausea; slight fatigue; slight headache; slightly stiff neck; right arm pain; The muscles knot up under her rib cage/muscle tightness; This is a spontaneous report from a contactable other health care professional. A 62-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), intramuscularly in the left arm on 29Dec2020 at 06:30 at a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis from an unknown date and unknown if ongoing. Concomitant medications included ergocalciferol (VIT D), levothyroxine (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unspecified date to an unspecified date. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergy from an unspecified date to an unspecified date, influenza vaccine (FLU VACCINE) for an immunization on an unspecified date (received within two weeks of vaccination). The patient experienced the following events and outcomes: muscles felt really tightened up and stiff when getting out of bed and throughout the day (worst complaint) (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight nausea/nausea (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight fatigue (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slight headache (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, slightly stiff neck (non-serious) on 30Dec2020 at 07:00 with outcome of not recovered, right arm pain (non-serious) on 30Dec2020 with outcome of unknown, back pain (non-serious) on 31Dec2020 with outcome of unknown, the muscles knot up under her rib cage/muscle tightness (non-serious) in Dec2020 with outcome of unknown. The patient received the COVID-19 vaccine on 29Dec2020 at work, and she had been experiencing adverse events since. The worst side effect she was experiencing was muscle tightness. At the time of the report, the patient got up at 09:00, and her "back was killing her." The patient was achy. The patient would tighten up really tight under both rib cages, and it made her nauseous. The patient had been taking ibuprofen (ADVIL) and ibuprofen (MANUFACTURER UNKNOWN since she received the vaccination. The patient received the vaccine in her left arm, but her right arm hurt the next day. The next day after that (30Dec2020) she woke up and the right side of her back around the kidney area hurt. It was the right side lumbar. The next morning after that, "her entire back was killing her down the middle of her spine. From her head all the way down." Since then, it came and went. The patient could not say if it was persisting, improving or worsening for any of the symptoms. "It just grabs her." The day before the report, the patient thought she was doing better. The patient cleaned the house, and then sat down to eat. The past two nights, it had "hit her really hard during supper time." Both of her sides of her back would tighten up; "tense up like waiting for an impact before a wreck." The patient's back would seize up. The patient could not get comfortable; and would start pacing. Then, she would try to lay down. Last night, it took a half an hour to loosen back up. "It knots up like crazy. It was bad enough, she thought she was going to pass out." The patient did not know if it was the combination of eating supper or what. The patient thought if she got up that maybe she would feel better. The patient started pacing around. The patient went outside because she thought maybe fresh air would help. When it would tighten up under her rib cage, it made her nauseous. The patient did not know if it was a "vagus nerve thing or what." The patient was close to throwing up. The muscles knot up under her rib cage. The patient's back felt like she fell off a horse. It was weird to her that her left arm never bothered her. "Nothing stays the same." Sometimes it was her entire arm or part of the arm that hurt. Like on top of her forearm. The patient thought she was doing good and then it would come back. When she moved her arm upward, she felt it. The patient said she could deal with the arm pain. It was the knotting up pains that were the worst. The patient tried calling an institute (name withheld) because it happened while eating dinner the other night. The institute (name withheld) "nurse was useless." The pain was across her sacroiliac area. The patient had been "living on Advil and ibuprofen for her back pain." The patient had been taking them together. The patient worked nights, and she was planning on going to work the night before the report, but she had to text her boss and tell her she could not come in. The patient was in good health; had perfect blood pressure and her sugar was normal. The patient was not diabetic. The patient's labs were always normal. The patient was really dreading that second shot. "The flu shot kicked her butt for a couple of days, but this was way worse." The patient started reading up on the COVID vaccine, and it said usually younger people had severe side effects. That old people have less of a response. The patient did not know why she was experiencing such side effects. At the time of the report, it was day 7 or 8, and she was still feeling bad. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 62 | 2021-01-07 | musculoskeletal stiffness |
Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm. She ha...
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Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm. She has not had history of reaction before. Starting from midnight that night she has fever between 100.6-101.2, body aches and stiff neck. She also has swollen left arm pit, head ache, Pruritus breathing. She has a history of afib and last night she had two runs of it and took metoprolol.
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| 62 | 2021-01-07 | muscle pain | Chills, headache, muscle pain, tiredness, and nausea. |
| 62 | 2021-01-07 | muscle pain | Headache, Myalgia chills |
| 62 | 2021-01-07 | neck pain, back pain |
Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore th...
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Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Tested Positive for COVID-19/nausea, occasional dry cough, neck and lower back soreness, and sore throat; Weakness/generalized weakness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162b2 (Pfizer, Lot number: 5730), via an unspecified route of administration at right arm at 22Dec2020 21:00 at single dose for covid-19 immunization. Medical history included Mayonaise allergies. The patient's concomitant medications were not reported. The patient previously took codeine and experienced allergies. At 31Dec2020 06:00, the patient experienced Weakness, nausea, occasional dry cough, generalized weakness, neck and lower back soreness, and sore throat which has now dissipated. Tested Positive for COVID-19 on 02Jan2021 (also reported as 01Jan2021, pending clarification). The covid test type post vaccination was Nasal Swab, Covid test name post vaccination was COVID-19 PCR ROCHE c6800(NTX), RNA SARS CoV2 TGT1, PAN SARS RNA TGT2. No treatment received for events. The events result in Emergency room/department or urgent care. The patient was not pregnant. The outcome of the events were nor recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.
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| 62 | 2021-01-08 | muscle pain | Fever, chills, muscle aches, headache |
| 62 | 2021-01-08 | muscle pain | Myalgia, NauseaVomiting, chills |
| 62 | 2021-01-08 | muscle pain |
Confusion, Headache, Myalgia, fatigue, chills Narrative: Felt "loopy" with sharp vision initially....
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Confusion, Headache, Myalgia, fatigue, chills Narrative: Felt "loopy" with sharp vision initially. Over 3 day period developed varying degrees of chills, headache, muscle aches. Fatigue on first day.
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| 62 | 2021-01-09 | neck pain, joint pain |
Early morning Friday 01/08/21, moderate pain at injection site, PO Tylenol 1000mg, @ 0615, heading i...
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Early morning Friday 01/08/21, moderate pain at injection site, PO Tylenol 1000mg, @ 0615, heading into work. Then @ 1030 feeling tired, neck & shoulder pain, chills, headache, right ear pain, slight sore throat, PO Motrin, 400mg moderate relief. Total of 30 hrs of recurring symptoms, alternating Tylenol & Motrin throughout. Started to feel better Saturday afternoon 4-4:30p
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| 62 | 2021-01-10 | armpit pain | swelling in left axilla pain in L axilla |
| 62 | 2021-01-10 | muscle pain |
Eight hours after vaccine I developed terrible chills fever, terrible myalgia and weakness . The ...
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Eight hours after vaccine I developed terrible chills fever, terrible myalgia and weakness . The pain was terrible as was the fatigue and fever . I used Ibuprofen. 48 hours later I felt almost completely normal- no pain etc . Then 56 hours later resumption of chills fever for 4 hours . At 64 hours and after ibuprofen feeling better
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| 62 | 2021-01-10 | neck pain |
Patient's reaction(s) noted during COVID vaccine observation period: Pain on left side of neck (same...
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Patient's reaction(s) noted during COVID vaccine observation period: Pain on left side of neck (same side as injection site) ) and waves of nausea. Actions Taken: VS taken and WNL. Pt states the nausea is resolving and she feels comfortable just going home.
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| 62 | 2021-01-11 | joint pain |
Chills, dizzy (nearly fainted), headache and joint (hip) pain. All symptoms manifested approximately...
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Chills, dizzy (nearly fainted), headache and joint (hip) pain. All symptoms manifested approximately 21 hours after injection
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| 62 | 2021-01-11 | limb discomfort |
pateint received vaccine and about 15 minutes later felt a heaviness in her arm and some pins and ne...
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pateint received vaccine and about 15 minutes later felt a heaviness in her arm and some pins and needles sensation in hand, arm and left leg. NO rash, no itching, no notable other side effects; denies palipations, shortness of breath, no pain , no hives, no cough or swelling
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| 62 | 2021-01-11 | musculoskeletal discomfort |
some congestion that just came on; her arm was really aching after the injection; she started coughi...
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some congestion that just came on; her arm was really aching after the injection; she started coughing; voice was hoarse; light wheeze; soles of her feet were hurting; pressure in bilateral groin; aching all over; very tired; balance issues; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231) intramuscularly in left upper arm on 05Jan2021 at single dose for covid-19 immunisation. The patient got her Covid vaccine yesterday (05Jan2021) around 11 or 11:30 am in her left upper arm. She had bilateral breast cancer and had lymph nodes removed in each arm but more removed from her Right, so she got the vaccine in the left arm. She also had some skin cancers removed, one would not heal properly on her left arm and formed a blister, and her dermatologist popped it and put a band aid on it. The vaccine was given 3 inches above it. The patient's concomitant medications were not reported. The patient experienced pressure in bilateral groin, aching all over, very tired and balance issues on 05Jan2021; light wheeze on 06Jan2021. Seriousness for these events was medically significant. The patient stated she had some congestion that just came on. She felt fine yesterday (05Jan2021) right after getting the vaccine, that at work she did notice that there was something different feeling in the left side of her groin. She was not in direct patient care. She noticed on her left side in the groin, something felt different, then yesterday evening (05Jan2021) after work she was really tired in the evening, aching all over last night, even the soles of her feet were hurting, woke up like her balance was off, she would walk one way and go another, states it is not like an orthostatic issue, that she knows what that feels like. She stated that in her inguinal area she could feel pressure, bilaterally. Her arm was really aching after the injection. Her breathing, heard a light wheezing, was clearing her voice, and then she started coughing, voice was hoarse. The outcome of events pressure in bilateral groin, very tired and light wheeze was not recovered; of events aching all over and balance issues was recovering; of other events was unknown.; Sender's Comments: The reported events bilateral groin, aching all over, very tired, balance issues and light wheeze were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 62 | 2021-01-11 | muscle pain |
About 10:30 pm, 1/11/21, became very cold teeth chattering headache, sharp pains in muscles then ach...
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About 10:30 pm, 1/11/21, became very cold teeth chattering headache, sharp pains in muscles then aches, uncomfortable to touch skin. Took 2 acetaminophen, lots of blankets, able to sleep. No fever, woke up with same symptoms but milder.
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| 62 | 2021-01-12 | joint pain | Fever. Chills. Headache. All my joints hurt. |
| 62 | 2021-01-12 | muscle pain | Chills, fever, severe muscle aches, headache, fatigue |
| 62 | 2021-01-13 | joint pain |
Body aches; fever; chills; diarrhea; headache; joint pain; nausea; fatigue; This is a spontaneous re...
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Body aches; fever; chills; diarrhea; headache; joint pain; nausea; fatigue; This is a spontaneous report from a contactable other HCP (patient). This 62--year-old female HCP reported for herself received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via intramuscular route of administration, on 07Jan2021at 02:00 PM (at the age of 62 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included chronic Fatigue. The patient have known allergies to Sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included liothyronine sodium (T3), levothyroxine sodium (T4), progesterone, estradiol, estriol (BIESTROGEN), testosterone, colecalciferol (VITAMIN D), calcium, zinc sulfate (XINC), ascorbic acid (Vitamin C), magnesium. The patient previously received the first dose of BNT162B2 (lot number/expiration date: unknown) on 17Dec2020 at 10:30 AM (at the age of 62 years old) as a single dose in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 10:00 PM, after the second dose, the patient experienced body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue. No treatment was received for the events body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue. The outcome of the events body aches, fever, chills, diarrhea, headache, joint pain, nausea, fatigue was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 62 | 2021-01-13 | musculoskeletal stiffness |
Almost immediately after the injection, I noticed a metallic taste. It was mild enough that it did n...
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Almost immediately after the injection, I noticed a metallic taste. It was mild enough that it did not interfere with the taste of foods or drinks. It was noticeable whenever I had not had anything by mouth for a while. This lasted for 2 to 3, maybe 4, days. Soreness at the injection site, and stiffness of the arm, began the evening after the injection. Warming applications and moving the arm relieved these symptoms. They were gone the next day.
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| 62 | 2021-01-14 | armpit pain | body aches, chills, cough, headache, nausea--soreness/swelling left armpit |
| 62 | 2021-01-14 | back pain, joint pain |
Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. ...
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Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. Within minutes her tongue was tingling with sensation of feeling full-felt funny. 30 min later had frontal/jaw headache. 60 min later chills with goose bumps all over while working (works as resp technician at NMCP). While walking to car, her upper arm and front of thighs hurt as if exercised too much. Self treated with Advil and tylenol. --- Next day 1/12 0100am awoke with severe bilateral shoulder joint pain extending to shoulder blades, stabbing abdominal/stomach pain, nausea, urge to vomit. she returned to sleep but awoke 6am with nausea and severe diarrhea and fatigue. She c/o nasal congetion, sinus fullness and severe post nasal drip x 24 hours. S/s persisted and left work early now with severe bilateral ankle pain. She was off Wed/Thursday. Wed 1/13 her shoulder pains eased but now with severe back pain. Wed evening noted tongue swelling sensation again (has pictures) and took oral benadryl and ice chips. She went to sleep. Thursday 1/14 bilateral knee pain/joint with increased nausea again - treated with zofran. Friday 1/15 returned to work, pain in knees made gait wobbly = treated with advil. Notified ID MD and director on tongue swelling and constantly trying to clear throat = sent to ER where treated with oral decadron and M Toradol for pain. She was sent home with prednisone dose pack and compazine. Recommended f/u with HCP for further testing to r/o possibility of a mast cell disorder of familial hypertrytassemia due to her history of multiple allergies/insect allergies--
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| 62 | 2021-01-14 | muscle pain |
Second dose of Pfizer vaccine was administered too early, at day 15. Individual is reporting muscle...
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Second dose of Pfizer vaccine was administered too early, at day 15. Individual is reporting muscle pain, fever, and headache
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| 62 | 2021-01-14 | muscle pain |
2nd dose next day had nausea in am since subsided. chills muscle aches and swelling soreness at arm ...
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2nd dose next day had nausea in am since subsided. chills muscle aches and swelling soreness at arm site present @ this time.
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| 62 | 2021-01-15 | muscle pain |
Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = ...
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Jan 12, 11:30am - Dizziness, headache, muscle aches, weakness, cold feeling, flushed. Temperature = 102.4 F. Had to leave work. Slept for 18 hours, Symptoms continued for 48 hours.
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| 62 | 2021-01-17 | back pain |
Feel like , I have a cold or allergies, Lower back pain, Abdominal Pain One Knee was shaking right a...
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Feel like , I have a cold or allergies, Lower back pain, Abdominal Pain One Knee was shaking right after vaccine Full body pain daily mostly in the lower back
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| 62 | 2021-01-17 | neck pain, joint pain |
Left arm sore 2 days, 3rd day left neck, shoulder, arm , shoulder blade pain. Symptoms have not reso...
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Left arm sore 2 days, 3rd day left neck, shoulder, arm , shoulder blade pain. Symptoms have not resolved 1/18/2021, not as painful now advil and massage therapist therapist treatment
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| 62 | 2021-01-17 | neck pain |
I had my first vaccination on 1/11/21 at HD. The reaction was typical- significantly sore red inflam...
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I had my first vaccination on 1/11/21 at HD. The reaction was typical- significantly sore red inflammed arm over deltoid muscle that resolved after 3 days. Second dose given 21 days later- some swelling and soreness, low grade fever. Then 3 days later, I awoke, turned in bed and experienced an intense shearing pain in my neck and arm. The pain was the worst ever felt, and was not improved with NSAIDS, Acetaminophen, Hydrocodone, or Tramadol. I went to an urgent care center on 1/16 where a tentative diagnosis of sprained neck was made. The sypmptoms continue with slight improvement with steroids, and a muscle relaxant. I am concerned because I understand that covid itself can impact the nervous system considerably. I am awaiting improvement in symptoms and if none seen then I will see my primary care MD
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| 62 | 2021-01-18 | joint pain | Severe headache joint pain about 12-14 hts |
| 62 | 2021-01-18 | muscle pain, musculoskeletal stiffness |
Pfizer -BioNTech Covid-19 Vaccine EUA After the vaccine I developed headache, low grade fever, muscl...
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Pfizer -BioNTech Covid-19 Vaccine EUA After the vaccine I developed headache, low grade fever, muscle ache, stiffness and nausea. This felt positive for the first 3 days until the symptoms did not leave and remained for 9 days post vaccination.
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| 62 | 2021-01-20 | muscle pain, joint pain |
fever of 100.5; severe muscle and joint aches for about 24 hours; severe muscle and joint aches for ...
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fever of 100.5; severe muscle and joint aches for about 24 hours; severe muscle and joint aches for about 24 hours; severe headache; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: E11283), via an unspecified route of administration on 07Jan2021 06:30 at a single dose for covid-19 immunization. The patient's medical history included osteoarthritis from an unknown date and unknown if ongoing. Concomitant medication included aciclovir sodium (ACYCLOVIR [ACICLOVIR SODIUM]), famotidine (FAMOTIDINE), hydroxychloroquine (HYDROXYCHLOROQUINE), escitalopram oxalate (LEXAPRO), rosuvastatin calcium (ROSUVAST) , cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took cipro [ciprofloxacin hydrochloride monohydrate] and experienced drug hypersensitivity, vioxx and experienced drug hypersensitivity, ees and experienced drug hypersensitivity. On 07Jan2021 at 18:30, 12 hours after the injection, the patient experienced fever of 100.5 with severe muscle and joint aches for about 24 hours. Then the fever subsided and had severe headache for 24 hours. All the events recovered in Jan2021.
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| 62 | 2021-01-20 | weight decreased |
Bruise in arm; I lost some weight; This is a spontaneous report from a contactable Consumer. This co...
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Bruise in arm; I lost some weight; This is a spontaneous report from a contactable Consumer. This consumer reported for herself that the 62-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on unknown date at a single dose for covid-19 immunisation. Medical history included "I went to the doctor because I wasn't feeling well just little congestion inside my lungs." Concomitant medications included "Yes, Antibiotics, I was worried I didn't think about it since I think about it yesterday, wow is this going to effect the vaccine (further not clarified)." Consumer stated, "I have a question I received the First shot (clarified as Covid 19 vaccine) here 20th of this month I get my second but 7th of this month I didn't even think about it I went to the doctors even though I was negative and they put me on antibiotics is that going to interfere with the vaccine. Consumer stated, "I guess no, I had no side effects, I got a bruise in my arm and that was all." Consumer stated, "120 pounds, I lost some weight." Consumer stated, "I just had my blood count checked that's all." The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 62 | 2021-01-21 | bone pain |
Pain in all over bones started at 11pm continued all over 24 hours. Bilateral arms still painfull fo...
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Pain in all over bones started at 11pm continued all over 24 hours. Bilateral arms still painfull for 48 hours. Took extra strength tylenol and advil did not help very much.
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| 62 | 2021-01-23 | joint pain |
Starting on the 16th of Jan I became very sick to my stomach.This lasted the the AM on the 18th no o...
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Starting on the 16th of Jan I became very sick to my stomach.This lasted the the AM on the 18th no other syptoms present. I left work at 8:00am on the 18th with no fever ( I checked three times during the midnight shift ) I went home to bed and woke up at 6:00pm with 100.8 fever ( I never run a fever ) had fever chills and joint pain in the upper body no respiratory issues .Within 48 hours the fever was gone as well as the chills but I continued to be sick to my stomach for another two days.I wanted to report this delayed reaction because of my underlying HIV and given the fact no individuals with HIV were included in the initial study. I tested negative with the nasal swab test on the 20th.
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| 62 | 2021-01-24 | joint pain, musculoskeletal chest pain |
joint pain; bad back spasms in the middle of the back radiating up through right should to right arm...
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joint pain; bad back spasms in the middle of the back radiating up through right should to right arm; Sweating; arm pain; she couldn't do anything with her right hand. She "couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing".; arm shoulder blade rib cage are sore; arm shoulder blade rib cage are sore; This is a spontaneous report from a contactable consumer (patient, healthcare tech in the ER). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Jan2021 at single dose for COVID-19 immunization. Medical history included spondylosis. Concomitant medications were not reported. patient calls today to report symptoms following administration of the covid vaccine. Caller reports that she got the vaccine on Friday. Reports that on Saturday she started to have joint pain everywhere on Sunday she felt a little better. Reports that on Monday she got up and had really bad back spasms in the middle of the back radiating up through right should to right arm. She went to work, only worked for 2 hours and then checked into the ED. They did an EKG because she was sweating and was with arm pain. They did X-rays and gave her steroids and gave her a pain shot stating it didn't do anything, states they put her on steroids to come home with, muscle relaxers to stop spams. Reports that on Monday night she couldn't do anything with her right hand. She couldn't open a soda can, the next morning couldn't get socks on, hand wouldn't work, and had a difficult time writing or typing. The spasms won't stop, everything; arm shoulder blade rib cage was sore. Went back to the ER on Tuesday, they did a thoracic and cervical MRI, nothing looked different or wrong. they told her to stay on steroids and keep taking muscle relaxers, with ibuprofen and Tylenol. She also asks, what should her do, and if her history of spondylosis triggering this reaction. Patient was recovering from joint pain, was not recovered from bad back spasms in the middle of the back radiating up through right should to right arm and arm shoulder blade rib cage are sore. Outcome of the events was unknown. Identification of the case safety report serious was No. Information on the Lot/Batch number has been requested.
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| 62 | 2021-01-24 | joint pain |
Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; ...
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Brain fog; headache; Muscle spasm at injection site; Severe fatigue; joint pain; Driving difficult; Swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date not reported), via an unspecified route of administration in the left arm on 08Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included latex allergy. Concomitant medications included ibuprofen and paracetamol (TYLENOL). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: Ek5730, expiry date not reported) in the right arm on 18Dec2020 15:00 at single dose for COVID-19 immunisation. On 08Jan2021 at 18:00, the patient experienced brain fog, headache, muscle spasm at injection site, severe fatigue, joint pain, driving difficult and swelling. It was unknown if treatment was received for the adverse events. Clinical outcome of the events was not recovered.
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| 62 | 2021-01-24 | joint pain |
arm soreness, joint pain, chills, fatigue x 48 hours headache start at same time but has gotten wo...
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arm soreness, joint pain, chills, fatigue x 48 hours headache start at same time but has gotten worse on day 3 post vaccine and not relieved by acetaminophen
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| 62 | 2021-01-24 | joint pain | Pain and very tender to touch in left clavicle area. |
| 62 | 2021-01-24 | joint pain |
Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulenc...
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Unable to get out of bed: She is so sleepy and has no energy; Wiped out of energy; lots of flatulence; Chills; Joint pain; Lower GI symptoms; she is also feeling cold; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: GL3248 (Caller said that the G may be an E.)), via an unspecified route of administration in the left arm on 07Jan2021 at second single dose for working with cancer patients. Medical history included ongoing diabetic and ongoing hyperthyroidism, both diagnosed about 6 years ago and were under control. There were no concomitant medications. Historical vaccine included BNT162B2 on 18Dec2020 for working with cancer patients (First dose, lot number: EJ1685, injection in the left arm). On 11Jan2021 the patient had chills, joint pain, and lower GI symptoms. Her lower GI symptoms included diarrhea. Then caller clarified that it was not diarrhea but the urge to go. The stools were solid. She also had lots of flatulence. She was also wiped out of energy, around like 2 PM on 11Jan2021 she went up a flight of stairs and was so exhausted. The patient is a nurse. She was in her office that day and had to literally lay on the floor because she was so wiped out of energy. She left work early and went to bed. Then the next day 12Jan2021, she was unable to get out of bed the whole day. She is so sleepy and has no energy. She went to bed last night at 08:30, but is still so sleepy. Today she is feeling better, but still had lower GI symptoms. She was also feeling cold, which she normally is always hot. She was having to put 5 blankets on her. Outcome of the event chills was recovered on 12Jan2021, of events joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed was recovering, of events flatulence and feeling cold was unknown. The reporter considered the event chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed as serious (disability) and related to BNT162B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported chills, joint pain, lower GI symptoms, wiped out of energy, unable to get out of bed and the administration of the COVID 19 vaccine, BNT162B2, given the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 62 | 2021-01-24 | joint pain |
1/14 am. General malaise and fever shortn of breath, cough sneezing body?s aches joint pain ongoing...
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1/14 am. General malaise and fever shortn of breath, cough sneezing body?s aches joint pain ongoing for last 10 days Still low grade fever 99.8 and cough headache body aches weakness fatigue short of breath
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| 62 | 2021-01-24 | neck pain | neck pain that ran up to head |
| 62 | 2021-01-24 | neck pain |
Within 10 min after injection had pain in left side of neck and jaw. was given 800mg Ibuprofen and t...
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Within 10 min after injection had pain in left side of neck and jaw. was given 800mg Ibuprofen and took for a few days. On Jan 6, 2021 supraclavicular swelling occurred near base of neck size of a baseball and lt neck pain. Saw physician on 1/8/21 and have soft tissue swelling
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| 62 | 2021-01-25 | armpit pain |
Patient self-reported to the hospital's electronic ADR reporting system. In her own word, "After 2...
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Patient self-reported to the hospital's electronic ADR reporting system. In her own word, "After 2nd dose of Pfizer COVID-19 Vaccine 1/15/21, the injection site became swollen , itchy, and painful. The following day, under my armpit was swollen and painful. This lasted for 5 days".
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| 62 | 2021-01-26 | joint pain | bil arm pain, bil wrist pain, mild joint pain |
| 62 | 2021-01-27 | limb discomfort |
Vaccine given high up on shoulder, not 3 finger widths down. Persistent pain right shoulder and uppe...
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Vaccine given high up on shoulder, not 3 finger widths down. Persistent pain right shoulder and upper arm, positional discomfort. Pocket of fluid accumulation above right clavicle.
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| 62 | 2021-01-27 | musculoskeletal discomfort, limb discomfort |
Persistent shoulder and upper arm discomfort. Positional discomfort, pocket of fluid above right cla...
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Persistent shoulder and upper arm discomfort. Positional discomfort, pocket of fluid above right clavicle. I believe injection was given improperly, too high up on shoulder, not 3 finger widths down.
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| 62 | 2021-01-27 | muscle pain |
migraines; arm is sore where the injection; she could hear like blood going through her, and if she ...
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migraines; arm is sore where the injection; she could hear like blood going through her, and if she moved it got faster and faster; Chills; muscle aches; not feeling well; Headache; fever; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 21Dec2020 by injection once to right arm (Lot Number: EJ1685) at SINGLE DOSE, via an unspecified route of administration on 11Jan2021 (Lot Number: EL3302) at SINGLE DOSE for covid-19 immunization (reported as healthcare worker, medical receptionist). Medical history included Other Conditions No. There were no concomitant medications. The patient experienced fever on 11Jan2021, headache on 12Jan2021, chills on 12Jan2021 23:30 , muscle aches on 12Jan2021 06:00, not feeling well on 12Jan2021 , migraines and arm is sore where the injection on an unspecified date. The caller had her second vaccine (later clarified as COVID vaccine) on 11Jan2021, and had the same symptoms as on the first one. They were not as bad, and she thought the first one was pretty bad. She previously reported her symptoms with the first vaccine. Symptoms with the second were fever, headache, chills, of course, and muscle aches, her arm weighs a ton, and not feeling well. Fever was noted when she was sleeping, it is now 99.6, but it was was 103. Headache was noted in the early morning, it was not a normal headache, it was the worst thing, and she is prone to migraines, but this was not even like that, she could hear like blood going through her, and if she moved it got faster and faster, one time, she stood still and it was like ahhh! Chills started about 11:30 last night, they went away this morning, about 11AM. Muscle aches started at 6AM yesterday, and are finally gone, as of probably about 9AM, they are fine now, just her arm is sore where the injection was. Not feeling well started yesterday and is getting better. First dose was 21Dec2020, she previously provided lot EJ1685, confirms both were Pfizer vaccines. The outcome of the event fever, not feeling well was recovering, headache recovered on 13Jan2021, chills recovered on 13Jan2021 11:00, muscle aches recovered on 13Jan2021 09:00. No follow-up attempts possible. No further information expected.
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| 62 | 2021-01-29 | joint pain, muscle pain | injection side pain, tiredness, headache, muscle pain, chills, joint pain, fever |
| 62 | 2021-01-30 | joint pain, muscle pain |
Early afternoon - Tiredness- 7-8 pm Fever of 99; Muscle/joint aches/pains; Upset stomach; stuff nose...
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Early afternoon - Tiredness- 7-8 pm Fever of 99; Muscle/joint aches/pains; Upset stomach; stuff nose Later in evening - hives Next morning - swollen lip on left side (had derm filler on 1/21/2021) Took Tylenol and Benadryl
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| 62 | 2021-01-30 | joint pain | Chills with uncontrollable shivering, headache, body aches and joint pain |
| 62 | 2021-01-31 | muscular weakness, joint pain |
(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point...
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(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point pupils, unable to talk, headache, facial and lip numbness, numbness traveled down the right side of my body (side of injection) trembles, weak legs, very weak all over. EMTs were called but I didn't go to the hospital. My son picked me up and took me home because I was unable to drive. On the way I experienced loss of vision and speech for about 5 minutes. When I got home, my legs were so shaky that I had to have help walking. I started getting severe chills that took 3 hours to get warm (2 heavy blankets, space heater, and heating pad). I was very fatigued and felt bad the rest of the day. (Saturday)The next day I had flu-like symptoms; headache, joint aches, chills, nausea, extreme fatigue. Sunday was better but still had to rest most of the day because when I would stay up for over 30 minutes, the symptoms would return. Monday- stomach cramps, headache, fatigue but went to work (30 minutes late due to stomach) and left 30 minutes early.
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| 62 | 2021-02-01 | muscle pain | Severe site pain and muscle aches |
| 62 | 2021-02-03 | joint pain |
101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headac...
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101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headache with light sensitivity for days 1-5; muscle cramps; joint pain; nausea; extreme fatigue lasting several days.; This is a spontaneous report from a contactable Other Health Professional (HCP) (patient). A 62-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: EL0140), via unspecified route of administration on left arm on 12Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history included Rheumatoid Arthritis, Asthma, Hypertension, Multiple allergies, Peripheral Neuropathy, degenerative disc disease, known allergies: Sulfa drugs; Tetracycline; Nsaids; Aspirin; Ioxinol; multiple pollens & molds; capsicum, peppers, black tea, black cohosh, and more. Concomitant medications included valsartan (DIOVAN), adalimumab (HUMIRA), leflunomide, hydroxychloroquine phosphate (PLAQUENIL), montelukast sodium (SINGULAIR) and levocetirizine dihydrochloride (XYZAL). The patient previously received first dose of BNT162B2 at the age of 61 years old on 22Dec2020 (first dose, Lot number: EL1283, 03:00 PM, Left arm) for covid-19 immunisation. The patient experienced 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; muscle cramps, joint pain, nausea, and extreme fatigue lasting several days on 12Jan2021 at 04:00 PM. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.
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| 62 | 2021-02-03 | muscle pain, joint pain |
chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weaknes...
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chills day 1 and 2; tiredness; headache; muscle pain; joint pain; feeling unwell; dizziness; weakness; sleeplessness; sinus unable to drain, feels like sinus infection but no fever; This is a spontaneous report from a contactable health care professional (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283) in the hospital, via intramuscular route of adminsitration on 08Jan2021 at 15:00 at a single dose on the left arm for COVID-19 immunization. Medical history included Diabetes, High blood pressure, Osteoporosis, Hyperlipidemia, GERD, Diverticulosis and allergies to soaps, shampoos and lotions all from an unknown date and unknown if ongoing. Concomitant medication included metformin (manufacturer unknown), losartan (manufacturer unknown), ezetimibe (manufacturer unknown), esomeprazole (manufacturer unknown), dulaglutide (TRULICITY) , hctz (manufacturer unknown), denosumab (PROLIA), Alive multi vitamin (as reported), vitamin d3 (manufacturer unknown), ascorbic acid, colecalciferol, copper gluconate, cyanocobalamin, durapatite, folic acid, glucosamine hydrochloride, magnesium oxide, manganese sulfate, phytomenadione, sodium borate decahydrate, zinc amino acid chelate (BONE UP), alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME) and curcuma longa rhizome (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]). The patient had no other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination. It was reported that the patient had chills day 1 and 2, tiredness, headache, muscle pain, joint pain, feeling unwell, dizziness, weakness, sleeplessness and sinus unable to drain, feels like sinus infection but no fever all on 08Jan2021 at 19:00. The patient took Advil, Mucinex and Walphed as treatment for the events. The outcome of the events was not recovered. The patient has not been tested for COVID-19 post vaccination.
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| 62 | 2021-02-03 | muscle pain |
Patient with headache, muscle aches, nausea. then developed palpitations and dull constant nonexert...
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Patient with headache, muscle aches, nausea. then developed palpitations and dull constant nonexertional chest ache for several hours resolved with fluids and Tylenol/motrin.
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| 62 | 2021-02-04 | back pain |
lower left side back pain; received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12...
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lower left side back pain; received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12:53PM in the left arm/ she noticed a sore arm right afterward; rash; This is a spontaneous report from a contactable consumer reporting for herself. A 62-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: not reported), via an unspecified route of administration, on 15Jan2021 12:53PM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. It was not administered at a military facility. The patient did not receive other vaccines within 4 weeks prior to receiving the Pfizer vaccine. Medical history included allergies/allergy from childhood 4 years old, back problem from 2001, back surgery in 2015, vaginal dryness, high cholesterol, depression, acid reflux, surgery in 2015, physical therapy, and allergy to mold, dogs, roaches. She has multiple allergies from childhood including allergy to mold, dogs, and roaches. She also mentioned she has had back problems since her first surgery in 2015. All of these predate treatment with Pfizer COVID 19 vaccine and Lipitor. She got to where she couldn't stand up straight, but she went to physical therapy. She had surgery in 2015. She had a problem in 2018 and they gave her shots and that helped. Family history was none. Concomitant medications included estradiol (ESTRING) (for three years) for vaginal dryness, fish oil (taking for three to four years) for high cholesterol, paroxetine hydrochloride (PAXIL) (taking for 20 years) for depression, cyamopsis tetragonoloba gum (BENEFIBER FIBER SUPPLEMENT) (using for a year), vitamin d3 (VITAMIN D3) (using for five years; she used to be on calcium but it can cause heart problems so her doctor told to take Vitamin D), dexlansoprazole (DEXILANT) (taking for five years) for acid reflux, (ALLEGRA) (taking for 5 years ) for allergy, (QNASL) (using for 3 years), allergy shots (used forever) for allergy and stool softener (taking for 5 years) to "keep things moving"; all were from unspecified dates and ongoing. The patient previously took atorvastatin (LIPITOR) for high cholesterol from 2017 to 2017 and experienced back pain from 2017 to 2017 (recovered). She also previously took calcium. The patient experienced "received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12:53PM in the left arm/ she noticed a sore arm right afterward" on 15Jan2021, lower left side back pain on 20Jan2021, and rash on an unspecified date in Jan2021. The patient called to report a problem with her lower back after receiving the 1st dose of the vaccine. "I've had surgery and a couple of shots, the CAT scan kind. I have been fine for a while, just had a sore arm and yesterday I noticed a problem with my lower back and thought it may have been because I painted, but it is still bothering me. I remembered when I went on Lipitor I started having problems with my back about 3 weeks in, same deal. The doctor took me off and I went back on a month later and I started having problems again. Because I don't know if it was the vaccine, I am wondering if I should get the second dose." She clarified she received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12:53PM in the left arm. She noticed a sore arm right afterward which lasted at least 48 hours. Then on 20Jan2021, she noticed lower left side back pain. Mentions she thinks it is at the L4 or L5 and this is the same place she had a shot there in 2018 for back pain and previously had surgery on that location in 2015. With regard to Lipitor, she is unsure of the exact year, but states it was probably back in 2017. After taking Lipitor she noticed her back pain coming back. Her doctor took her off of Lipitor for a month and it got better. Then he put her back on Lipitor and she had the same back pain problem. She stated that she is unsure if she will take the second dose and asked with regard to her back pain should she take the second dose. Outcome of "received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12:53PM in the left arm/ she noticed a sore arm right afterward" was recovered on 18Jan2021, outcome of lower left side back pain was not recovered, while outcome of rash was unknown.
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| 62 | 2021-02-04 | weight decreased |
Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible...
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Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21
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| 62 | 2021-02-07 | joint pain | Headache, Fever chills times four days, mouth sores, swollen lymph nodes, joint pain, fatigue. |
| 62 | 2021-02-08 | muscle pain |
heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This i...
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heart rate of 160; severe nausea; arm soreness; muscle soreness in left arm; general fatigue; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283), via an unspecified route of administration on 21Jan2021 13:00 at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 62 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) administered on 30Dec2020 at 01:00PM and the patient said she did not have a reaction after the first vaccine. The patient received no concomitant medications. She stated that she had no other recent vaccinations or new medications. One thing that may be important is that she did do a 7 day detox that ended the Sunday before her second vaccine dose, so her body was pretty much having no impurities in it, and she has been eating clean since then, maybe having something foreign put into her body set it off after detox. The patient experienced arm soreness and general fatigue on 21Jan2021, and on 22Jan2021 at 01:00 she experienced severe nausea and heart rate of 160 (which was reported serious as medically significant). Patient reported that after her second dose of the COVID-19 vaccine she had a significant side effect that didn't happen until 10-12 hours after getting the vaccine. She did not have a reaction after the first vaccine. After the second injection her arm was sore, and she had general fatigue. She had the second dose injected Thursday at around 01:00PM, then at one in the morning her heart rate was 160, and she had severe nausea. She was that way until 08:00AM. Her heart rate was 120 probably by 09:00AM, then came down to 100, she has never had anything like that before. Her arm soreness was a deep muscle soreness to her left arm. The fatigue was a couple hours later after she got the second dose of the vaccine. The nausea started at 01:00AM, and lasted until six to eight, she did no treatment, and it improved and is still gone now. For her heart rate of 160, she had no treatment, though she probably should have gone to the hospital, but it came down. She usually runs a heart rate of 60-70, it went back to normal Friday, probably in the afternoon on the 22nd, about 12 hours after that started. The patient stated that she feels this is medically significant for her heart rate to be that high. She had contacted her primary care physician (PCP), but they didn't call her back for 4-5 hours, by then she was fine. She doesn't think that this was treated well by her PCP, and that they should have done an electrocardiogram (EKG) and follow up labs, she is changing her PCP as a result of this. She is concerned about the people who will be getting their second dose, she has been helping with these, they have patients that are over 100, they wouldn't survive that rapid heartbeat. The outcome of arm soreness/muscle soreness and fatigue was unknown.; Sender's Comments: The reported event of heart rate increased was likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 62 | 2021-02-09 | joint pain, armpit pain |
Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date...
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Moderate to severe fatigue; moderate nausea; slight joint pain; Vomiting; Dose 1 administration date 21Dec2020, Dose 2 administration date 07Jan2021; severe underarm pain; moderate chills; shaking; severe migraine-like headache; This is a spontaneous report from a contactable other health professional reporting for herself. A 62-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EK4176), via an unspecified route of administration on 07Jan2021 10:30 AM at single dose in Right arm for COVID-19 immunisation. Medical history included IV dye allergy and Allergy when on antibiotics from an unknown date. Concomitant medication included acetylsalicylic acid (ALKA SELTZER) received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140) on 21Dec2020 10:30 AM in Right arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced vomiting 12 hours after second injection on 07Jan2021 at 10:30 PM, then severe underarm pain and moderate chills and shaking 14 hours after, then severe migraine-like headache and slight chills 22-26 hours after. Moderate to severe fatigue, moderate nausea, slight joint pain for another 2 days, on 10Jan2021. Third day after injection was slight nausea and moderate fatigue. Fourth to sixth day after injection was slight fatigue. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the adverse event. The outcome of events was recovered. The case was reported as non-serious.
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| 62 | 2021-02-11 | armpit pain |
Severe body aches, headache, pain under arms, pain at injection site and could not lift arm for 26 h...
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Severe body aches, headache, pain under arms, pain at injection site and could not lift arm for 26 hours
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| 62 | 2021-02-12 | armpit pain, muscle pain |
The day of the shot, I was fine. But I went to bed at about 10:00 that night and slept very little...
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The day of the shot, I was fine. But I went to bed at about 10:00 that night and slept very little. I was chilling so badly that I couldn't get to sleep! When I got out of bed in the morning, I could barely move due to severe muscle pain. I did very little all day, suffering from what felt like the flu: chills, loss of appetite, and "brain fog" such that I couldn't read or think clearly. My head felt warm, but I never took my temperature. The next morning, I noticed hives on my chest between my breasts and around the armpit of my left arm. The following morning, now about 45 hours after my second injection, I still had pink hives, and my left armpit was swollen so that it wasn't concave, as it always is, but convex. Touching my armpit hurt, and I think some gland in it was swollen. Similarly, a gland on the left side of my neck was swollen and painful to the touch. Today, now the fourth day since the injection, the hives have subsided, and my glands are almost back to normal. Overall, I am very glad to have had the opportunity to get the vaccine, but I haven't felt that sick in years.
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| 62 | 2021-02-14 | joint pain, muscle pain | Extreme fatigue, chills, headache, joint and muscle aches, nausea. |
| 62 | 2021-02-14 | back pain |
01/07/2021 Started having low back pain on right low back took Advil on the 01/08/2021 horrible pain...
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01/07/2021 Started having low back pain on right low back took Advil on the 01/08/2021 horrible pain the radiates around pelvic area and across the whole lower back, called off work and went it to Physician in the afternoon. Examined for Muscular Cellular was prescribe Flexeril 10mg once a day at bedtime, Naproxen 500mg twice a day. Took them about three days was able to go back to work.
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| 62 | 2021-02-16 | joint pain | joint pain |
| 62 | 2021-02-18 | muscle pain, joint pain |
Fever, headache, dizziness, muscle and join pain/aches - at time severe, hives, nauseous/stomach ach...
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Fever, headache, dizziness, muscle and join pain/aches - at time severe, hives, nauseous/stomach ache similar to indigestion, loss of appetite, injection site pain, fatigue
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| 62 | 2021-02-18 | muscle pain |
I woke up with runny nose and constant sneezing, muscle aches and pains. Fever 103 and chills and un...
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I woke up with runny nose and constant sneezing, muscle aches and pains. Fever 103 and chills and uncontrollable vomiting. Suspects cerebral edema because of head ache and vomiting. Took 8 mg of dexmetholzone and Zofran. Neither were helpful. I took a shot of emetrex in case of a migraine. Vomiting has stopped but fatigue and weakness persists.
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| 62 | 2021-02-19 | armpit pain, muscle pain |
Felt severe muscle pain and aches the next day starting about 2:00 pm . Went to bed about 6:30 that ...
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Felt severe muscle pain and aches the next day starting about 2:00 pm . Went to bed about 6:30 that night. Woke up in the middle of night and I could tell I had a "huge lump" in my Lt armpit. The lump is very sore. No redness or hot to touch. I am going to watch it over the next few days. If it gets bigger or red, I will seek medical advise. I am guessing it is a inflammatory reaction to the vaccine and my lymph nodes are inflamed there. No other lymph nodes are swollen any where else.
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| 62 | 2021-02-21 | muscle pain, neck pain, joint pain |
The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teet...
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The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.
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| 62 | 2021-02-24 | back pain |
Pain in left back/rib cage radiating to front of chest. No blistering rash yet. Patient also report...
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Pain in left back/rib cage radiating to front of chest. No blistering rash yet. Patient also reports itching and burning sensations in affected area. Patient went to urgent care (2/25/21) and was diagnosed with shingles. Patient was prescribed valtrex.
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| 62 | 2021-02-24 | weight decreased |
persistant nausea/nausea become much worse on day 4; fatigue; slight appetite loss; unable to eat no...
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persistant nausea/nausea become much worse on day 4; fatigue; slight appetite loss; unable to eat normally; lost much weight; This is a spontaneous report from a contactable consumer reported for herself. A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EM980) , on 04Feb2021 at 16:00 (at 62 years) at single dose in left arm for covid-19 immunisation . Medical history included glucose intolerance. Patient was not pregnant.Concomitant medication included atenolol and calcium/ergocalciferol (CALCIUM/VITAMIN D). The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) and experienced allergy. On 08Feb2021 at 08:00 (as reported) the patient experienced persistent nausea, fatigue, slight appetite loss, unable to eat normally and lost much weight, all non serious. Events were described as follows: patient had persistent nausea. The first few days she had the expected side effects of fatigue and slight appetite loss. The fatigue resolved on the second day, but the nausea become much worse on day 4. She had been unable to eat normally since then and had lost much weight that she cannot afford to lose. She kept hoping that it will go away, but it was 8 days after her shot and she still had nausea (as reported). Anti nausea medicine was administered, no treatment given for the other events. Patient recovered from fatigue in Feb2021; outcome of the other events was not recovered.
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| 62 | 2021-02-25 | muscle pain |
body ache, head ache, nausea, diarrhea, weakness, muscle pain, moving body pain, food intolerance, t...
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body ache, head ache, nausea, diarrhea, weakness, muscle pain, moving body pain, food intolerance, thirst, shaking, feeling of crawling out of body. Lasted 3 1/2 days. Last 2 days shaking and crawling out of body feeling was not present. Diarrhea only day 1. Nausea lasted 1 1/2 days. Day 4 no adverse effects remained. Not certain if the above was related to vaccine but timing seemed to match.
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| 62 | 2021-02-26 | muscle pain |
high heart rate, muscle aches and pains, left arm still hurts, still swollen in areas. My arm flet ...
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high heart rate, muscle aches and pains, left arm still hurts, still swollen in areas. My arm flet like it had a fever at injection sight. I was pale in face.
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| 62 | 2021-02-28 | muscle pain, bone pain |
4 inch area at injection site hard, red, hot. Extreme fatigue. Slight fever. Muscle and bone ache. R...
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4 inch area at injection site hard, red, hot. Extreme fatigue. Slight fever. Muscle and bone ache. Rash and itch on abdomen. Itch at injection site. Symptoms slowly decreasing over time, but not yet gone.
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| 62 | 2021-03-03 | back pain | Chills, slight fever, back ache - lower and upper back, headache |
| 62 | 2021-03-03 | muscular weakness | Extreme pain , weakness in right arm . Can?t lift arm . For two weeks already |
| 62 | 2021-03-03 | muscle pain |
WITHIN MINUTES OF THE SHOT, FELT LIGHTHEADED & DIZZY. AFTER 40 MINUTES, EXPERIENCED LIP TINGLING, IT...
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WITHIN MINUTES OF THE SHOT, FELT LIGHTHEADED & DIZZY. AFTER 40 MINUTES, EXPERIENCED LIP TINGLING, ITCHY/SCRATCHY THROAT, ITCHY SKIN, A COUPLE OF STRAY HIVES. ALL OF THESE SYMPTOMS WERE MILD, AND PASSED AFTER A COUPLE OF HOURS. THE NEXT DAY HAD A VERY BAD HEADACHE. ABOUT 18 HOURS AFTER THE SHOT BECAME ILL WITH FLU-LIKE SYMPTOMS. HEADACHE, CHILLS, MUSCLE ACHES, LOW GRADE FEVER, CHEST TIGHTNESS/PRESSURE, HEAD & CHEST CONGESTION. ALL RESOLVED JUST ABOUT 48 HOURS AFTER THE SHOT.
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| 62 | 2021-03-04 | armpit pain, groin pain |
I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day...
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I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day 10 after the vaccine and my mast cell reactivity symptoms have increased by the day--internal and external swelling, flushing, pruritis, wheezing, tightness in chest, as well as pain and pressure in arm pits, groin, and ears. By late afternoon I am severely fatigued, weak, and foggy-headed. These symptoms are consistent with those I experienced during the twenty years when my mast cell disease was unstable. Through identification of my triggers and avoidance of the same, I have been symptom and medication free for the past three years--until taking the Covid-19 vaccine. It appears that the vaccine has reactivated an excessive degranulation response in my mast cells and that response is getting worse as my body responds to the vaccine. I realize that the percentage of persons who suffer from a condition like mine is small, but I would have appreciated having the information that I am submitting to you when I was weighing the pros and cons of vaccination. I know from the twenty years of navigating this disease that there is nothing that can be done at this point other than taking various H1 and H2 blockers. This vaccine appears to be undoing the hard-won level of stability achieved through years of careful lifestyle management.
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| 62 | 2021-03-04 | armpit pain | Rash, itching, swollen lymph nodes under right arm |
| 62 | 2021-03-04 | muscle pain, joint pain |
Developed the following approx 15-17 hours after injection: Low grade fever 100.2 Muscle and joint a...
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Developed the following approx 15-17 hours after injection: Low grade fever 100.2 Muscle and joint ache Fatigue Headache Took two Tylenol which brought fever down and slept. Took two more Tylenol at bedtime and felt normal the following morning.
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| 62 | 2021-03-05 | joint pain, neck pain |
On day 10 I woke with achey shoulders, neck and hands. Later in day had mild chills and overall ache...
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On day 10 I woke with achey shoulders, neck and hands. Later in day had mild chills and overall aches and by evening had 101.5 temp and flushing of face along with mild headache. Tylenol taken along with warm shower and early bed. Woke in am with mild headache, loss of appetite. Felt better by 11am and after a cup of tea. By afternoon I felt 100% back to normal. No rashes or even a sore arm post vaccination in the days prior to this event on day 10.
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| 62 | 2021-03-07 | joint pain, muscle pain |
8:00 am 3/3/2021 had severe muscle and joint aches. Area of injection was red all around in large ar...
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8:00 am 3/3/2021 had severe muscle and joint aches. Area of injection was red all around in large area and warm to rich. Was lethargic.
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| 62 | 2021-03-07 | joint pain, muscle pain |
Saturday evening injection sight started hurting. Woke up Sunday morning to nausea, dizziness, chil...
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Saturday evening injection sight started hurting. Woke up Sunday morning to nausea, dizziness, chills, muscle and joint pain, headache, tiredness
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| 62 | 2021-03-08 | joint pain |
Significant joint pain; fatigue; left arm pain. - Joint pain lasted 3 weeks from 12/27/2021 - 1/19/...
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Significant joint pain; fatigue; left arm pain. - Joint pain lasted 3 weeks from 12/27/2021 - 1/19/2021; Called Dr. - telemed visit - 1/18/2021. I had not recovered from the adverse symptoms of first dose before getting second dose. I had the second dose on January 19, 2021 - had joint pain but I did so much easier than this first dose.
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| 62 | 2021-03-08 | joint pain | excessive fatigue, headaches, joint pain, loss of appetite, feeling unwell |
| 62 | 2021-03-08 | muscular weakness |
Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my ...
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Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my hand started to pain a lot; I couldn't even touch my own self it was so sensitive; may be I'm inflamed; nausea; severe pain/ my waist my back is so painful; My body feels so weak; my fingers and hand; It triggered the shingles pain in my back; It triggered the shingles pain in my back; had no appetite, I didn't eat; She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiration date: May2021), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included shingles which she contracted in 2019, about one and a half years ago, it was a shingles on her back and lower back which she stated were the worst place for shingles has attacked, it left her with severe pain in both legs; diabetes; and high blood pressure. Concomitant medications included losartan, atenolol (a beta-blocker), and metformin for diabetes. The patient took the vaccine on 22Jan2021 and after about 2-4 days (Jan2021), she had a little chill and got very tired. She had to take care of herself. She was very tired not realizing it was the shot she took. She also felt like she has no energy. The patient was working from home but a lot of times, she was lying on the couch. Over the weekend (Jan2021), she had a slight pain on left arm. About a week or 8-10 days later (2021), she got very tired and couldn't even sit up. Her body was not itself. She started to feel like a bus rolling over her, like somebody took a baseball bat and beat her really bad. The patient uses her arm a lot and her hand started to feel a lot of pain. She couldn't even touch herself; it was so sensitive. She took paracetamol (TYLENOL) but it didn't work. She had celecoxib (CELEBREX) an anti-inflammatory, she thought she was maybe inflamed, but it didn't work. She had some diclofenac cream, she rubbed it, but it didn't work. The patient had shingles about a year and a half ago which was very bad. She just felt weak and didn't feel like herself anymore. She had a little bit of nausea and her whole body was really terrible. When she had the shingles, it left her with severe pain in both legs. She saw a neurologist and told her that she would have to take pregabalin (LYRICA) and it would go away. So, when she had severe pain last week, she took pregabalin but it didn't help. The patient took half of acetaminophen, oxycodone (PERCOCET) as she was not the person who takes pills, but it didn't work. Her body was so severe on Friday, it was not going away, the pain was there 24 hours. The patient has been experiencing this for 8-10 days now. She took one PERCOCET on Friday and had a slight relief and didn't took anything again. She kept rubbing the diclofenac cream, but it was not much of a relief. This morning, she has to work, she was sitting so she took PERCOCET. She is getting her second shot on Friday, 12Feb2021. She asked how she will feel after the second dose if she felt that way after the first dose, if the first shot was adequate, and if she should take the second dose. She stated that she didn't want to take the second dose. Her body felt so weak including her fingers and hand. It triggered the shingles pain in her back and felt like she was beaten up by someone. She has to lie down for the pain in her back. She also mentioned that she couldn't sit for so long as her waist and back were so painful. She was lying on a heating pad and ice and nothing was working. She even has a hard time getting up. She thought what happened was it triggered the shingles pain in her back and also left her with a problem under her feet. The shingles left her with some kind of damage when she took the shot. It was really bad. Her son was a physician and was concerned because last week, it got so bad, she didn't come out, she was in bed and bedridden from Friday to Sunday. She had no appetite, she didn't eat. The only thing that the patient had was diabetes and high blood pressure, but it was under control. She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit, but before my pressure was like 120 something, over 68 or 72 it was always around the 60s and 70s. Since she was having this, it was a little high. The outcome of the events was unknown.
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| 62 | 2021-03-08 | muscle pain |
The first reaction - 15 minutes after the vaccine - I felt really dizzy and loopy. She told me, I th...
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The first reaction - 15 minutes after the vaccine - I felt really dizzy and loopy. She told me, I think you better sit back down. I felt better after sitting there for 30 minutes after. I didn't get dizzy again. I finished my workday. Next morning, I woke up with a fever 100.8 (about). I woke up with sore muscles - I tend to get sore muscles easily but I felt more sore than normal and I had a headache. Fever stopped after 24 hours. Note: I also get dizzy really easily - and so it isn't difficult for something to make me dizzy. I also felt really tired. And over the weekend, I felt nauseated (not initially but over the weekend.) And that lasted until about midday Monday (over the weekend) to be getting better . I took Tylenol and I rested. That helped with the symptoms.
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| 62 | 2021-03-08 | neck pain |
Significant neck pain and muscle spasm 48 hours after vaccination, aseptic meningitis 3 weeks after ...
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Significant neck pain and muscle spasm 48 hours after vaccination, aseptic meningitis 3 weeks after vaccination requiring hospitalization.
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| 62 | 2021-03-10 | bone pain | extreme bone pain, diarrhea, insomnia |
| 62 | 2021-03-10 | muscle tightness |
Lips began tingling (similar to when administered novocaine at the dentist) and tightness along jawl...
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Lips began tingling (similar to when administered novocaine at the dentist) and tightness along jawline to left ear after I left the site, approximately 40 minutes after injection. After about 1 1/2 hour the sensation lessened.
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| 62 | 2021-03-10 | muscular weakness |
I lost muscle control while playing tennis for about 5 minutes. After that I felt very tired, queez...
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I lost muscle control while playing tennis for about 5 minutes. After that I felt very tired, queezy, dizzy for about two days.
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| 62 | 2021-03-11 | joint pain |
Shortness of breath; joint pain in hands; Headache; coughing with extreme pain and described a feeli...
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Shortness of breath; joint pain in hands; Headache; coughing with extreme pain and described a feeling of bugs crawling in her lungs, bugs front and back/ painful cough; itching; This is a spontaneous report from a contactable nurse. This case was also received from Pfizer sponsored program. A 62-year-old female patient received the 2nd dose (at the age of 62-years-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration in Feb2021 at SINGLE DOSE for COVID-19 immunization. Medical history included lung and back problems (back pain). It was reported that the patient normally took an inhaler (not steroid inhaler because she didn't want to interfere with immune response), and other things. The patient previously took prednisone which started at 40mg for 2 days, 30 for 2 days, 20 for 2 days then goes down to zero for back pain (stopped taking 4 days before the second dose of the vaccine). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot# not provided) on 29Jan2021 (at the age of 62-years-old) for COVID-19 immunization. The patient's 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE was administered a week ago (Feb2021) Friday. It was reported that she got very ill initially which she said joint pain in hands and headache noted in Feb2021 (Saturday) which wasn't so bad. On Saturday afternoon, she reported shortness of breath, coughing with extreme pain (painful cough) and described a feeling of bugs crawling in her lungs, bugs front and back, and itching, and no one else reported it. The patient kept sleeping and waking up, thinking she was alright, but the coughing and lasted until Sunday evening, it was a very painful cough, and a creeping sensation in lungs front and back. She missed work on Monday. The events (joint pain in hands, headache, shortness of breath, coughing with extreme pain (painful cough) and itching) were medically significant as she was unable to go to work. It was also mentioned that since the patient stopped taking the Prednisone 4 days before the second dose of the vaccine. The patient had an exacerbation of pain (it came back). The patient was also wondering when can she start the inhaler and steroid for the back as she has lung and back problems. Outcome of the events were unknown. Information on lot number/batch number has been requested.; Sender's Comments: Based on data provided, the reported events are assessed as possibly related to BNT162B2. This case will be reviewed upon receipt of further information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 62 | 2021-03-11 | joint swelling, grip strength decreased |
Exactly 12 hrs after second injection I had 103 temperature, severe shakes and chills. Both knees an...
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Exactly 12 hrs after second injection I had 103 temperature, severe shakes and chills. Both knees and arms at the elbows swelled and the elbow and Lymph nodes on my right inner elbow are still swollen. I am just now able to grip anything with my Left hand. I had both vaccines in my right arm. I am predominantly left handed. This has affected my work asin which I am still working full time.
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| 62 | 2021-03-11 | musculoskeletal stiffness |
Arm Pain (injection side) ...Within 5 minutes of injection. Mild neck and torso stiffness...Began 2 ...
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Arm Pain (injection side) ...Within 5 minutes of injection. Mild neck and torso stiffness...Began 2 hours and 40 minutes after injection. Wheezing...Began about 4 and a half hours after injection. Shortness of breath occurred overnight. 8 hours after injection. ...checked oxygen level at 93 Moderate widespread aching...8 hours after injection. 15 hours after injection...oxygen level at 88 15 hours after injection...Temperature of 99
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| 62 | 2021-03-12 | joint pain |
Initial soreness to bilateral arms at elbows. Progressionn beginning Wednesday, March 10 to moderat...
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Initial soreness to bilateral arms at elbows. Progressionn beginning Wednesday, March 10 to moderate to severe pain to same areas and currently.
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| 62 | 2021-03-13 | joint pain |
Headache first 30 min, malaise 6-7 hrs after , joints shoulders and hands/fingers x48 hrs moderate /...
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Headache first 30 min, malaise 6-7 hrs after , joints shoulders and hands/fingers x48 hrs moderate /severe then lessening, Swollen Armpit lymph node 3 in x 4 in for 48 hrs then getting smaller . Severe to moderate pain . Congested all days , needed Inhaler first 24 hrs , benedryl and decongestant , naproxen and Tylenol needed all days
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| 62 | 2021-03-13 | muscle pain, armpit pain, joint pain |
After receiving my first Pfizer vaccine on 2.24.21 at 4:45 p.m., I felt well. I woke the next morni...
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After receiving my first Pfizer vaccine on 2.24.21 at 4:45 p.m., I felt well. I woke the next morning 2/25/21, and felt fatigue, arm was tender but not sore. Earlier that morning, I had an aura, but no migraine materialized. Around 10 a.m., I began to have chills, more fatigued, and sore muscles. Left work at 3 p.m. Arrived home, went to bed with temperature of 101.2. Took Tylenol. Friday, Fever was gone, felt fatigued, arm still tender, and had a headache. Took Tylenol. Did not go to work on 2/26/21. Saturday, 2/27/21, woke at 4 a.m., right arm where vaccinated was very sore, armpit very sore, and right breast very sore. Placed cool compresses on my breast, arm pit and arm where vaccine was given. Took Tylenol. Still fatigues, achy, with sore shoulder muscles. Sunday, 2/28/21, Vaccine arm still sore, with some soreness still in right breast area. Took Tylenol. 3/1/21, called Dr. Still a bit achy and arm still tender
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| 62 | 2021-03-13 | neck pain |
The night of the injection, I had severe pain in my neck, back of my head and right arm. The pain w...
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The night of the injection, I had severe pain in my neck, back of my head and right arm. The pain was so severe that I could not move my head or arm all night. I took Advil but could not sleep from the pain. When I did manage to sleep, I would have horrible dreams. By morning, I was feeling better but still sore from my neck and arm. I felt very tired and rested the entire next day. Pain has not returned. It was very scary.
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| 62 | 2021-03-14 | muscle pain | Fever, 101.5, rash on legs arms, muscle aches |
| 62 | 2021-03-14 | neck pain |
Client received first COVID vaccine on 03/05/2021 about 1100 am, reaction noticed on 03/07/21 early...
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Client received first COVID vaccine on 03/05/2021 about 1100 am, reaction noticed on 03/07/21 early in the day, exact time not known. Client report vaccine given in left arm (deltoid), reaction on top of left shoulder. Reaction is a lump, the size of "2 big marshmallows" on top of her shoulder, with left sided neck pain and fatigue. No redness, pain or restriction with movement at reaction site. Client has applied ice and taken Tylenol for reaction. Client has an appointment with PCP tomorrow, 03/16/21.
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| 62 | 2021-03-15 | muscle pain |
Whole body is sore like as if I just ran a mile and every muscle hurts. shoulder/injection site hurt...
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Whole body is sore like as if I just ran a mile and every muscle hurts. shoulder/injection site hurts. Legs especially hurt.
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| 62 | 2021-03-16 | joint pain | Tinnitus, hearing loss, joint pain, sore at injection |
| 62 | 2021-03-16 | joint pain |
Myriad of symptoms first dose 12/16/21 runny nose, fatigue, sore throat, chills, and diarrhea -ne...
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Myriad of symptoms first dose 12/16/21 runny nose, fatigue, sore throat, chills, and diarrhea -negative Covid test day 8 Only one symptom second dose 1/5/21 only severe body aches Beginning March 3, 2021 onset of severe joint arthralgia in wrists, hands, elbows, shoulders, knees, and feet. This is along with fatigue and inability to walk or move without pain. This has exacerbated my carpal tunnel to becoming unbearable as well. This is totally NEW and NEVER had this before. If I had to describe the pain it is like inflammation similar to description of Rheumatoid Arthritis. NSAIDS are barely helpful and contraindicated as I have GERD with Barrett's esophagus. I have heard this reaction has been reported with post vaccination patients.
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| 62 | 2021-03-17 | back pain | 3 hours of chills and intense back pain. |
| 62 | 2021-03-17 | muscle pain, armpit pain, rheumatoid arthritis, joint pain |
tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertip...
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tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertips and toes were very painful-burning sensation; fingertips and toes were very painful-burning sensation; Underarm pain-throbbing; skin hurt when applying lotion; Low grade fever 99.9; This is a spontaneous report from a contactable other healthcare professional (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262), intramuscularly at right arm on 29Jan2021 11:00 at single dose for COVID-19 immunization at workplace clinic. The patient's medical history included autoimmune disorder, kidney disease, angina, and high blood pressure. There were other medications that the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies: Simvastatin, Tramadol, Codeine. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), at the age of 62-year-old, intramuscularly at right arm on 09Jan2021 13:15 at single dose for COVID-19 immunization at workplace clinic. It was reported that on the 2nd day after the vaccine (30Jan2021 13:00) patient started having body aches, muscle pain, joint pain, nerve pain. Her fingertips and toes were very painful-burning sensation. Also reported underarm pain-throbbing. Her skin hurt when applying lotion. Had low grade fever 99.9. Treatment was received for the above mentioned events: Tylenol 500mg, 2 Caps Q6h. Patient was recovering from the above mentioned events. She do have an autoimmune disorder: her Rheumatologist is checking for Psoriatic arthritis. She had tested positive for Rheumatoid Arthritis (unknown outcome). No treatment for this condition at this time. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 or not prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 62 | 2021-03-18 | joint pain, muscle pain |
Swelling of the arm at the injection site, including soreness, and headache, fatigue, muscle ache, j...
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Swelling of the arm at the injection site, including soreness, and headache, fatigue, muscle ache, joint pain, slight fever - felt like I had the flu. Started overnight after the shot and lasted the entire next day. Treated with rest, hydration and Tylenol. Symptoms were gone by the following morning.
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| 62 | 2021-03-18 | joint pain | FEVER,NAUSEA,BODY ACHES AND JOINT PAIN |
| 62 | 2021-03-18 | joint pain |
About 6 hours after I got it, I felt tired. The next day, my arm was sore and my eyelids were swolle...
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About 6 hours after I got it, I felt tired. The next day, my arm was sore and my eyelids were swollen every day for about 5 days. I had aches and pain all over, itchiness, headache, joint pain over the next week. Around the 22nd, it stopped. It took almost 10 days for me to feel somewhat normal.
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| 62 | 2021-03-18 | back pain, muscular weakness, limb discomfort |
I had arm pain, aches, tired and vomited a few time. I felt weird all over. I had pain in my upper a...
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I had arm pain, aches, tired and vomited a few time. I felt weird all over. I had pain in my upper abdomen, legs and lower back. Chills and anxiety. On 2/8, I had a tele visit with my doctor. I took Tylenol as instructed to make sure that I didn't develop a fever. My doctor said that it could be from the vaccine. My left leg and foot were swollen on 2/13, so I called my doctor again and he sent me for a Doppler to check for a blood clot. I saw him on 2/15 in person. I have lower back pain and weakness in my legs at times, but it doesn't prevent me from doing anything. They feel heavy, especially if I walk for an extended period of time.
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| 62 | 2021-03-18 | muscle pain |
First DaY immediately after the shot: Strong itching around mouth; 40 minutes later: runny nose; st...
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First DaY immediately after the shot: Strong itching around mouth; 40 minutes later: runny nose; strong sense of back of throat and esophagus burning; sensation in lungs like...pulsing slight burn--If you can imagines a sparkler (yep, the kind from the 4th of July) being in your lungs that is only a little painful, more like a wiggle, than a painful sensation, that would describe it. 2nd day: really tired by 4PM, feeling feverish. Very tired . Tired enough that I accidentally left the house for a job interview wearing one white sock and one black sock. Which isn't normal for me. 3rd day: muscle aches. 4th days feels like a really mild virus. This is not me but another person from my former job said she had spontaneous canker sores from the Pfizer shot.
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| 62 | 2021-03-18 | muscle pain |
About 30 minutes after vaccine, started to have a hard time breathing, short of breath & "chest fe...
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About 30 minutes after vaccine, started to have a hard time breathing, short of breath & "chest felt heavy" while at work at desk. Called an ED response- taken to ED was monitored for 4 hours, then released to home. That evening experienced fatigue, headache, muscle/body aches, feverish, which continued on 1/19 ,1/20, 1/ 21. felt better on 1/22/21 afternoon.
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| 62 | 2021-03-19 | armpit pain |
My arm has remained sore since the shot 4 days ago. Specifically in the armpit but aches all the wa...
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My arm has remained sore since the shot 4 days ago. Specifically in the armpit but aches all the way down to my hand at time. My armpit is swollen and painful. The pain goes thru my underarm down to my hand. The pain makes it difficult to sleep. Tylenol doesn't take the pain away. At first I thought the pain was a side effect to the initial vaccine, but it got worse as time went on. Finally I researched it on line and saw that lymph nodes have been reported as swelling due to the vaccine.
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| 62 | 2021-03-19 | back pain | tingling in legs, nausea, headache, pressure in chest, back pain |
| 62 | 2021-03-20 | muscle pain | Malaise, fatigue, muscle aches, chills, sore skin, headache |
| 62 | 2021-03-21 | back pain, joint pain |
a little bit of hip and back pain; a little bit of hip and back pain; Such pain she couldn't stand u...
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a little bit of hip and back pain; a little bit of hip and back pain; Such pain she couldn't stand up or walk; Such pain she couldn't stand up or walk; Such pain she couldn't stand up or walk/Noticed increase in her pain; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203, expiration date: Jun2021), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunization and for autoimmune deficient. Medical history included sjogren's syndrome, rheumatoid arthritis from 2016 (reported as about 5 years ago), hip replacement, autoimmune deficient from 2007, and hip dislocates three times a year. Concomitant medication included tofacitinib ongoing citrate (XELJANZ XR, lot number: DR2042, expiration date: 31Jan2023), hydroxychloroquine, pregabalin (LYRICA), all three for unspecified indication. On 04Mar2021, the patient noticed increase in her pain. Such pain that she couldn't stand up or walk. The patient also had a little bit of hip and back pain on an unspecified date. The patient clarified that she has oxycodone as pain medication (med). The patient stated that she has too many medications that she has to take. Stated that her brain was dying. The patient also stated that she was doing fine and hasn't had pain like this. The patient did not know if it was an adverse reaction or what. The reporter seriousness for such pain she couldn't stand up or walk was assessed as disabling. The outcome of the events was unknown.; Sender's Comments: The causal association cannot be excluded between the reported events and vaccine use based on strong temporal association. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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| 62 | 2021-03-21 | muscle pain, armpit pain |
Sever body aches including to touch skin throughout body. Sever pain shooting through body and musc...
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Sever body aches including to touch skin throughout body. Sever pain shooting through body and muscle. Severe headache and lethargy. Swollen painful lymph node under left arm pit that continues...
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| 62 | 2021-03-22 | joint pain, muscle pain |
Woke up with bad headache in back of head. Throat was hurting & swollen. Chills, achy muscles all o...
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Woke up with bad headache in back of head. Throat was hurting & swollen. Chills, achy muscles all over. Knee joint hurting bad. Not hungry. Slept a lot after taking Tylenol. Next day by 12:00 pm, I felt better.
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| 62 | 2021-03-22 | joint pain | Soreness in clavicle area with swollen node size of eraser head on a pencil |
| 62 | 2021-03-22 | back pain |
Intense enough Chest pain; jaw pain; back pain; nausea; This is a spontaneous report from a contacta...
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Intense enough Chest pain; jaw pain; back pain; nausea; This is a spontaneous report from a contactable consumer. A 62-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm, on 18Feb2021 at 14:00 (Batch/Lot Number: EL9267) as SINGLE DOSE for covid-19 immunisation Medical history included hypertension and allergy to penicillin. Concomitant medication and pravastatin (PRAVASTATIN. On 19Feb2021 at 100am, the patient experienced chest pain and jaw pain where she seriously considered going to the ER. Also, the other common side effects of back pain and nausea. The outcome of the events was recovering. The patient was not hospitalized nor was treatment received.
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| 62 | 2021-03-22 | musculoskeletal stiffness |
1 week after 2nd dose, on 1/24/21, woke up with stiff neck (left rear cervical area) which proceeded...
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1 week after 2nd dose, on 1/24/21, woke up with stiff neck (left rear cervical area) which proceeded with nerve pain down left shoulder and arm. After 2 weeks with no relief OTC remedies, saw PCP on 2/8/21, who ordered PT. Saw chiropracter for neck pain on 2/8/21. Weekly PT appts x 5 weeks, no relief. Saw PCP again on 3/5/21 for extreme nerve pain in arm. Prescribed Tramadol for pain, put on 11-day course of Prednisone. Some pain relief, but not resolved. MRI ordered and completed on 3/19/21 with no findings except arthritis. Now being referred to Spine Clinic for further diagnosis.
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| 62 | 2021-03-22 | muscle pain |
extreme fatigue and whole body muscle ache. This person previously tested positive on 12/31/2020. S...
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extreme fatigue and whole body muscle ache. This person previously tested positive on 12/31/2020. She recovered and was having no symptoms. She received the vaccine upon the recommendation of her physician as she was recently diagnosed with cancer. With in 24 hours she reports that she was completely incapacitated with extreme fatigue and muscle pain "from her toes to her head". Injection occurred 3/6/21. Symptom onset 3/7/21. Date of contact by a case investigator was 3/22/21. Symptoms were still present and acute on 3/22/21.
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| 62 | 2021-03-23 | joint pain | Left shoulder pain Excessive tiredness not usually experienced (slept 11 hours on 2nd night) |
| 62 | 2021-03-23 | muscle pain | Chills, nausea, passed out, muscle aches |
| 62 | 2021-03-23 | muscle pain |
Occasional mild headache, occasional mild chills, a bit of gas, mild muscle aches, occasional hot fl...
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Occasional mild headache, occasional mild chills, a bit of gas, mild muscle aches, occasional hot flashes (more intense than usual) and occasional fatigue (usually starting around mid-afternoon) and lasting for three days, starting about 24 hours after second dose. No fever.
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| 62 | 2021-03-24 | joint pain |
ON 3/12/2021 I received vaccine at 12:15 pm. After it was administered I waited 15 minutes to see i...
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ON 3/12/2021 I received vaccine at 12:15 pm. After it was administered I waited 15 minutes to see if I got an reaction to it. I was fine until about 3:00pm in the afternoon that I started to feel fatigue, body aches, also had chest pains on left side and in shoulder. pain stayed rest of the night. subsided on Saturday and returned on Sunday. Went to Hospital Sunday Night qround 7:00pm to get heart check out.
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| 62 | 2021-03-25 | joint pain, musculoskeletal stiffness, rheumatoid arthritis |
Rheumatoid arthritis; little stiffness in her arm; she was not feeling very"/just felt little off; l...
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Rheumatoid arthritis; little stiffness in her arm; she was not feeling very"/just felt little off; little pain in her left arm where the vaccination was given; pain in her elbow; seems like her left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (lot number: EN6202 and expiration date: 30Jun2021) as 0.3 mL, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Vaccine last Friday (05Mar2021) and on an unknown date, she had little stiffness in her arm and she was "not feeling very" (incomplete sentence), you know she was just felt little off but other than that, not too bad. The patient also had a little pain in her left arm where the vaccination was given and some stiffness on unknown date. Since then, she had pain in her elbow on left arm and today (10Mar2021), the pain was pretty persistent and seems like her left arm was swollen. The patient also stated "I guess I should say, I have rheumatoid arthritis" (pending clarification)". The patient received treatment for the events, stated "The only thing I took in this morning is Tylenol." Outcome of the events was unknown.
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| 62 | 2021-03-26 | joint pain, muscle pain | Acute fatigue, muscle and joint pains that lasted about 24 hours. Required only extended bedrest. |
| 62 | 2021-03-26 | joint pain | Fever, chills, aching joints |
| 62 | 2021-03-26 | muscle pain |
Constant headache Body on fire Fatigue Nausea Dizziness Pain and muscle ache Anxiety High blood pr...
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Constant headache Body on fire Fatigue Nausea Dizziness Pain and muscle ache Anxiety High blood pressure
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| 62 | 2021-03-26 | neck pain |
Pain in neck, especially, has increased over the past couple of days. Very tired, aching, lethargic,...
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Pain in neck, especially, has increased over the past couple of days. Very tired, aching, lethargic, don't want to be bothered. Loss of appetite started today. Feel pressure in chest, but no cough to speak of.
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| 62 | 2021-03-27 | joint pain |
1st dose I had soreness in left arm and a stomach nausea the next day. 2nd dose I had at 2:00 p.m. ...
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1st dose I had soreness in left arm and a stomach nausea the next day. 2nd dose I had at 2:00 p.m. on 3/26/21. Woke up the next morning at 4:00 a.m. with pain in my arm and basically feeling terrible. I had pain in the arm, soreness under arm, achy and severe joint pain all over, headache over my eyes, extreme fatigue, chills on and off, a few instances of sweating, Generally felt really sick. Appetite decreased. The next night woke up in the middle of the night sweating, then later in the night with chills. Aching and pain in joints was miserable. By noon on 3/28/21 was feeling a lot better, still tired and arm just sore. Stomach still a little off.
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| 62 | 2021-03-27 | joint pain |
pain at injection site. nausea, chills, headache, joint aches, general unwell feeling. This starte...
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pain at injection site. nausea, chills, headache, joint aches, general unwell feeling. This started during the afternoon after receiving injection in the morning-Friday. This continued all the next day-Saturday. All was resolved by the following morning-Sunday.
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| 62 | 2021-03-28 | muscle pain |
Head , neck sinus, Whole body flu like muscle pain lasting ten days. High fever on tenth day. Unbea...
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Head , neck sinus, Whole body flu like muscle pain lasting ten days. High fever on tenth day. Unbearable pain. Took covid test was negative. Daily nausea and farting all day.
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| 62 | 2021-03-29 | joint pain, neck pain |
Normal sore arm in the beginning. A week later, I heard/felt a pop in my shoulder. My shoulder has...
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Normal sore arm in the beginning. A week later, I heard/felt a pop in my shoulder. My shoulder has been sore ever sense. I have tried applying heat and cold, but hasn't helped. Also tried anti-inflammatory. Pain is starting to move to my neck.
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| 62 | 2021-03-29 | back pain, neck pain |
I felt fine until 1:30 in the morning. I woke up with a low fever, 99.5, very achy all over (especi...
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I felt fine until 1:30 in the morning. I woke up with a low fever, 99.5, very achy all over (especially the shot arm, my neck and lower back) then noticed a big lump under my left armpit. It is soft and squishy, not hard like a tumor. The fever and aches only lasted one day with Tylenol. The lump is still present.
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| 62 | 2021-03-29 | back pain |
I had fatigue for 10 days plus. I started with pain in my upper right back about 2.5 weeks after the...
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I had fatigue for 10 days plus. I started with pain in my upper right back about 2.5 weeks after the 2nd Pfizer injection. Thinking it was a pulled muscle, I used heat, ice, took Ibuprofen, it has gotten worse each day. I noticed a scabbed over rash on the area and called my Dr. he never returned my call, so I called telehealth and sent a picture as the pain became tingling and moved up my neck and to the base of my head. He diagnosed it as Shingles. Today I have chills & a headache. After reading reports of some adverse reaction from the Covid -19 vaccine, I thought I should report this.
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| 62 | 2021-03-29 | back pain |
Ear ache in both ears immediately following vaccine. Next day fever , chills, headache, nauseous, a...
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Ear ache in both ears immediately following vaccine. Next day fever , chills, headache, nauseous, aches & pains mostly in back, exhausted, sore throat, oxygen was 87-90 , and heart rate 90. These symptoms lasted all day into the evening. The next morning 3/21/21 I felt better except for my ears, and throat still hurt, and my mouth had developed soreness and felt inflamed and raw in spots. Have several spots that are still tender. Mouth ears and throat still not well. Went through whole bottle of Mary?s magic mouthwash. Still no relief.
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| 62 | 2021-03-30 | joint pain, spinal pain | Chills, body ache, pain in my joints and spine, nausea, fatigue. |
| 62 | 2021-03-30 | joint pain |
Left arm did not have any feeings when I woke up in middle of the night; Chills; Fever 101.0; Body a...
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Left arm did not have any feeings when I woke up in middle of the night; Chills; Fever 101.0; Body aches in both knees; Sore right arm; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6206), via an unspecified route of administration in the right arm on 10Mar2021 at 09:15 for COVID-19 immunization. The patient was not pregnant. Medical history included Hypertension. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EI9267) in right arm on 19Feb2021 for COVID-19 immunization. The patient received other medication in two weeks. On 11Mar2021 at 03:00 AM, the patient experienced chills, fever 101.0, left arm did not have feelings at night, body aches in both knees and sore right arm. The patient did not receive any treatments for the events. The clinical outcome of chills, fever 101.0, left arm did not have feelings at night, body aches in both knees and sore right arm was recovering. No follow-up attempts are possible. No further information is expected.
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| 62 | 2021-03-30 | back pain, muscle pain |
had a sharp twinge in the upper back muscles/all over the upper back muscles; had a sharp twinge in ...
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had a sharp twinge in the upper back muscles/all over the upper back muscles; had a sharp twinge in the upper back muscles/all over the upper back muscles; This is a spontaneous report received from a non-contactable consumer (patient). This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Mar2021 at single dose for COVID-19 immunization. Medical history included neuropathy. Concomitant medications were not provided. Received vaccine the day before and overnight on 09Mar2021, the patient had a sharp twinge in the upper back muscles, it was all over the upper back muscles and then went away. Patient thought that her neuropathy was affected by the vaccine. This report is non-serious. It was unknown if the patient diagnosed with COVID-19 prior vaccination, unknown if the patient had been tested for COVID-19 since the vaccination. No treatment for the events. Outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 62 | 2021-03-30 | back pain |
On 3/20/21 pt started having diarrhea. Then she started getting chills, body aches, headache, dizzi...
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On 3/20/21 pt started having diarrhea. Then she started getting chills, body aches, headache, dizziness and nauseated. Her back and legs are hurting. She has had these symptoms for over a week. She has been taking anti-diarrhea meds and Tylenol and Advil. Pt will contact her PCP.
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| 62 | 2021-03-30 | muscle pain |
Muscle ache; headache; chills; temp of 99.3; This is a spontaneous report from a contactable 62-year...
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Muscle ache; headache; chills; temp of 99.3; This is a spontaneous report from a contactable 62-year-old non- pregnant female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 08Feb2021 14:45, at single dose in right arm for covid-19 immunization. The patient medical history included migraines. The patient had no known allergies. Historical vaccine included bnt162b2 (product: Covid-19, brand=Pfizer, lot unknown-False, administration date-18Jan2021, administration time-02:45 PM, vaccine location-right arm, dose number=1). The patient took the vaccine at workplace clinic. Concomitant medications were not reported. On 08Feb2021 at 23:45, the patient experienced muscle ache, headache, chills, and temperature of 99.3. The patient did not take any treatment for the events. The outcome of the events was recovered on an unknown date. Information about lot/batch number has been requested.
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| 62 | 2021-03-30 | neck pain, joint pain |
Pain in my right shoulder going up the right side of my neck into my right jaw and right eye on my d...
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Pain in my right shoulder going up the right side of my neck into my right jaw and right eye on my drive home. Came home and ate lunch. Sat in my recliner, put feet up. Fell asleep and woke up itching all over. Had itching in my tongue and the back of my throat. Took antacids and Benadryl before I went to bed. Next day woke up feeling better.
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| 62 | 2021-03-30 | neck pain |
I had the normal flu like symptoms for 2-3 days; whole upper left quadrant of my body. This includes...
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I had the normal flu like symptoms for 2-3 days; whole upper left quadrant of my body. This includes the chest area around where my heart is. It is very painful; my neck arm and shoulder were killing me; my neck arm and shoulder were killing me; whole upper left quadrant of my body. This includes the chest area around where my heart is. It is very painful; This is a spontaneous report from a contactable consumer. A 62-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: was not reported), via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 18:45 (at the age of 62 years old) as SINGLE DOSE for covid-19 immunization. The facility in which the vacation was given was a Pharmacy or Drug Store. Medical history included hypertension, blood cholesterol increased and covid-19 (prior to vaccination). The patient has no known allergies. Concomitant medications included lisinopril (LISINOPRIL), atorvastatin (ATORVASTATIN). No other vaccines were given within 4 weeks. Prior to vaccination, the patient 'was' diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 04Mar2021 at 00:00, The patient experienced flu like symptoms for 2-3 days, Pain chest, Neck pain, Arm pain and Pain. No Treatment was given. The clinical course was as follows patient had the normal flu like symptoms for 2-3 days. Then noticed that her neck arm and shoulder were killing me. Now it is the whole upper left quadrant of her body. This includes the chest area around where my heart is. It is very painful and I do cry out with a pain sound if I move a certain way. No treatment was given for the events. The clinical outcome of the event was not recovered. Information on the lot/batch number has been requested.
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| 62 | 2021-03-31 | joint pain, muscle pain, grip strength decreased |
very sick/Horrible; very painful muscles; very painful joints/The pain in all of her joints and musc...
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very sick/Horrible; very painful muscles; very painful joints/The pain in all of her joints and muscles was a total nightmare; extreme weakness; very weak hand grip strength; Anorexia; unable to walk, stand up or sit down without max assist; unable to walk, stand up or sit down without max assist; Headache; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: BL9264) via an unspecified route of administration, administered in arm right on 10Feb2021 12:30 as single dose for covid-19 immunisation. The patient medical history was not reported. Patient has no COVID prior to vaccination. Patient is not pregnant. No Known allergies. There were no concomitant medications. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261) via an unspecified route of administration, administered in arm left on 21Jan2021 11:00 AM for covid-19 immunisation at the age of 62 years old. Since 12Feb2021, patient was very sick, very painful muscles, joints, extreme weakness, very weak hand grip strength. Anorexia, unable to walk, stand up or sit down without max assist. Headache. Horrible. The pain in all of her joints and muscles was a total nightmare. Here it was nearly a month after, she was still quite painful and suffering with joint and muscle pain and weakness. These events resulted in physician office visit and emergency room visit and received treatment for the events, which included pain medication. Patient had COVID tested which included nasal swab (undated) and PCR on 16Feb2021 post vaccination, both results were unknown. Outcome of the events was not recovered.
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| 62 | 2021-03-31 | joint pain | TEMP OF 103F CHILLS AND FEVER NAUSEA ACHING JOINTS SEVERE HEAD ACHES |
| 62 | 2021-03-31 | muscle fatigue, limb discomfort |
5 days after shot developed pulling in both legs/developed into muscle fatigue in legs and in Rt arm...
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5 days after shot developed pulling in both legs/developed into muscle fatigue in legs and in Rt arm. Restarted Celebrex 200 mgs which had discontinued for 7 days (Incl 1 day prior to shot)/added 2-4 Tylenol 500 mgs per day/ice/heat/exercises for shoulders/back/legs. Still experiencing symptoms 2 wks after started 3/18/21.
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| 62 | 2021-04-01 | joint pain, armpit pain |
I had multiple severe side effects the next day and through the night the next day consisting of tir...
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I had multiple severe side effects the next day and through the night the next day consisting of tiredness, headache, every joint in my body in pain, chills, nausea, flu like illness, swollen lymph nodes in neck and arm pit area. Left arm pit lymph node was swollen to the size of a clementine and very painful. Swelling has gone down but still somewhat swollen and tender in that area 4 days later.
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| 62 | 2021-04-01 | musculoskeletal stiffness |
8 hours after injection: Stiffness in arm and sore at injection site - duration 48 hours 24 hours a...
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8 hours after injection: Stiffness in arm and sore at injection site - duration 48 hours 24 hours after injection: Slight fever - duration 8 hours Headache - duration 2 days 36 hours after injection: Rash on face - duration 3 days
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| 62 | 2021-04-03 | joint pain |
After 15 minutes of waiting and as we were leaving I started with a headache and had problems breath...
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After 15 minutes of waiting and as we were leaving I started with a headache and had problems breathing. By the time we reached the car, I felt worse and went back inside to the paramedics. At that time I was having heart palpitations, problems breathing, BP was 194/120, felt lightheaded and dizzy. Was having problems with walking. The next day I woke up and my hands were curled up, hips were sore, body aches, hard to walk shuffling instead of lifting feet.
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| 62 | 2021-04-03 | joint pain | Error: Shoulder Joint Injury (prolonged pain, tingling, etc.) |
| 62 | 2021-04-09 | joint pain |
Woke up on 3rd morning with excruciating hip pain, unable to bend; Woke up on 3rd morning with excru...
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Woke up on 3rd morning with excruciating hip pain, unable to bend; Woke up on 3rd morning with excruciating hip pain, unable to bend; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Dose 2) via an unspecified route of administration, administered in left arm on 23Mar2021,15:00 (batch/lot number: unknown) at 62 years old as SINGLE DOSE for COVID-19 immunization. The vaccine was administered in Other vaccination facility. The patient's medical history included MGUS (Monoclonal gammopathy of undetermined significance), Ehlers Danlis syndrome 3, and iodine allergy; all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Concomitant medications included clarithromycin (CLARI), estradiol (ESTROGEN), progesterone (PROGESTERONE), methylphenidate hydrochloride (RITALIN), and testosterone (TESTOSTERONE); therapy dates and indications for all were unspecified. The patient previously received the first dose of the BNT162B2 via an unspecified route of administration, administered in left arm on 02Mar2021 17:00 (batch/lot number: unknown) at 62 years old as single dose for COVID-19 immunization. Patient did not receive other vaccination within 4 weeks prior to the BNT162B2. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 26Mar2021 07:00, the patient woke up on 3rd morning with excruciating hip pain, unable to bend. It was unknown if patient received treatment as a result of the event. The patient has not recovered from the event. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 62 | 2021-04-14 | groin pain |
Started on April 1 I was hurting in m y grove area, Friday April 2 I went to the clinic I had my sho...
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Started on April 1 I was hurting in m y grove area, Friday April 2 I went to the clinic I had my shot at. They did a chest extra to make sure I didn?t, have a blood clot. When home on Saturday I could hardly walk and get up on my own. It would rotate to both hands and wrist couldn?t bend my fingers. Went to Dr took labs if need contact physian. Went to ER twice and gave me a steroid shot. Gave me pain medicine and medpack
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| 62 | 2021-04-15 | arthritis |
fluid like blister on roof of mouth, red dots on skin, extreme fatigue and worsening of arthritis sy...
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fluid like blister on roof of mouth, red dots on skin, extreme fatigue and worsening of arthritis symptoms and GERD
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| 62 | 2021-04-15 | muscle pain |
Pfizer-BioNTech COVID-19 Vaccine EUA: six days after immunization patient presents with shortness of...
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Pfizer-BioNTech COVID-19 Vaccine EUA: six days after immunization patient presents with shortness of breath, myalgias, cough, headache, and chest pain. Hospitalized with acute hypoxemic respiratory failure secondary to COVID-19 infection: administered steroids, antivirals, and anticoagulation. Patient currently hospitalized.
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| 62 | 2021-04-18 | neck pain, armpit pain, muscle pain, joint pain |
INFLAMMATION ALL LEFT SIDE OF BODY,PAIN IN LEFT ARM,SPREAD TO SHOULDERS,NECK AND RIGHT ARM,TACHYCARD...
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INFLAMMATION ALL LEFT SIDE OF BODY,PAIN IN LEFT ARM,SPREAD TO SHOULDERS,NECK AND RIGHT ARM,TACHYCARDIA,THROAT TIGHTENING,DIZZINESS ON STANDING,HEADACHE,FEVER,NAUSEA,UNBEARABLE MUSCLE PAIN,WEAKNESS ALL OVER BODY STILL TODAY,PAIN BETWEEN AXILLA AND LEFT BREAST,DECREASED APPETITE,I GET TIRED QUICKLY,AND EVEN TODAY,,NAUSEA,DIZZINESS BODILY WEAKNESS,HEADACHE,AND I STILL HAVE INFLAMMATION....I THOUGHT I WOULD DIE!!!!,THE ADVERSE REACTION WAS EXTREMELY HORRIBLE
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| 62 | 2021-04-21 | muscular weakness |
TIA - mini stroke/transient ischemic attack. Started with loss of ability to speak/understand, weakn...
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TIA - mini stroke/transient ischemic attack. Started with loss of ability to speak/understand, weakness of left arm and leg, headache, slurring of words - 3 days in Hospital - resulted in damage to memory, confusion, weakness in left arm+leg, severe headaches - ongoing, but slightly improved after 3 weeks. Also diagnosed with acute cerebrovascular accident.
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| 62 | 2021-04-23 | muscular weakness |
Husband said that she started having muscle weakness in arms and legs 3 days after the vaccine. Went...
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Husband said that she started having muscle weakness in arms and legs 3 days after the vaccine. Went to hospital after she declined. Has since been put on a Vent to help her breathe. Has been on a vent for 3 days and they are starting to wean her off of the vent now.
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| 62 | 2021-04-23 | muscle pain |
Tiredness; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient)...
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Tiredness; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6201), via an unspecified route of administration in left arm on 11Feb2021 at 17:45 as single dose for COVID-19 immunization. The medical history of patient was included asthma, high blood pressure, obesity, allergies from Penicillin. Patient did not receive any other vaccine in four weeks. The concomitant medications of patient included triamterene, trazodone, citalopram and potassium (Other medications in two weeks). On 12Feb2021 at 06:00 AM, patient experienced tiredness, headache, muscle ache. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient did not receive any treatment. The outcome of event was recovering.
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| 62 | 2021-04-24 | joint pain |
She was shaking, she thought she was having a seizure with how bad she was shaking; She was shaking,...
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She was shaking, she thought she was having a seizure with how bad she was shaking; She was shaking, she thought she was having a seizure with how bad she was shaking; Chills; Fever; sore hands and wrists; sore hands and wrists; totally exhausted; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 15:00 (Lot Number: EPT533) as single dose for covid-19 immunisation. The patient previously took flu shot. Medical history included diabeticc, thyroid is done, real bad psoriasis, high blood pressure, triglycerides, cholesterol , anxiety, to replenish potassium. Concomitant medications included metoprolol taken for hypertension; acetylsalicylic acid (ASPIRIN (E.C.)); citalopram taken for anxiety; amlodipine taken for blood pressure; hydrochlorothiazide; fenofibrate taken for blood triglycerides; atorvastatin taken for blood cholesterol; losartan potassium to replenish potassium; colecalciferol (VITAMIN D3); metformin taken for diabetes mellitus; levothyroxine; hydroxyzine; guselkumab (TREMFYA) taken for psoriasis,. The patient was shaking, she thought she was having a seizure with how bad she was shaking, chills, fever, sore hands and wrists, totally exhausted, diarrhea on 01Apr2021. The outcome of events chills, Wrist pain, Pain in hand was recovered on 05Apr2021; The outcome of event Fever and Diarrhea was recovered on 06Apr2021; outcome of other events was recovering.
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| 62 | 2021-04-26 | muscular weakness |
had a stroke after getting the Pfizer vaccine; weakness left arm and left leg; Headache; Dural venou...
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had a stroke after getting the Pfizer vaccine; weakness left arm and left leg; Headache; Dural venous sinus thrombosis; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 62-years of age) dose 2 via an unspecified route of administration, administered in arm right on 01Apr2021 10:20 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation (to not get Covid). Medical history included ongoing multiple sclerosis which was diagnosed back in the early 90's and the doctors saw no new reasons on any part of the MRI of the brain, neck, and spine, there were no new lesion and she has had no problems for 30 years; and she had sinus pressure. There were no concomitant medications. Historical vaccine included BNT162B2 (Batch/lot number: EN6208) dose 1 in her left arm on 11Mar2021 (at 61 years of age) for COVID-19 immunisation. It was reported that the patient had a stroke after getting the Pfizer vaccine. She stated that she was in the ICU for 3 days. They tested every part of her body and couldn't find a reason. She added that she had a clot in her brain with a small bleed and they told her it was highly unusual to happen in that part of the brain. It was stated that it was where the blood goes from the brain to the heart. She mentioned that it was a dural venous sinus thrombosis. She was in the neuroscience ICU for 3 days and her left leg and left arm are still weak and she will start PT. She wanted to talk about reporting and let us know this was happening and that the neuroscience team reported it to the CDC online while she was in the hospital. She wanted to talk about her concerns and see if we are seeing this with other people. She added that she was tested, and they found nothing. She mentioned that she got the vaccine in a Thursday morning and by Friday she had weakness in her left arm and left leg and a headache. She added that there was a high probability that it was related, that it was a new vaccine and it was hard to say it definitely happened from that but it was a high probability. She had other questions, she has heard from other people with other vaccines and people with Covid experience blood clots. She stated that she was wondering what if it was with the vaccine that is reacting to what it thinks is Covid, or is it the body's response. She was wondering if Pfizer comes out with a booster with the variant, should she not take the booster. She stated that it could have killed her if they had not caught the blood clot in her brain and had she not gone to the ER it could have killed her and she was concerned about taking a booster. She provided that she had the Pfizer vaccine on 01Apr2021 in the morning and had a headache that same day and who knows when on Friday morning she had weakness in her left leg and left arm, so within 24 hours. She provided that she went to the ER Saturday 03Apr2021, that she wasn't sure about it and you don't go running for everything. Stated she was admitted 03Apr2021 and was discharged 05Apr2021 or 06Apr2021. She clarified that her headache was totally gone, that she had sinus pressure that was not related and had it as a constant in her life, it was normal for her and happens with changes with the weather. The patient was hospitalized for had a stroke after getting the pfizer vaccine (cerebrovascular accident) from 03Apr2021 to 06Apr2021. The patient underwent lab tests and procedures which included blood work constantly, CAT scan of her torso, several CAT scans of her brain, had MRI's and CAT scans constantly, brain MRI, MRV of the brain all on an unknown date with unknown results. The events resulted from Emergency Room Visit. The outcome of headache was recovered on an unknown date while not recovered for weakness left arm and left leg. The outcome of other events was unknown. Information on the lot/batch number has been requested.
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| 62 | 2021-04-27 | joint swelling |
Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee...
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Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee; Leg was swelling/right shoe was tight; Lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; It was tender on her right leg on the left side of the tibia/It is very tender to the touch; Red mark on her leg with a little nodule; Red mark on her leg with a little nodule; Calf pain; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7533; Expiration date was not reported) on the right arm on 30Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic. Medical history included pain and headache. Concomitant medications included paracetamol (TYLENOL ARTHRITIS) for pain; hydrocodone for pain; amitriptyline for headache; and ongoing paracetamol (TYLENOL EXTRA-STRENGTH) for pain. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208; Expiration date was not reported) on the right arm on 11Mar2021 (when the patient was 62 years old) for COVID-19 immunization. On 07Apr2021, the patient's doppler showed a blood clot. On 30Mar2021, the patient had a really bad case of diarrhea; swelling in her knee; and leg was swelling/right shoe was tight. On 02Apr2021, the patient had pain behind her cast. On an unspecified date in 2021, the patient's lower extremity venous ultrasound showed right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; was tender on the right leg on the left side of the tibia that was very tender to the touch; had a red mark on her leg with a little nodule; and had calf pain. The events had resulted into an emergency room visit and physician's office visit. The patient had received treatment for the events, 'blood clot', 'lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein', 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'tender on her right leg on the left side of the tibia that was very tender to the touch'. The outcome of the events was recovered on 30Mar2021 for 'really bad case of diarrhea'; was recovering for 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'red mark on her leg with a little nodule'; and was unknown for all the other events.
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| 62 | 2021-04-27 | musculoskeletal pain, joint pain |
2 1/2 weeks after 1st dose, sharp pain in left buttock and down leg began. Continued and worsened s...
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2 1/2 weeks after 1st dose, sharp pain in left buttock and down leg began. Continued and worsened sharply after 2nd dose 4 days later. Now more than 3 weeks later, pain has intensified and centered in left buttock and left hip. Hip pain is constant, but extreme when going to a standing or sitting position. It is at its worst when bending down to pick up something, when carrying anything, when pulling my chair up to the table. I can no longer walk my dogs for the 1-2 miles a day I used to do. Picking up their feces is torture. I had 3 days this week where the pain lessened and I thought it was ending (04/25-4/27) but today is one of the worst days I?ve had. I can?t move without feeling sharp severe pain in my hip. Although I?ve had minor hip and sciatica pain on a few occasions, I?ve never been diagnosed with arthritis or sciatica. What I am feeling today seems extreme and arthritic in nature. I can press on the pain?s primary location on the top of my left hip. The pain inside my left buttock has returned as well.
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| 62 | 2021-05-05 | back pain |
Patient received COVID-19 vaccine on 1/28 and 1/6/2021. On 4/25 patient developed cough, back pain,...
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Patient received COVID-19 vaccine on 1/28 and 1/6/2021. On 4/25 patient developed cough, back pain, and weakness/fatigue. Tested positive for COVID. Treated with monoclonal antibodies.
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| 62 | 2021-05-10 | joint pain |
Major joint pain and inflammation in knees and ankles Major tiredness. Did not wake up on May 7. M...
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Major joint pain and inflammation in knees and ankles Major tiredness. Did not wake up on May 7. My husband had to call 911 as my Blood sugar dropped to a low of 17 I almost died
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| 62 | 2021-05-11 | bone pain, joint pain, back pain |
To check if it was blood clot; Intermittent long-lasting palpitations; Lymph discomfort in one leg; ...
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To check if it was blood clot; Intermittent long-lasting palpitations; Lymph discomfort in one leg; Severe pain of bones in chest; Joint pains; Severe shooting intermittent head pain; Cold sweat; Felt like she was going to faint; COVID arm popped out; Severe nerve pain behind ear same side as vaccine; Exacerbated back pain; Bad menstrual cramps; This is spontaneous report from contactable consumer (patient). A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 31Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included fibromyalgia, complex regional pain syndrome (CRPS), lymphedema (previously resolved), mild asthma, osteoporosis, herniated discs, allergies, and menopause. The patient's concomitant medications included unspecified vitamins. The patient had no other vaccine in four weeks (however, it was also reported that other vaccine was administered in same date, 31Mar2021; pending clarification). The patient was not diagnosed with COVID-19 prior vaccination. On 03Apr2021 at 02:00 AM, the patient experienced intermittent long-lasting palpitations, lymph discomfort in one leg for which they went to check if it was blood clot. On 03Apr2021 at 02:00 AM, the patient also had severe pain of bones in chest, joint pains, severe shooting intermittent head pain, cold sweat, felt like she was going to faint, COVID arm popped out (nite 8; as reported), severe nerve pain behind ear same side as vaccine, exacerbated back pain, and bad menstrual cramps for 2 mornings 11 years post-menopause. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the adverse events. The events were considered non-serious. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events. No follow-up attempts are needed. No further information is expected.
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| 62 | 2021-05-19 | weight decreased |
This is a spontaneous report received from a contactable nurse (patient) via a Pfizer-sponsored prog...
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This is a spontaneous report received from a contactable nurse (patient) via a Pfizer-sponsored program. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206), via an unspecified route of administration in the right arm, on 10Mar2021, as 1st dose, single, for COVID-19 immunisation. Medical history included ongoing fibromyalgia (diagnosed in 1996), ongoing allergies from 1981, ongoing food allergies and chemical allergies, ongoing allergy to alcohol, ongoing hypothyroidism from 2012, ongoing pre-diabetic from 2012, Lyme disease for 11 years before being correctly diagnosed and treated, concussion in Sep2019, and post concussion syndrome in Sep2019. The patient previously took nalbuphine hydrochloride (NUBAIN) in 1981 and experienced anaphylaxis; and paracetamol (TYLENOL) and was very sensitive, had rash and high blood pressure. Within the first 15 to 20 minutes following the administration of the first dose of the Covid-19 vaccine, on 10Mar2021, the patient's face and ears got very red, flushed, and itchy. The patient reported that she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction. She reported that she has had glycol before and has never reacted quite like that. The flushing, redness, and itchiness of her face and ears subsided within an hour and were gone by 4 hours. Her allergist instructed her to take 2 Zyrtec before getting the second dose of the Covid-19 vaccine. After her face and ears became flushed, red, and itchy, she ended up having a really bad headache that continued until the next day. Her headache was severe for about 12 hours and continued for a total of a day and a half. She stated that her headache was more like a migraine during the 12 hours when it was severe. It felt like a migraine, but worse. On 10Mar2021, the patient reported that she experienced flu-like symptoms like being nauseous, had dizziness, achiness all over, and was not feeling well, her post-concussion syndrome was triggered and had more headaches, dizziness, nausea. She reported that things have been going awry in her body since she had the COVID-19 vaccine. She reported that the increase in headaches seemed to have improved, but the nausea and dizziness have in some ways improved and then some days it feels like "here we go again" when it hits. About a week after she received the first dose of the Covid-19 vaccine, in Mar2021, the patient noticed a change in her urination. It wasn't severe or anything at that point, she just felt like she was not able to release the urine (urine retention). She thought to increase her intake to see if it would help her urinate and it didn't seem to help much. She received a prescription on 26Mar2021, and during that week, she noticed that she was having more issues with some burning during urination and was developing pelvic pain and pressure. The patient stated that the scent and color of her urine looked fine. She reported that the frequency started to increase with not much urine coming out. When she finished her antibiotics about 7 days later, the urine retention had really improved and went away at the end of March. In the morning of 26Mar2021, when the patient woke up, she had blood in her urine and clots. The clots were about the size of a pea and a couple were about the size of a dime. The blood and blood clots in her urine were what made her go to the doctor. She reported she has never had blood in her urine that she remembers. She was put on Macrobid for 5 days. She reported that Macrobid wasn't relieving enough of her symptoms and her provider ended up adding a couple more days. The patient reported feeling more worn out in Mar2021, since she received the first dose of the COVID-19 vaccine. This did not improve and some days it was worse. The patient did not have the energy level and stamina that she used to (Mar2021). She reported that whether it's combined with the retriggering of her post-concussion syndrome, it is significant for her life. She was also not eating well and had lost some weight (Mar2021). She reported that her appetite is improving but it is still not normal for her. She mentioned it was harder for her to want to eat something because of feeling nauseated. The patient assessed the events "face and ears became very flushed, red, and itchy", headache, "headache was more like a migraine/felt like a migraine, but worse", "post concussion syndrome was retriggered", "blood in her urine and clots", "not eating well and had lost some weight" and "feeling more worn out" as serious (medically significant). The patient recovered from "face and ears became very flushed, red, and itchy" and "she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction" on 10Mar2021; headache, "headache was more like a migraine/felt like a migraine, but worse", "she was not able to release the urine (urine retention)", "blood in her urine and clots", "flu like symptoms", dizziness, "achiness all over", "pelvic pain and pressure", and "some burning during urination" in Mar2021; and was recovering from "not eating well and had lost some weight". The outcome of the remaining events was unknown. The patient assessed the causality of events headache, flu like symptoms, nausea, "face and ears became very flushed, red, and itchy", dizziness, "post concussion syndrome was retriggered", and "not eating well and had lost some weight" as related to BNT162B2.; Sender's Comments: Based on the information in the case report and a plausible temporal association, A possible causal relationship between urinary retention, hemorrhage urinary tract and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 63 | 2021-01-06 | muscle pain |
Within 8 hours of vaccine receipt, I began to experience left-sided tinnitus. During the first vacci...
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Within 8 hours of vaccine receipt, I began to experience left-sided tinnitus. During the first vaccination; I experienced muscle soreness at the site of injection; mild fatigue the next day (12/14/2020). After the second vaccine, I experienced increased muscle pain, with decreased ROM of the left shoulder due to pain. Within 12 hours, I experienced diffuse myalgias. After 16 hours, I experienced a fever (101F) with chills (resolved within 24 hours). There was significant fatigue the first 36 hours after the second vaccine administration. I took two doses of Tylenol on the first day. No rash.
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| 63 | 2021-01-06 | muscle pain | Myalgia |
| 63 | 2021-01-06 | muscle pain |
Headache, Myalgia, CoughWheeze, Syncope, Fatigued, chills, night sweats, mild shortness of breath, c...
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Headache, Myalgia, CoughWheeze, Syncope, Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency. Tested + for COVID on 1/4/21 Narrative: Fatigued, chills, night sweats, mild shortness of breath, cough. Takes coumadin for protein s deficiency, sees hematology. Currently taking prn tylenol, scheduled to see hematology. Tested positive for COVID on 1/4/21.
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| 63 | 2021-01-07 | joint pain | pain in shoulder, decreased range of motion |
| 63 | 2021-01-07 | musculoskeletal stiffness |
Urinary tract infection; Injection site soreness/ Injection site pain; Achy; Headache; Sore on the i...
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Urinary tract infection; Injection site soreness/ Injection site pain; Achy; Headache; Sore on the injection arm; Her arm was stiff feeling; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL0140), intramuscular on 18Dec2020 15:00 at single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The transferring agent stated that she has a caller on the line that received the first dose of the Covid-19 vaccine on 18Dec2020. She is supposed to get the second dose tomorrow 06Jan2021. She developed a urinary tract infection over new years and was put on antibiotics. She wanted to know if she could get the second dose while on antibiotics. The transferring agent stated that the caller reported that she started feeling achy and had a headache, but did not think it was related to the shot. She stated that she had injection site pain and was sore on the injection arm. She had the shot late in the afternoon around 15:00 on 18Dec2020. She said that she was sore later on that evening at the injection site and her arm was stiff feeling the next day, but it was resolved by the day after. She said that the headache came and went. She treated it with Tylenol. She said that she did not feel real good most of the day on Saturday 19Dec2020, but by Sunday she was back to normal again. The outcome of the event Urinary tract infection was unknown while the outcome of the other events was resolved on 20Dec2020.
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| 63 | 2021-01-07 | muscle pain, joint pain |
Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: Is taking Ibuprofen/ Advil, also took Zof...
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Headache, Myalgia, Arthralgia & NauseaVomiting Narrative: Is taking Ibuprofen/ Advil, also took Zofran for nausea. Body aches are 10/10, sometimes improve down to 8/10.
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| 63 | 2021-01-07 | muscle pain, neck pain |
Her temp got up to, she think it was to '38.7'; Muscle ache but at the injection site for sure; Neck...
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Her temp got up to, she think it was to '38.7'; Muscle ache but at the injection site for sure; Neck pain; Chills; headache; This is a spontaneous report from a contactable nurse (patient). This 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK4176), via an unspecified route of administration, on 02Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 63-years-old. Medical history was none. Concomitant medications were unknown. Nurse stated she got her shot yesterday in the morning on 02Jan2021. So, she had had just muscle ache but at the injection site for sure and headache, neck pain and then last night starting around 6 O'clock fever and chills. Her temp got up to, she think it was to 38.7 (not clarified further) was when she finally tried to get out of bed to take it. So, she is taking Tylenol a 1000 mg around the clock every 6 hours. The patient is feeling much better but she doesn't want to go through another night like that. Outcome was unknown. For the reporting nurse fever and chills were related to the vaccine.
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| 63 | 2021-01-07 | muscle pain | fever, muscle aches,headache |
| 63 | 2021-01-08 | muscle pain |
Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taki...
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Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taking about 15 seconds to complete injection. Injection was painful. Within 1 hour I could not raise my arm more than 30 degrees without severe pain. Diminished ROM and pain at night is ongoing. Within 4 hours, I had a low grade fever with chills, headache and myalgia that persisted for 12 hours then respoved. I am awaiting an appointment with my primary care physician and will know then if more treatment will be recommended. Incident Report filed at the hospital.
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| 63 | 2021-01-09 | joint pain |
Patient woke up Saturday am and right foot felt like it was sprained, painful at ankle joint, slight...
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Patient woke up Saturday am and right foot felt like it was sprained, painful at ankle joint, slightly red. Sunday morning, she could not put any weight on right foot, more red/all toes red (except one), redness is traveling down right big toe, right foot appears slightly swollen.
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| 63 | 2021-01-12 | joint pain, back pain |
horrible body aches; Nausea; head fogginess; felt like a lump and couldn't move; not wanting to eat;...
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horrible body aches; Nausea; head fogginess; felt like a lump and couldn't move; not wanting to eat; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (Batch/lot number: E10140) first dose on 28Dec2020 11:15AM in the right arm at single dose since she is front line health care worker. Medical history included pain. Medical history included tramadol for pain. No Prior Vaccinations (within 4 weeks). Family Medical History Relevant to AE was none. She received the vaccine 28Dec2020 and it flattened her for two days. Her primary care provided has advised her not to take the next dose. Within 45 minutes she noticed nausea. She was eating lunch and she felt like everything was coming up and she forced herself not to vomit. The she noticed horrible body aches; head was foggy; she felt like a lump and couldn't move;. The body aches hurt in her arms, legs, hips, and back. Adds she was out of work for two days. She could feel it working as the symptoms would peak and then drop. She did go back to work but shouldn't have as she continued to feel nauseous and not wanting to eat. All of these symptoms have now resolved. Vaccination Facility Type was nursing home. No Vaccine Administered at Military Facility. Facility Name: Nursing Home. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Event not resulted in Physician office or ER. The outcome of the event nausea was recovered on 02Jan2021. The outcome of event not wanting to eat recovered on 03Jan2021. The outcome of other events was recovered on 01Jan2021. The seriousness criteria for event horrible body aches was reported as medical significant.; Sender's Comments: The patient had medical history included pain. A possible contribution role of the first dose of BNT162B2 to the horrible body aches cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-01-12 | armpit pain |
I developed a swelling in the right axilla, not a discrete node, but what felt like an accumulation ...
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I developed a swelling in the right axilla, not a discrete node, but what felt like an accumulation of fluid - lymph perhaps - about the size of a large lemon.
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| 63 | 2021-01-12 | muscle tightness |
temp of 101.8 at 11:00pm on 1/11/2021. Woke up at 4:00am on 1/12/2021 with muscle cramps in both leg...
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temp of 101.8 at 11:00pm on 1/11/2021. Woke up at 4:00am on 1/12/2021 with muscle cramps in both legs; aching all over and headache and body aches ; fatigue and extreme muscle tenderness in left arm (site of injection) Temp remained at above 100.0 even with Tylenol and headache and body aches until 9:00pm. Woke up on 1/13/2021 with only symptoms being sore arm; slight headache and muscle tightness in neck.
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| 63 | 2021-01-12 | muscular weakness |
Starting on 1/8 she began having headaches and weakness in her legs. On 1/9 the headache got worse, ...
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Starting on 1/8 she began having headaches and weakness in her legs. On 1/9 the headache got worse, she had a COVID test which was negative. On 1/11 she had vomiting for hours after taking Tylenol. On 1/13 she still has a headache, but also SOB and body aches
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| 63 | 2021-01-12 | muscle pain |
Muscle soreness, injection site pain/swelling, tongue numbness, fever, headache and violent tremors ...
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Muscle soreness, injection site pain/swelling, tongue numbness, fever, headache and violent tremors to all extremities (for about 10 mins) and chills the night after getting the vaccine. tongue numbness happens to her at baseline at times, this has subsided The tremors started after stretching her arms, they stopped shaking after about 10 mins after she laid in bed. Temp was about 100-101.2 through the night Has not taken any medications for this.
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| 63 | 2021-01-13 | joint pain, muscle pain |
Chills; headache; nausea; diarrhea; muscle and joint pain; muscle and joint pain; strange coffee tas...
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Chills; headache; nausea; diarrhea; muscle and joint pain; muscle and joint pain; strange coffee taste; This is a spontaneous report from a contactable Nurse (patient). A 63-year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 05Jan2021 14:30 on right arm at a single dose for COVID-19 immunization. The patient known allergy included Penicillin allergy and other medical history included Diabetes 2, Hypertension, Reynauds and obesity. There is no other vaccine in the four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications in two weeks included losaeten, metformin, hydrochlorthiazide, duloxetine hydrochloride (CYMBALTA). The patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Dec2020 14:30 on left arm at a single dose for COVID-19 immunization. The patient experienced chills, headache, nausea, diarrhea, muscle and joint pain, strange coffee taste on 06Jan2021 02:00 and result in doctor or other healthcare professional office/clinic visit. No treatment received for these adverse events. The patient did covid test post vaccination via Nasal Swab on 07Jan2021 and result negative. The outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 63 | 2021-01-17 | joint pain, muscle pain |
1/6 THROUGH 1/10: SEVERE HEADACHE, NAUSEA, CHILLS (OVERWHELMING), JOINT PAIN, FEVER (100), MUSCLE AC...
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1/6 THROUGH 1/10: SEVERE HEADACHE, NAUSEA, CHILLS (OVERWHELMING), JOINT PAIN, FEVER (100), MUSCLE ACHES. TOOK TYLENOL.
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| 63 | 2021-01-17 | bone pain, muscle pain |
fever 99.4; muscle and bone aches; muscle and bone aches; wasn't feeling good; This is a spontaneous...
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fever 99.4; muscle and bone aches; muscle and bone aches; wasn't feeling good; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248 and expiry date: unknown), via an unspecified route of administration on 09Jan2021 15:50 at a single dose for COVID-19 immunization. Medical history included menopausal, GERD, sinus disorder, and allergies. Concomitant medications included colecalciferol (VITAMIN D 3) taking for a year or two for menopausal, cyanocobalamin (VITAMIN B12) taking for a year to help with hair, nail, and immune system, calcium taking for a year for supplementation and menopausal, famotidine taking for a year for GERD, fexofenadine hydrochloride (ALLEGRA) taking for a year for sinus and alllergies, and unspecified multivitamin taking for 5 years at least for iron supplementation. The patient received the first dose of bnt162b2 (lot number: EJ1685) on 19Dec2020 at 16:15PM in the left arm. She had a very sore left arm for a day and it swelled up a little. She felt some fatigue a little the next day on 20Dec2020 Sunday but it didn't prevent her from going to work. 20Dec2020 to 21Dec2020 (Sunday to Monday), she noticed a low grade fever for maybe 12 hours but she couldn't find a thermometer and did not know her temperature. She developed a reddening on her face, but it was not very pronounced, on the nasal labial area or smile line area. It was more pronounced on the first dose, she noticed it for about 8 to 12 hours Sunday 20Dec2020. All of her symptoms resolved by 21Dec2020. She received the second dose 9Jan2021 at 15:50PM in the left arm. She noticed nothing right away but maybe 6 hours later, her left arm was very sore. She had more of a fever which she measured at 99.4 Fahrenheit on 10Jan2021. Her normal is 97.1 to 97.5 Fahrenheit which she knew because she had to get screened at work. This time, after the second dose, she also noticed she had bone and muscle aches but was all short lived on 10Jan2021. She went to church and wasn't feeling good from about 10:00AM to about 19:00PM. She did treat the fever and muscle/bone aches with Tylenol extra strength rapid relief 500mg each. She took two by mouth once 3 hours before the vaccine and again once during the night and once yesterday 10Jan2021 afternoon for a total of three times and it did help. She also rested on Sunday 10Jan2021 afternoon, took extra fluids so by the time she had to go to work she felt normal. The vaccine was not administered at military facility. No additional vaccines were administered on same date of bnt162b2. The adverse events did not require a visit to the physician's office or ER. There were no prior vaccinations (within 4 weeks). The patient had no family medical history relevant to the adverse events. Outcome of the event wasn't feeling good was unknown and of the other events was recovered on 10Jan2021.
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| 63 | 2021-01-18 | joint pain | Fever (100.2 degrees), fatigue, headache, joint pain, chills |
| 63 | 2021-01-18 | joint pain | Fever, fatigue, joint pain, dizziness, headache |
| 63 | 2021-01-18 | back pain |
10:00am - Vaccine given. 10:15am - client reported experiencing nausea & headache (pain scale: 8/10)...
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10:00am - Vaccine given. 10:15am - client reported experiencing nausea & headache (pain scale: 8/10). BP - 172/85mmHg; Pulse - 94). 10:18am - BP - 176/93mmHg; Pulse - 104 10:20am - BP - 186/93mmHg; Pulse - 105, client reports the pain and nausea symptoms are the same. Client taken to an exam room and placed lying down on her left side, head slightly elevated. Client reported feeling a bit cold, covered with disposable gowns for warmth. Temperature taken at 10:34am - Temperature: 37 degrees Celsius. 10:43am - BP 130/60mmHg, Pulse - 92. Client reported that feelings of nausea is gone, however is still experiencing slight headache 4/10 pain scale. 10:57am - BP 124/64mmHg; Pulse - 88 10:59am - BP 174/89mmHg; Pulse - 99. Client reports that she feels a sharp pain on her abdominal area by the belly button (6/10). Also reports a mid-back pain (9/10 pain scale). 11:10am - BP 162/86mmHg; Pulse - 101 11:15am - BP 147/78mmHg; Pulse - 89. Client reports abdominal pain at 5/10, mid-back pain 8/10. 11:25am - BP 155/82mmHg; Pulse - 90. Client reports abdominal pain is aching at 5/10 pain scale, mid-back pain 7/10 pain scale.
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| 63 | 2021-01-18 | limb discomfort |
Pt had heavy feeling in her feet followed by a choking feeling in her throat. Also noted tingling in...
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Pt had heavy feeling in her feet followed by a choking feeling in her throat. Also noted tingling in hands and feet.
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| 63 | 2021-01-18 | musculoskeletal stiffness |
12/29 vaccine 10:45. Twenty minutes after vaccination, breathing fast, stiffness in L neck. L sided ...
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12/29 vaccine 10:45. Twenty minutes after vaccination, breathing fast, stiffness in L neck. L sided weakness; transported to ER. I couldn't lift left leg, 1" off bed and couldn't do the push pull. 1-2 hours symptoms lasted. Everything went back to normal, sent home. 12/30 huge flare up with fibromyalgia; lasted couple days. Flare up occurred the following week. Getting second shot 1/19/2021
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| 63 | 2021-01-18 | neck pain |
from 1201 am to 0515 am on 1/7/21--headache, neck pain, cold hands/feet, chills, nausea, low grade f...
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from 1201 am to 0515 am on 1/7/21--headache, neck pain, cold hands/feet, chills, nausea, low grade fever (99 degrees) treatment taken at 0515 am --1 dramamine, 2 tylenol 0800 am- headache, temp 98.3 0915 am- headache treatment- 1 advil pm 0815 pm- temp 99, chills treatment- tylenol 3 days post vaccine- headache, nausea (treatment advil pm, dramamine) 6 days post vaccine- headache, nausea (treatment advil pm, dramamine) 9 days post vaccine--headache, nausea (treatment advil pm, dramamine)
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| 63 | 2021-01-19 | muscle pain |
Muscle pain throughout torso; Sore throat; Head ache that comes and goes; This is a spontaneous repo...
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Muscle pain throughout torso; Sore throat; Head ache that comes and goes; This is a spontaneous report from a contactable consumer reporting for herself. A 63-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL3246), via an unspecified route of administration, on 06Jan2021 at 12:00 AM, at single dose, for COVID-19 immunisation. Medical history included allergy to some antibiotics. Concomitant medications were not reported. Patient did not have COVID-19 prior to vaccination. The patient experienced muscle pain throughout torso, sore throat and head ache that comes and goes all on 09Jan2021 at 07:00 PM with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab): negative on 07Jan2021.
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| 63 | 2021-01-19 | muscle pain |
redness, itching swelling, warmth at site, muscle aches, fatigue evaluated by MD, tx with pepcid, Ty...
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redness, itching swelling, warmth at site, muscle aches, fatigue evaluated by MD, tx with pepcid, Tylenol, Claritin,Zyrtec began 01/19/2021 with mild relief
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| 63 | 2021-01-20 | joint pain, muscle pain | Pain at injection site, headache, chills muscle aches, joint pain, restless |
| 63 | 2021-01-20 | back pain | pain all over her body, she has inflammation in back for 48 hours, still having pain in back |
| 63 | 2021-01-21 | muscular weakness |
As I was sitting at my computer and suddenly I could barely keep my eyes open, I was so tired I coul...
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As I was sitting at my computer and suddenly I could barely keep my eyes open, I was so tired I couldn't lift my arms and once I closed my eyes, I could not muster the strength to open them. I felt like I was going to faint and then I got nauseated and I knew I was going to throw up. With my husband's help, I did manage to get to the bathroom (about 6 steps away). I threw up and immediately sat down in the nearest chair. I threw up a second time into a vessel after that. I then got a massive headache and chills. I could barely walk with assistance up the stairs to go to bed. I have never been more fatigued. After going to bed, I slept all night and woke the next day still fatigued, but nothing like the night before. I was able to work, even though I felt really tired. I did not have much of an appetite all day and two days later, I still feel fatigued.
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| 63 | 2021-01-23 | muscle pain |
Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taki...
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Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taking about 15 seconds to complete injection. Injection was painful. Within 1 hour I could not raise my arm more than 30 degrees without severe pain. Diminished ROM and pain at night is ongoing. Within 4 hours, I had a low grade fever with chills, headache and myalgia that persisted for 12 hours then respoved. Incident Report filed at the hospital. MRI done on 1/20/2021-saw Doctor on 1/22/2021 who diagnosed adhesive capsulitis.
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| 63 | 2021-01-24 | joint pain, bone pain |
Extreme bone pain, joint pain, hand pain, skin tenderness, headache, nasal stuffiness, chills. Extr...
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Extreme bone pain, joint pain, hand pain, skin tenderness, headache, nasal stuffiness, chills. Extreme pain lasted from 0140- 0500, but continued with the skin tenderness, chills, headache and joint pain. Took Tylenol. Got up once and thought I would pass out. Started resting some around 7am. Drank plenty of fluids. Drained all day. Saturday morning headache, nasal congestion, joint pain, hard to get out of bed. Drained all day. Sunday feeling better, but lethargic. Monday back to work.
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| 63 | 2021-01-24 | joint pain, muscular weakness, musculoskeletal discomfort |
lost muscle capacity of her arm/cannot lift a gallon of milk in the fridge/Right arm lost muscle cap...
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lost muscle capacity of her arm/cannot lift a gallon of milk in the fridge/Right arm lost muscle capacity; headache; terrible pain in her right elbow; joint discomfort; feeling achy in her right arm and all over; feeling achy in her right arm and all over; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL1284), via an unspecified route of administration on 06Jan2021 14:30 at single dose for covid-19 immunisation. Medical history included hypothyroidism, cholesterol. Concomitant medication included levothyroxine, atorvastatin. Patient on the line calling about the COVID 19 Vaccine on Wednesday in her right arm. Her right arm lost muscle capacity, she cannot lift, she cannot even lift a gallon of milk in the fridge. This has improved, but she still cannot use it normally. Thursday she was feeling achy; Friday she had a headache. Later that day she had the most terrible pain in her right elbow. It was excruciating pain. The next morning pain subsided. However, she does not have her full arm strength back yet. She confirmed she is a HCP. She also added, she works at the hospital. It is like a centralized monitoring system where she watches monitors connected to the care unit and since she has background as a HCP she alerts the nurses when there is an issue. She clarified her right arm lost muscle capacity was noticed on Friday 08Jan2021. She got the vaccine on 06Jan2021 and was able to drive home and it was fine. The next day, 07Jan2021 she was achy, like flu like, with joint discomfort that she normally does not have even though she is getting older. She was feeling achy in her right arm and all over. The achiness all over resolved Thursday or Friday. She confirmed she has recovered completely. On Friday 08Jan2021 she had a headache that would just not go away. The headache was not in the front, back, or above eyes so she knows it was not sinuses. The headache lasted all day. Stated by the next morning the headache was gone. Her head is fine. She confirmed she has recovered completely. She later added, even though she is getting older and forgets things. No additional details provided. She was supposed to go to work on Friday, but she was not quite miserable, but she just could not bring herself to go into work. She called out because of the headache and the arm pain had started to kick in. The outcome of the event Muscle weakness upper limb was resolving, joint discomfort was unknown, while the outcome of the other events was resolved in Jan2021.
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| 63 | 2021-01-24 | joint pain, muscle pain |
Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, s...
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Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, swollen lymph nodes, difficulty breathing, swelling of face, fast hearbeat, bad rash , dizziness and weakness, intestinal pain. All symptoms lasted 18 days. Was given prescription medication for symptoms by primary care doctor.
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| 63 | 2021-01-24 | joint pain | PAIN ON SHOULDER IN NECK SWELLING GANGLIOS. SINTOMES FOUR DAYS. |
| 63 | 2021-01-25 | back pain |
Cold like symptoms such as runny nose, stuffy nose, sneezing,,,,, severe back pain. Cold symptoms...
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Cold like symptoms such as runny nose, stuffy nose, sneezing,,,,, severe back pain. Cold symptoms were done morning of the 26th and back pain lessened by that afternoon.
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| 63 | 2021-01-25 | weight decreased |
lost a lot of weight, but still plump; tightness in chest; Upper chest tightness with post nasal dri...
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lost a lot of weight, but still plump; tightness in chest; Upper chest tightness with post nasal drip, like the flu; got Covid virus/ Covid PCR testing: positive; got Covid virus/ Covid PCR testing: positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EJ1685) via an unspecified route of administration on left arm on 24Dec2020 11:00 at single dose for COVID-19 immunisation. Medical history included ongoing asthma, ongoing allergies. She was asthmatic and believed that the virus would have affected her differently if she didn't get the vaccine. If she was to catch the virus and didn't have the vaccine she may not have come out of it. The patient's concomitant medications were not reported. The patient denied getting any other vaccines that day or 4 weeks prior. No problems with vaccines in past. Received the COVID vaccine at her workplace. The patient got COVID virus on 07Jan2021. It was also reported that the patient lost a lot of weight, but still plump, coughing, tightness in chest, upper chest tightness with post nasal drip, like the flu, body aches, all on an unspecified date. Emergency room visit needed for the events (body aches, runny nose). The patient underwent lab tests and procedures which included Covid PCR testing: negative on 04Jan2021, positive on 07Jan2021, rapid COVID testing: negative on 01Jan2021. The outcome of the event (got COVID virus) was not recovered, of other remain events was unknown. Clinical course: The patient received the first dose of BNT162B2 on 24Dec2020, and a couple weeks later she got the COVID virus (07Jan2021). Mentioned she lost a lot of weight, but still plump. Probably be in the hospital now. Still had some coughing, tightness in chest, but it's not as bad. Upper chest tightness with post nasal drip, like the flu, runny nose in throat that goes down into the lungs and when it goes down she coughs and hacks to get rid of it. Went to the doctor office on the 01Jan2021 and did a rapid test and it was negative. Then on 04Jan2021 she did another PCR Covid test and it was negative. On 07Jan2021 she had symptoms and was insistent on getting another test since having body aches, runny nose. Got the re-test and it came back positive when she went to the emergency room. Got the PCR test. The patient thought that the way they were testing is how it's spreading. Did the testing on the 04Jan2021 and they used a swab bigger than a cue tip, it was huge and couldn't get far up enough instead of the tiny ones. On the 07Jan2021 at her job, emergency room, they had the tiny ones and was able to go further up and that's when she tested positive. Mentioned using salbutamol (ALBUTEROL) nebulizer, over the counter cough syrup, prescription azelastine hydrochloride;fluticasone propionate (DYMISTA) nasal spray, and pseudoephedrine hydrochloride (SUDAFED). When has the dry cough she uses the ALBUTEROL nebulizer with the machine and vials at home and that slows down the coughing a lot and the other stuff with the lungs. Not taking any steroids. Using SUDAFED to stop the runny nose from post nasal drip from going into lungs.
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| 63 | 2021-01-26 | joint pain |
428801 - Number given on Vaccination log - that day of the Vaccination dose 2. (Patient stated short...
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428801 - Number given on Vaccination log - that day of the Vaccination dose 2. (Patient stated shortness of breath was another symptom that she had from COVID and is continuing somewhat especially when I was a mask for work - but had not put it in the first report). Chills on Friday morning in the middle of night; woke up and my temp was 101.3 and I was feeling bad all day; had headache and went back to bed. Still have pain in hip/knee and joints and those pains got really bad after the vaccine - increased. Doctor vist told me to use Ibuprofen to 3 times a day for that pain. Shortness of breath continues from Covid symptoms and so does the hip/joint pain - it has decreased.
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| 63 | 2021-01-26 | back pain, muscle pain, joint pain |
About 5:30 or so and I was going to go to lunch at work - I felt like a heartburn and I was looking ...
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About 5:30 or so and I was going to go to lunch at work - I felt like a heartburn and I was looking for a tums. I didn't have any. I asked a coworker because my chest felt like I had heartburn. It was really bad. Protonic - a coworker gave it to me to see if that would help. And I took it. Diaphoretic - sweating - coworker noticed that I was sweating. I had pain in my jaw. I thought I was showing signs of a heart attack. A doctor came over and we told her what was happening with me. He recommended that I should be seen right away. Next thing I know, nurse is wheeling me down to ER in wheelchair as my chest pains weren't going away but ER told me I had to go through triage and wait. Finally got seen and I had an EKG - which was good. CDU unit - was admitted to and checked Troponin levels and did blood work. Everything came back fine. My EKG was being monitored all night. At one point I was feeling something and they gave me a dose of Nitro. It gave me a headache. There all night and then I did a stress test in the morning. And I was released that day. That was my day off so I was off all work. I went back to the work the day after. My granddaughter came to stay with me over Christmas and she started having symptoms of COVID. She wasn't feeling well. /She tested positive.Symptoms for COVID began for me on December 26th and was tested for COVID on December 27th - cough; sore throat; headache, fever, not got chills or lose my taste or smell (until after those symptoms were finished); belching - lots; diarrhea; upset; nausea. Extremely tired and muscles aches, joint pain - settled in my lower back and my hip. I still struggle with those joint pain and tiredness today. They put me off work until January 12 2021. I was scheduled to get the dose 2 at 9th but didn't get it that day because of COVID illness.
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| 63 | 2021-01-26 | muscle pain | Sudden onset of chills and shakes for about 6 hours, headache, stomach distress, muscle aches, |
| 63 | 2021-01-26 | neck pain, musculoskeletal stiffness, joint pain |
: 01.25.21, 1st day of vaccination Both sides of neck, lots of pain along with hard time turning...
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: 01.25.21, 1st day of vaccination Both sides of neck, lots of pain along with hard time turning neck with stiffness . 2nd day Chills, headache. Joints are in pain along with other body pain, nausea. Now, fever 99.1. 3rd day is today, 01.27.21, voice is affected, fatigued body is very achy.
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| 63 | 2021-01-28 | joint pain, muscle pain |
Severe chills, painful glands especially under L arm, fever (low grade, never over 100.5), muscle ac...
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Severe chills, painful glands especially under L arm, fever (low grade, never over 100.5), muscle aches and weakness, joint pain, severe head ache, nausea, extreme fatigue and slight confusion. Started about 11 hourse post injection and symptoms lasted 20 hours. Acetaminophen and increased water intake. Intermittent bedrest. Missed a day of work. Then suddenly everything cleared and I was wide awake and clear headed, just a little weak in muscles.
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| 63 | 2021-01-28 | armpit pain |
Intermittent fever; chills; body aches; tiredness; pain and swelling in a axilla area of left arm; p...
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Intermittent fever; chills; body aches; tiredness; pain and swelling in a axilla area of left arm; pain and swelling in a axilla area of left arm; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration in left arm on 12Jan2021 at 07:00 at single dose for COVID-19 immunization. Medical history included hypertension and ventricular septal defect. The patient was not pregnant. Patient has no COVID-19 prior to vaccination. Concomitant medications included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]), docusate sodium (COLACE), losartan, omeprazole and montelukast sodium (SINGULAIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685), via an unspecified route of administration in left arm on 22Dec2020 at 2PM for COVID-19 immunization. On 12Jan2021 at 11:30 PM, the patient experienced intermittent fever and chills, body aches, tiredness, and pain and swelling in the axilla area of left arm. Patient has not tested for COVID-19 post vaccination. The outcome of the events was recovering.
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| 63 | 2021-01-28 | flank pain, joint pain |
heaviness in chest with right flank pain; lots of phlegm; Pulse oximeter 89%; difficulty breathing h...
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heaviness in chest with right flank pain; lots of phlegm; Pulse oximeter 89%; difficulty breathing heaviness in chest/Shortness of breath; difficulty breathing heaviness in chest/ heaviness in chest with right flank pain; Chills; Sensitive skin; Super Thirsty; Fever 100.7/Low grade fever 99.9/ Low grade fever 99.0; Joint Pain; Congestion; Right arm injection site severe pain; This is a spontaneous report from a contactable other healthcare professional (Patient). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration on 06Jan2021 10:30 at single dose in Right arm for COVID-19 immunization. Medical history included hypertension. Concomitant medication included benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ, 10-12.5 MG Tablet), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chlorine, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine hydrochloride, tocopherol, vanadium, zinc (CENTRUM SILVER). The patient previously took codeine and experienced allergy. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient did not have covid-19 tested post vaccination. On 06Jan2021 20:00, the patient experienced Fever 100.7, Joint Pain, Congestion, Right arm injection site severe pain. On 07Jan2021, the patient experienced Chills, Fever 100.7, Sensitive skin, Super Thirsty. On 08Jan2021, the patient had Temperature 98.8, No Chills, Thirsty. On 09Jan2021, the patient was Some relief, no fever, no chills, no joint pain. On 10Jan2021, the patient experienced low grade fever 99.9, Pulse oximeter 89%, difficulty breathing heaviness in chest. On 11Jan2021, oxygen was 92%, Low grade fever 99.0. On 12Jan2021, vital signs stable no fever 97.7, oxygen 96%. On 13Jan2021, Vital Signs stable. On 14Jan2021, the patient experienced Shortness of breath, heaviness in chest with right flank pain, lots of phlegm, Temperature 98.0, Oximeter 96%. Coricidin HBP taken to relieve Congestion. Therapeutic measures were taken as a result of all reported events. The outcome of event chills was recovered on 08Jan2021, outcome of event Fever (event onset date: 06Jan2021 20:00) was recovered on 09Jan2021, outcome of event Low grade fever (event onset date: 10Jan2021) was recovered on 12Jan2021, outcome of event Joint Pain was recovered in Jan2021. The outcome of the other events was recovering.
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| 63 | 2021-01-28 | flank pain, back pain |
dysuria, abdominal, pelvic, left flank, upper and lower back pain. bladder spasms, urinary frequency...
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dysuria, abdominal, pelvic, left flank, upper and lower back pain. bladder spasms, urinary frequency, headache, vision changes, loss of appetite, dysphagia and fatigue
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| 63 | 2021-01-28 | limb discomfort |
starting on 1/19: headache; burning behind eyes and sore throat; x 3 days which have now resolved -...
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starting on 1/19: headache; burning behind eyes and sore throat; x 3 days which have now resolved - now dizzy when standing; fatigue - arms feels heavy when taking shower; pale; remains very weak and tired; dizzy - feels like anemia - tried to work last night but broke out in cold sweat and pale so sent home from work last night - sxs are not worsening
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| 63 | 2021-01-28 | muscle tightness |
8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest...
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8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest; tightness bilateral flank area; HA; body aches; diaphoresis; hot feeling; numbness tingling of head; numbness tingling of head/tingling in jaw and over the top of my head; pressure in the back of my neck; blurred vision; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in right arm on 14Jan2021 10:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Medical history included HTN, GERD, constipation, ocular migraine, osteoarthritis in sacroiliac joints, small fiber neuropathy, glucose intolerance, steatotic liver, CTS (Carpal tunnel syndrome). Concomitant medication included losartan (LOSARTAN), furosemide sodium (LASIX [FUROSEMIDE SODIUM]), and spironolactone (SPIRONOL). The patient previously received the first dose of bnt162b2 on 24Dec2020 10:00 AM for COVID-19 immunization. On 14Jan2021 11:00, the patient experienced tightness in chest tin which the patient took benadryl 25 mg with improvement, tightness bilateral flank area, HA, body aches, diaphoresis, hot feeling, numbness tingling of head, pressure in the back of my neck, and blurred vision. On 15Jan2021, the patient had an 8/10 chest pain radiating into left arm subsided after 10 mins, tingling in jaw and over the top of head, chest tightness and tightness in both flanks most of day 2. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162B2 administration to the event chest pain cannot be excluded. The status of medical history including HTN, GERD, constipation, migraine and osteoarthritis in sacroiliac joints would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-01-28 | musculoskeletal discomfort |
2 to 3 days of hip discomfort; unable to sit for any length of time, or lay on side for any length o...
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2 to 3 days of hip discomfort; unable to sit for any length of time, or lay on side for any length of time; This is a spontaneous report from a contactable nurse (reporting for herself). A non-pregnant 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK4176), via an unspecified route of administration, on 08Jan2021 11:00 at a single dose for COVID-19 immunization. The patients medical history was not reported. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), curcuma longa root (TURMERIC CURCUMIN), calcium pantothenate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B COM) , polycarbophil calcium (FIBER). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), on 18Dec2020 at 11:00 AM in the left arm for COVID-19 immunization. The patient has no known drug allergies. The patient experienced, 2 to 3 days of hip discomfort; unable to sit for any length of time, or lay on side for any length of time on 09Jan2021 07:30. No treatment was received for the event. The outcome of the event was recovered in Jan2021.
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| 63 | 2021-01-28 | muscle pain |
Muscle had severe burning sensation along with a peculiar feeling, like shards of glass embedded com...
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Muscle had severe burning sensation along with a peculiar feeling, like shards of glass embedded comes and goes but enough to interfere with daily living and movement
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| 63 | 2021-01-29 | joint pain |
Late evening after shot felt like was getting a cold, runny nose, tired. Next day had fever, high o...
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Late evening after shot felt like was getting a cold, runny nose, tired. Next day had fever, high of 100.0 F, joint pain, headache, fatigue. Lasted about 24 hours, improved by second day after shot with minor fatigue for another day, by 3rd day felt normal.
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| 63 | 2021-01-29 | muscle pain |
Pt received her 2nd dose of the pfizer vaccination on 1/29/2021 and 5 hours later, developed a fever...
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Pt received her 2nd dose of the pfizer vaccination on 1/29/2021 and 5 hours later, developed a fever of 102F, muscle aches and had a syncopal episode.
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| 63 | 2021-01-30 | muscle pain | mild headache, chills, nausea, muscle and body aches |
| 63 | 2021-01-31 | armpit pain, groin pain, flank pain |
Starting 12 hours after the injection she had a fever of 101.5 degrees F lasting over 20 hours. She ...
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Starting 12 hours after the injection she had a fever of 101.5 degrees F lasting over 20 hours. She also experienced severe body aches, flank pain, bilateral groin and axillary nodal pain.
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| 63 | 2021-01-31 | muscle pain |
The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions...
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The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions and some tingling at the injection site about 30 minutes after vaccine. Around 9:00 pm I started feeling weak and muscle aches all over, so went to bed. Around 2:00 am on 1/31/21 I woke up in pain all over my body muscle ache, headache, and difficulty walking. Took temperature 99 and my average temp is 97.9. I took one extra strength Tylenol. On 01/31/21 I just felt bad all day felt like COVID symptoms but no breathing difficulties just bad headache all day, weakness, entire left side my body left arm, left side chest, left leg hurt worse than right side. I?ve just treated with extra strength Tylenol and rest. Last night temperature was still 99, but sleep through the night. Today, February 1 still weak, ache all over, mild headache, and some pain on my left side body. I have not sought emergency treatment as if the date/time of report. I?m a healthcare worker taking today and tomorrow off work to recover.
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| 63 | 2021-01-31 | muscle pain |
Pfizer-BioNTech COVID 19 vaccine EUA- 7.5 hours after vaccine severe chills for 4 hours. Severe mus...
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Pfizer-BioNTech COVID 19 vaccine EUA- 7.5 hours after vaccine severe chills for 4 hours. Severe muscle aches for 22.5 hours.
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| 63 | 2021-02-01 | joint pain, arthritis |
odd taste in her mouth; arthritis; Yesterday I couldn't walk, my hip hurt me so bad. It still hurts ...
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odd taste in her mouth; arthritis; Yesterday I couldn't walk, my hip hurt me so bad. It still hurts now; Yesterday I couldn't walk, my hip hurt me so bad. It still hurts now; Yesterday I couldn't walk, my hip hurt me so bad. It still hurts now; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL3246), via an unspecified route of administration on 18Jan2021 around 7am in the right arm at single dose for COVID-19 immunization in hospital. Medical history included her hip usually bothered she, she could stand up, took a second then she could just go and put weight on it, and it would hurt the patient if she had been sitting for a long time. Family Medical History Relevant to AE was none. The patient's concomitant medications were reported as none. No history of all previous immunization with bnt162b2 considered as suspect. No additional vaccines administered on same date of bnt162b2. No prior vaccinations within 4 weeks. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140) on 28Dec2020 in the right arm at single dose for COVID-19 immunization at the age of 63-year-old; first dose of shingles shot (varicella zoster vaccine) for immunization; with the second shingles shot she had a reaction, not the first, it was the varicella zoster vaccine rge (cho) (Shingrix) and was done in 2019 for immunization. It was reported that patient got her second vaccine this morning (18Jan2021) and after eating lunch she had an odd taste in her mouth. She didn't think that was a side effect but want to check and make sure. She questions whether this was a side effect or in her head. It was still going on but not as bad as it was, it might be her imagination. Patient remarked that the more she was talking the better it was getting, the odd taste in her mouth. This event was not required a visit to Emergency Room or Physician Office. Patient further reported that several hours after having her shot on 18Jan2021 she had a problem with her left hip. A while before she had a doctor told her she had arthritis on 18Jan2021 and then another doctor told her that she didn't. When her hip usually bothered she, she could stand up, took a second then she could just go and put weight on it. And it would hurt her if she had been sitting for a long time. But this time it's lasting a long time. 18Jan2021 she couldn't walk, her hip hurt so bad. It still hurts now. She could stand up, but she couldn't put weight on it. 18Jan2021 her symptoms when she ate something, she got a really weird taste in her mouth. When she ate her lunch 19Jan2021, she didn't feel quite right so she stopped eating. She came back to her food a little later and everything was fine. Patient clarified that the weird taste in her mouth form 18Jan2021 has resolved. No investigation assessment. The outcome of event odd taste was recovered on 19Jan2021; outcome of the other events was unknown.
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| 63 | 2021-02-01 | back pain, bone pain | severe bone pain, arms, back pain, hands, and fingers. |
| 63 | 2021-02-01 | muscle tightness |
Loss of taste; Tightening in the jaw; Tightening is on the side where the forehead is and the front ...
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Loss of taste; Tightening in the jaw; Tightening is on the side where the forehead is and the front like on the two sides is the pressure on the side of the head; just thinking of a headache; I have been feeling lot of fatigue; crying; This is a spontaneous report from a contactable consumer. This consumer reported for herself that the 63-year-old female patient received first dose of bnt162b2 (Unspecified Shot), via unknown route of administration on 15Jan2021 at single dose for covid-19 immunisation (to make sure because I am a caregiver). Medical history included Sjoegren's syndrome and had like chronic fatigue but "that is not a real thing". Concomitant medications included buspirone hydrochloride (BUSPAR) and other medications that she just take a half every other day, it is a small amount. She take 5 mg every other day. She was really taking much. The consumer had lab work, may be not sure 2 to 3 weeks, she has been feeling lot of fatigue. Actually, she did do lab work, it was just like lot of blood work. The consumer stated, "I am having some loss of taste and tightening in the jaw and that was immediately. Tightening is still there and the taste loss seems to happen like a day later. Tightening is on the side where the forehead is and the front like on the two sides is the pressure on the side of the head. I guess, just thinking of a headache. I guess, I had headache and crying, it is just nerve-racking." The events started from 15Jan2021 with outcome of not recovered. Treatment received included Advil. Information on the batch number/lot number has been requested.
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| 63 | 2021-02-01 | muscle pain | Moderate muscle aches, fatigue, headache and nausea |
| 63 | 2021-02-03 | joint pain |
Aches and pains; Fatigue; Fever/My temperature was 99 which "generally" (not clarified) my temperatu...
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Aches and pains; Fatigue; Fever/My temperature was 99 which "generally" (not clarified) my temperature is usually 97; Arm was extremely painful; Joint pain; Headache; Could not work today because I was not feeling good; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot), via an unspecified route of administration, on 13Jan2021 (at the age of 63-years-old) as a single dose for COVID-19 vaccination. Medical history includes heart disorder. Concomitant medication included: Simvastatin, Atenolol, and medicine for my "heart". The patient reported that she received the first dose on 23Dec2021 and stated she had no reaction. On an unspecified date, the patient stated "I could not work today because I was not feeling good from the vaccine. I got it on the 13th I had off some work yesterday so I had a temperature aches and pains, fatigue and I had to call out last night. Today I am running still very slight fever, aches and pains - so it is improving." The first day, I was fine. I got it at the end of the day. The second day my arm was not red or anything but it was extremely painful, joint pain, headache, fatigue and my temperature was 99 (my temperature is usually 97). Today the temperature is lower and that does not hurt as much." The clinical outcome of the events malaise, aches and pain, fatigue, pyrexia, pain in arm, joint pain, and headache was unknown. No follow-up attempts are possible. No further information is expected.
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| 63 | 2021-02-03 | muscle pain |
muscle aches and discomfort; muscle aches and discomfort; pain was at the injection site; This is a ...
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muscle aches and discomfort; muscle aches and discomfort; pain was at the injection site; This is a spontaneous report via a Pfizer-sponsored program from a contactable nurse (reporting for herself). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), intramuscular in the left arm on 02Jan2021 at a single dose for COVID-19 immunization. Medical history was reported none. The patient's concomitant medications were not reported. The patient previously received the flu vaccine on unspecified date and experienced discomfort. On 02Jan2021, the patient experienced pain at injection site. On 03Jan2021, the patient experienced muscle aches and discomfort. The patient was scheduled for the second dose of the COVID-19 vaccine and reported that she took Aleve after she got the first vaccine and was wondering if she can take Aleve after the second one. She stated that it helped with the pain. She said that she was getting conflicting information and stated that she heard that there have been more symptoms associated with the second vaccine. She wanted to know if it was contraindicated for her to take the Aleve after getting the second dose. The patient described it as discomfort and stated that she gets it with the flu vaccine too. Aleve helped with the discomfort and the ache. She did not pre-medicate. She took it afterward. She stated that she took maybe 1-2 doses of the Aleve the next day and stated that by the end of the next day her pain was fine. The patient clarified pain was at the injection site and was achy. She said that she received the first vaccine on 02Jan2021 in the morning. She noticed the pain later in the day around midafternoon and said that it was gone by the next day. The outcome of the event pain at injection site was recovered on 03Jan2021 while outcome of muscle aches and discomfort was recovered on unspecified date in Jan2021.
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| 63 | 2021-02-04 | joint pain |
Soreness and swelling at site of injection 4 hrs after injection Chills one day after vaccine Jo...
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Soreness and swelling at site of injection 4 hrs after injection Chills one day after vaccine Joint pain one day after vaccine Fatigue one day after vaccine Foggy, light headed feeling one day after vaccine Headache and fatigue day 2 after vaccine
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| 63 | 2021-02-06 | muscle pain | Thick Tongue, itching face, head, arms legs, increased temperature, headache, muscle pain |
| 63 | 2021-02-07 | joint pain, muscle pain |
I had pain at the injection site initially and it increased on day 2. Also on day 2, I saw a small r...
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I had pain at the injection site initially and it increased on day 2. Also on day 2, I saw a small rash after showering. The muscle pain has de erased, but the injection site is very tender and the rash has spread down my arm about 2-3 inches. Today, day 5, the rash is slightly itchy. On day 2, I had chills, body aches, joint pain and a headache. All symptoms were gone within 48 hours with the exception of the headache. The headache lasted until day 5.
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| 63 | 2021-02-07 | neck pain |
Got covid 4 days after vaccine, severe cough, loss of taste, smell, aches, pain especially in my lef...
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Got covid 4 days after vaccine, severe cough, loss of taste, smell, aches, pain especially in my left side of neck. Went to E.R due to muscle spasms, taking motrin, tylenol. Still have severe neck pain.
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| 63 | 2021-02-09 | joint swelling |
Patient reports to me today that she developed increased swelling of feet and ankle the next morning...
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Patient reports to me today that she developed increased swelling of feet and ankle the next morning after receiving first vaccine dose. She does have a history of CHF and she did not seek treatment for condition at the time.
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| 63 | 2021-02-09 | musculoskeletal stiffness | Low grade fever, headache, muscle spasms, fatigue, aches and stiff muscles |
| 63 | 2021-02-09 | muscle pain, joint pain |
Muscle ache; Chills; Fever; was cold; Joint ache; Tired; Sick; could not sleep all night, she was up...
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Muscle ache; Chills; Fever; was cold; Joint ache; Tired; Sick; could not sleep all night, she was up half the night; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: F19262), via an unspecified route of administration at her arm on 23Jan2021 at 0.3 mg (as reported) single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that that she and her 94 year old mother got the COVID-19 vaccine at a drive thru, and her mother did great. After the vaccine she had muscle aches, chills, fever, and was cold. She had side effects that lasted 30 hours, starting that night. She was chilling so bad, she would like to know if they think it was safe for her to get the second dose of the vaccine, they said it was worse for the second. She said she could not hardly work she was so sick after the first dose. She stated that she was really cold, and really sick, and all day, she just could not sleep all night, she was up half the night because she was so cold and just feeling sick. She had joint pain, she had it all. She started taking Aleve on Sunday and she started to get better. The night after she got the vaccine she got her heater and was sitting beside it. She felt tired the whole next day. Her symptoms came quicker than that, she took the Aleve the next day. The outcome of events muscle aches, chills, fever, joint ache was recovered. The outcome of other events was unknown.
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| 63 | 2021-02-10 | spinal pain |
back of neck at the spine began feeling odd and maybe the middle of my spine; When I got the shot, I...
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back of neck at the spine began feeling odd and maybe the middle of my spine; When I got the shot, I felt something shoot into the arm and it felt a little startling or shocking to the body; feeling numb in my left pinky & a little in the ring finger plus a strange feeling (achy) in right arm/light numbness on outside of my left leg from the knee down to the ankle; feeling numb in my left pinky & a little in the ring finger plus a strange feeling (achy) in right arm/lighter soreness up the outside of my left forearm; The pinkies feel swollen when I bend them; soreness at the injection site; This is a spontaneous report from a contactable consumer (reported for herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9261; expiry date: not known), via an unspecified route of administration in the left arm on 26Jan2021 15:00 at single dose for COVID-19 immunization; and ibuprofen, via an unspecified route of administration from an unspecified date at 1 dosage form (DF) for an unspecified indication. Medical history included known allergies to some pesticides, herbicides, chlorox, or possibly the products mixed with them/permanent magic markers (mad her lips and face felt numb, could make it hard to breath, almost made her pass out once/made her feel sick in the past); and caused neuropathy up the back of her legs once. The patient is not pregnant. Concomitant medications included lactobacillus acidophilus (ACIDOPHILUS), melatonin, and ascorbic acid (SUPER C). The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 26Jan2021 20:00, after when she got the shot, she felt something shoot into the arm and it felt a little startling or shocking to the body. After 10 minutes, she did not feel it. The patient started feeling numb in her left pinky & a little in the ring finger plus a strange feeling (achy) in right arm. Eventually, she also felt a lighter soreness up the outside of her left forearm. The pinkies felt swollen when she bent them. She felt a normal soreness at the injection site. On 26Jan2021 23:50, she started feeling light numbness on outside of her left leg from the knee down to the ankle. The ankle on the outside felt a fairly pronounced numbness. Also, the back of neck at the spine began feeling odd and maybe the middle of her spine. Although she stated the spine spot had a twinge of pain the night before & in the morning so that might not be the vaccine. The right pinky also started feeling light numbness by 01:00 the next day. The patient took 2 Tylenol and before bed, she took 1 ibuprofen for back of neck at the spine began feeling odd and maybe the middle of her spine and soreness at the injection site. No treatment received for other events. The action taken in response to the events for ibuprofen was unknown. The outcome of the event "when I got the shot, I felt something shoot into the arm and it felt a little startling or shocking to the body" was recovered on 26Jan2021 20:10; while outcome was unknown for other events.
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| 63 | 2021-02-11 | joint pain |
Pfizer BioNTech COVID-19 Vaccine EUA left armpit lymph node swelling injection site pain headache na...
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Pfizer BioNTech COVID-19 Vaccine EUA left armpit lymph node swelling injection site pain headache nausea joint pain
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| 63 | 2021-02-14 | neck pain |
strange feeling and some pain began on left side of neck, left ear and went up my whole neck to my f...
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strange feeling and some pain began on left side of neck, left ear and went up my whole neck to my face. Unsure what the feeling was then realized it felt numb and swollen. tongue felt thick. kinda of like after being numb at dentist office. I also felt kind of tired. I was afraid my throat was going to close up but it didn't. after 1 hour the feeling began to fade. and then went away.
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| 63 | 2021-02-15 | joint pain | site pain, next day body aches, joint pain, headache, chills, no fever. tiredness. for two days |
| 63 | 2021-02-15 | musculoskeletal stiffness, joint pain | Chest pain and burning in the chest and lungs, body aches, diffuse joint pain, and body stiffness |
| 63 | 2021-02-15 | musculoskeletal stiffness |
My body was stiff and sore all over, for about 3 days ran fever 100.7 couldnt go to work 24 hours ,...
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My body was stiff and sore all over, for about 3 days ran fever 100.7 couldnt go to work 24 hours , and chest pains for 5 days and unable to lay on side while sleeping chest was enflamed, shortness of breath
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| 63 | 2021-02-16 | joint pain |
colitis flare up/soft stools and abdominal pains; my joints were aching: ankles, hips, elbows, shoul...
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colitis flare up/soft stools and abdominal pains; my joints were aching: ankles, hips, elbows, shoulders, wrist.; Also my allergies seemed to be bothering me more; This is a spontaneous report from a contactable other healthcare professional (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EJ1686), via an unspecified route of administration into the right arm on 11Jan2021 08:30 at a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, osteoporosis, ulcerative colitis, ongoing colitis and ongoing allergies to mites, mold, pollen, environmental and rubber. Patient was not pregnant. Concomitant medication included venlafaxine (VENLAFAXINE), zolpidem (ZOLPIDEM) and levothyroxine (LEVOTHYROXINE). The patient was previously administered with first dose of zoster vaccine recombinant, adjuvanted (SHINGRIX) via an unspecified route of administration into the right arm on 04Dec2020 for immunization. On 12Jan2021, the patient's allergies seemed to be bothering her more. On 13Jan2021 09:00, patient woke up with her joints aching: ankles, hips, elbows, shoulders and wrist. On 14Jan2021, patient experienced colitis flare up with soft stools and abdominal pains. The patient did not receive treatment for the events reported. Outcome of events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 63 | 2021-02-17 | back pain |
tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen fe...
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tongue was swollen and swore feeling in the back of mouth/tongue sensation continued with swollen feeling; tongue was swollen and sore feeling in the back of mouth/tongue sensation continued with swollen feeling; difficulty swallowing; sore throat sensation; no appetite; severe abdominal pains; diarrhea; mild heart palpitations; developed fever of 101 Fahrenheit; chills; back pain; Could not Sleep; This is a spontaneous report from a non-contactable consumer reported for herself. A 63-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3247, via an unspecified route of administration on 22Jan2021 09:00 at single dose in left arm for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was in hospital. Medical history included Hashimoto Disease; Moderate Metro Valve Prolapse; known allergies: food Intolerances (Gluten, Eggs, Diary, Soy, Corn). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ciclosporin (RESTASIS), calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D), ascorbic acid (VITAMIN C), ubidecarenone (COQ-10). The patient previously received the first dose of bnt162b2 with lot number: L0140 on 30Dec2020 10:30 AM in left arm for covid-19 immunisation, ciprofloxacin (CIPRO) and experienced drug allergy. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 (Friday Evening) post injection, she could not sleep. On 23Jan2021 (Saturday) severe abdominal pains post breakfast; breakfast was gluten free bread with vegan scrambled eggs and coffee w/ oat milk. Continued diarrhea for about 1 hour; mild heart palpitations, developed fever of 101 Fahrenheit; mild chills and back pain. On 24Jan2021 (Sunday) - still with fever 99.8; no appetite. On 25Jan2021 (Monday) - tongue was swollen and sore feeling in the back of mouth; difficulty swallowing; sore throat sensation; pain of swelling caused it hard anything; remained home from work, did not see medical doctor. From 25Jan2021 to 28Jan2021 tongue sensation continued with swollen feeling, each day getting slightly better by 28Jan2021 (Thursday) feeling normal. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered in Jan2021. The reporter considered the case as non-serious. No follow-up attempts are possible. No further information is expected.
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| 63 | 2021-02-17 | muscle pain |
This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the left arm on 02Feb2021 01:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included benazepril, atorvastatin calcium (LIPITOR), and ubidecarenone (COQ 10). On 02Feb2021 01:15, after 5 minutes getting the vaccine on her left arm, it started to get numb and her back and left leg. She had a headache and nausea. The nurse at the clinic took her to a room to rest and applied ice pack on her left arm. She stayed in the room for 2 hours. At night, her heart rate was rapid and she could not sleep. Next day, she had muscles sore and headache. Therapeutic measure was taken as a result of numbness in the left arm,. No treatment was received for the other events. Clinical outcome of the events was recovered with sequelae. Information on the lot/batch number has been requested.
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| 63 | 2021-02-18 | armpit pain |
First vaccine shot - No adverse events. Second vaccine shot - on the next evening (02/18/21), I had...
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First vaccine shot - No adverse events. Second vaccine shot - on the next evening (02/18/21), I had a very slight fever lasting just a couple of hours. Later in the evening, I had swelling and pain under my left arm pit lymph node. The pain continues as of this writing. The pain is dull in nature and more sensitive to the touch.
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| 63 | 2021-02-18 | back pain, neck pain, limb discomfort |
Within 1.5 hours of vaccine #1: Eye pain (both), itching without visible rash (left buttock only), ...
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Within 1.5 hours of vaccine #1: Eye pain (both), itching without visible rash (left buttock only), thumb pain, brief leg "heaviness" (both) and fatigue, brief RLQ pain, increased tinnitus. The next evening: low back and neck (bone?) pain while attempting to sleep, out of character to usual back pain. By day 3 post injection, left nose tingling similar to onset of cold sore, which included left side of mouth the next day. By 7 days post injection, entire mouth area felt tingly similar to Novocaine wearing off. This lasted 3 days. Now improved. (took B-12 p.o.) Other brief episodes of chest discomfort, gum irritation, and anxiety. Vaccine #2 scheduled for 2/19/2021
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| 63 | 2021-02-18 | musculoskeletal stiffness |
I seemed to have some itching on my scalp, and there was a little rash under my arms, along my stoma...
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I seemed to have some itching on my scalp, and there was a little rash under my arms, along my stomach area and a little on my face, the same as when I have been exposed to shellfish of some type, I took 2 benadryl that eve and was able to sleep, the itch went away, felt better on saturday by the afternoon started to feel itchy again took another benadryl and that helped. Had some puffiness in my hands and feet during the week, and stiffness not bad. Just wanted to let you know of the reaction.
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| 63 | 2021-02-21 | back pain |
Patient complained of tingling sensation of the mouth and tongue, no numbness, sensation remains int...
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Patient complained of tingling sensation of the mouth and tongue, no numbness, sensation remains intact., not in respiratory distress, able to respond verbally. Patient stated that she also experienced tingling on f the mouth and tongue and pain on lower back after her first dose, but resolved after 15 minutes.
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| 63 | 2021-02-22 | muscle pain |
2/9 NEXT DAY IN AM 99.7 FEVER; SORE ARM MUSCLE TO MOVE ARM. 2/10 DAY TWO 48 HRS 3-6:00PM TIGHT BU...
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2/9 NEXT DAY IN AM 99.7 FEVER; SORE ARM MUSCLE TO MOVE ARM. 2/10 DAY TWO 48 HRS 3-6:00PM TIGHT BURNING CENTER CHEST PAIN TOOK TYLENOL; WATER. 2/11 DAY 3 - TIGHT BURNING CHEST PAIN INTERMITTENT ALL DAY - TOOK TYLENOL; HYDRATED WITH WATER. 2/12 DAY 4 - NO DISCOMFORT; GOT COVID TEST TO RULE OUT - NEGATIVE. 2/13 DAY 5 TIGHT CHEST PAIN 1:00PM TOOK TYLENOL SUBSIDED ONE HOUR. 8:00PM BLOODY NOSE 30 MINUTES. OK THERE AFTER.
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| 63 | 2021-02-24 | joint pain, back pain |
I had a minimally sore injection sight the morning I had the vaccine. As the day went on I began to ...
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I had a minimally sore injection sight the morning I had the vaccine. As the day went on I began to feel joint pain in my back. Around 2:00pm I began to feel chills. Around 5:00pm I registered a temperature of 99.1. My usual temperature is 96.7. I then had trouble staying asleep, had intense joint pain in my back, hands, and feet, which I treated with Tylenol around 11:00pm. I experienced heavy night sweats where I woke up at 5:15 am being soaked. The symptoms I felt overnight felt just like what I had when I was sick with Covid 19 in December 2020. My temperature had returned to normal by 6:00 am.
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| 63 | 2021-02-24 | joint pain |
Sharp shooting pain down arm at time of injection. Subsided quickly and then 20 minutes later arm g...
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Sharp shooting pain down arm at time of injection. Subsided quickly and then 20 minutes later arm got sore, painful to lift or move around. Icy feeling and aching when arm is quiet. Painful to rotate shoulder. Some dizziness and lightheadedness.
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| 63 | 2021-02-25 | joint pain, back pain |
general aching joint pain, headache, spine pain not muscle pain felt like back was broken started ar...
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general aching joint pain, headache, spine pain not muscle pain felt like back was broken started around midnight lasted untill late evening. left thigh pain like someone was doing a vein stripping. nausea no vomiting. Felt bad for 2 days. reddness on left arm not at shot site with left arm pain for 2 days. reddness in lt arm still there 02-26-2021.Red raised area warm no drainage.
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| 63 | 2021-02-25 | back pain |
tingling and numbness on left side of mouth and face, beginning immediately after injection, and con...
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tingling and numbness on left side of mouth and face, beginning immediately after injection, and continuing intermittently for two days so far. Exacerbation of rash on right hand that usually occurs when exposed to wheat, beginning 24 hours after injection. Muscular pain in back beginning 12 hours after injection and subsiding 40 hours after injection.
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| 63 | 2021-02-25 | joint swelling | Small bump on left wrist, itching |
| 63 | 2021-02-26 | muscle pain | Cold chills, diarrhea, vomiting, shortness of breath, muscle soreness, light headed |
| 63 | 2021-02-28 | joint pain |
sore left arm/hip pain is radiating down to her leg; Knee pain; This is a spontaneous report from a ...
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sore left arm/hip pain is radiating down to her leg; Knee pain; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscular in left arm near shoulder on 25Jan2021 10:20 at a single dose for COVID-19 immunization/prevent covid. Medical history included ongoing arthritis diagnosed years ago, ongoing arthralgia, has two titanium knees and she had the hip pain prior to the COVID injection but now her hip pain is radiating down to her leg. Concomitant medications included celecoxib (CELEBREX) from an unknown date and ongoing at 100mg capsule once a day by mouth for arthritis. The patient previously received the first dose of BNT162B2 (Lot: EK9231) administered on 05Jan2021 around 13:00, intramuscular injection in left arm near shoulder for COVID-19 immunization, SHINGRIX two shot dose, she had one in Dec2018 and the second one in Mar2019, stated that it hurt to where she could not even lift the arm. It was reported that on 25Jan2021, patient had the second dose of the vaccine and she had the typical sore arm 6 hours later that lasted 24 hours. She clarifies it recovered completely 48 hours later and she does not have the soreness as of today, states it does not bother her. Reports she also has it to where her knees and hip are hurting her. She has two titanium knees and she had the hip pain prior to the covid injection, but now her hip pain is radiating down to her leg. She has arthritis and with weather changes she experiences the hip pain. Her daughter told her it is a side effect of the shot. She is asking why this hip pain is radiating down. The knee and hip pain started around 9pm on 25Jan2021. Reports it is a tad better but it is painful. She does not have a fever. Treatment for the events knee pain included putting ice and heat on her knee and hip. The outcome of sore left arm/hip pain is radiating down to her leg was recovered on 27Jan2021, knee pain was recovering.
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| 63 | 2021-02-28 | joint pain |
Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, E...
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Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Dose potentially administered too high but patient didnt bleed. Banaid placement described as one finger width below acrimion bone. Immediately \u2026 at the time of injection \u2026 shooting nerve pain radiating down the arm into fingers. Pain became a hot tingle over the next 15-30 minutes. Impaired right arm mobility and range of motion \u2026 shoulder pain with motion beyond a modest range. Three days later still experiencing some pain with certain arm motions \u2026 primarily raising arm above shoulder
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| 63 | 2021-02-28 | back pain |
preseptal cellulitis eyelid; hurt her back, aggravating the back pain; hurt her back, aggravating th...
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preseptal cellulitis eyelid; hurt her back, aggravating the back pain; hurt her back, aggravating the back pain; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9261), via an unspecified route of administration in the right arm on 20Jan2021 at 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included breast cancer from 2015, back pain (which predated vaccination with BNT162B2), cholesterol, diabetes, blood pressure, kidney stones, vitamin D low, allergy, depression, lichen sclerosus and hair loss. Ongoing concomitant medications included simvastatin for cholesterol, empagliflozin (JARDIANCE) for diabetes, metformin for diabetes from 20Dec2020, linagliptin (TRADJENTA) for diabetes, hydrochlorothiazide/valsartan for blood pressure, potassium citrate (UROCIT-K) for kidney stones, vitamin D for vitamin D low, fexofenadine hydrochloride (ALLEGRA) for allergy, anastrozole (ARIMIDEX) for depression, clobetasol propionate for lichen sclerosus, lidocaine hydrochloride (ASPERCREME WITH LIDOCAINE) for back pain, minoxidil for hair loss. There were no additional vaccines administered on the same date as BNT162B2, and no vaccinations within 4 weeks prior of BNT162B2. On 06Feb2021, the patient hurt her back, aggravating the back pain. On 06Feb2021, the patient experienced preseptal cellulitis of the eye lid. The events required a visit to the emergency room and physician office but did not require admission to the hospital. The patient went to the doctor on 06Feb2021 for preseptal cellulitis of the eyelid and was treated with cephalexin 250 mg orally four times a day from 06Feb2021 to 11Feb2021, and dexamethasone/neomycin/ polymyxin b (NEOPOLYDEX) from 06Feb2021 and ongoing three times per day. On 08Feb2021, the patient took paracetamol (TYLENOL) 500 mg for the back pain. The patient went to the doctor for the back pain on 11Feb2021 and was prescribed meloxicam 15 mg once daily and cyclobenzaprine 10 mg, (take one half by mouth as needed). Reportedly, the cyclobenzaprine did absolutely nothing. The patient also took paracetamol (TYLENOL ARTHRITIS) 650 mg per her doctor's recommendation. The clinical outcome of preseptal cellulitis eyelid was resolving, and of "hurt her back, aggravating the back pain" was not resolved.
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| 63 | 2021-03-01 | joint pain, muscle pain |
This is the 2nd time since my 2nd shot my throat neck glands are big and sore & thyroid is swelled u...
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This is the 2nd time since my 2nd shot my throat neck glands are big and sore & thyroid is swelled up & sore difficult to swallow. Extreme long lasting exhaustion. Body is weak & sore muscles & joints. I have not been ok since my 2nd shot. I had a hard marble lymph node in my neck after the 2nd shot too.
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| 63 | 2021-03-02 | joint pain, back pain, muscle pain |
COVID shots Shot Feb 1, 2021 Day one of shot fatigue Day two of shot thigh cramps Day three of shot ...
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COVID shots Shot Feb 1, 2021 Day one of shot fatigue Day two of shot thigh cramps Day three of shot nausea Day four of shot back and joint pain Day five of shot sick feeling aching all over. Muscle and joint pain and fatigue. Chest pressure, cough, Hoarse voice Day six of shot headache fatigue pain through right eye. 2/5Temp 96.6, 98.6, 1:00pm SPO% 93% Resting heart rate 90 6:30pm SPO% 89%-91% Resting heart rate 102 Tylenol 100 mg 9:00am, 3:30pm TEMP 4:30pm 99.7* Symptoms of the freezing chest and cough as well as headache and feeling poorly kept rising several times a week. Covid 3/1/21 Covid symptoms return just like after Covid 19 1st vaccine. Body aches, joint pain, Chest pain, muscle aches, frozen feeling in lungs, cough, abdominal pain,eye ache, headache and fever. Temp 95.5 SPO 89% - 94% Resting heart rate 92 - 95 (After Covid shot 89%SPO, RHR 105, temp 99.7) 12:25pm temp 99 2/2/21 Feeling a little better. Still fatigue and ill feelings. At nighttime cough comes back with freezing lung feeling. Also started and body aches and joint stiffness. Went to bed took ibuprofen. 2/3/21 Still feeling ill . Woke with productive cough a little looser. Headache fatigue just feeling crummy.
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| 63 | 2021-03-02 | weight decreased, muscle tightness, back pain |
Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at...
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Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at injection site. She reports feeling like a foreign body in injection site and reports feelings of tightness, pressure, and heat at site. Patient developed swelling of right arm over the next 3 weeks. Patient saw her PCP on 2/12/21 and an ultrasound was done to R arm. Results were negative. Five to six weeks post vaccine administration, patient is reporting weight loss over 10 pounds, possible hair loss, loose stools, and sweaty palms and feet. She also reports the right arm pressure and tightness is now radiating to her upper back.
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| 63 | 2021-03-03 | joint pain, joint pain, musculoskeletal stiffness |
Patient received Pfizer dose#2 on 1/2/2021. Then approximately 3 weeks post vaccine, she began to ex...
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Patient received Pfizer dose#2 on 1/2/2021. Then approximately 3 weeks post vaccine, she began to experience acute upper arm/ clavicular joint pain and bilateral hands were "cupped". Received steroid treatment from PMD.
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| 63 | 2021-03-03 | back pain | Chest pain radiating to back with associated nausea, transient hypertension |
| 63 | 2021-03-03 | muscle pain, joint pain |
Fever; joint & muscle pain; joint & muscle pain; Injection site - large red spot (about 4 inches in ...
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Fever; joint & muscle pain; joint & muscle pain; Injection site - large red spot (about 4 inches in diameter); swollen; hot to touch; other vaccine same date dose number 6; This is a spontaneous report from a contactable healthcare professional (patient). This 63-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; EL3247) via an unspecified route of administration in the left arm on 29Jan2021 at 14:15 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included allergy to shellfish and allergy to eggs, both from unknown dates and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EL0142) in the left arm on 11Jan2021; codeine from an unknown date for an unknown indication and experienced allergy; celecoxib (CELEBREX) from an unknown date for an unknown indication and experienced allergy; and alendronate sodium (FOSAMAX) from an unknown date for an unknown indication and experienced allergy. The patient reported fever, joint and muscle pain 24 hours after the vaccine and stated it lasted about 18 hours. She also reported about the injection site that it was a large red spot (about 4 inches in diameter), it was swollen and hot to touch starting about 24 hours after vaccination. She reported 3 days later it was still red, swollen and hot to touch. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of fever, joint and muscle pain were recovered on 31Jan2021. The clinical outcomes of large red spot (about 4 inches in diameter), swollen, hot to touch were not recovered. The clinical outcome of other vaccine same date dose number 6 was unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19.
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| 63 | 2021-03-03 | muscle pain | Tiredness, headache, muscle pain, chills, fever |
| 63 | 2021-03-04 | facial discomfort |
Approximately one hour after the shot, my face began feeling strange. My nose was red and warm as w...
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Approximately one hour after the shot, my face began feeling strange. My nose was red and warm as well as my cheeks. Then my lower lip began to swell. I would consider these symptoms somewhere between mild to moderate. The symptoms began around 4:30 in the afternoon and subsided as the evening progressed. The next morning (today), my face feels basically normal again. My only symptoms now are a sore arm and a slight headache. I have experienced allergic reactions before but never from a vaccine.
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| 63 | 2021-03-07 | joint pain, back pain |
I started to notice mid February 2021 that I was having joint tenderness in both hips and knees wit...
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I started to notice mid February 2021 that I was having joint tenderness in both hips and knees with some lower back aches. This is not preventing me from work or activities of daily living but significant enough to report especially the bilateral hip (joint) tenderness which I have never had. I walk 2.5 miles 3 times a week (my routine) and for the first time am noting the discomfort.
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| 63 | 2021-03-07 | back pain |
Symptoms. Extreme leg and leg pain. Unable to stand for any length of time. Unable to feel my feet...
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Symptoms. Extreme leg and leg pain. Unable to stand for any length of time. Unable to feel my feet. My left knee froze up . Weak wobbly legs. Bleeding gums. Back pain radiating up to my neck. My Neuropathy was pretty much in control until I took the vaccine. I am back in a wheelchair .
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| 63 | 2021-03-07 | joint swelling, muscle pain, joint pain |
Swelling in ankles/feet/calves/upper thighs, shortness of breath, fatigue. muscle soreness all over,...
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Swelling in ankles/feet/calves/upper thighs, shortness of breath, fatigue. muscle soreness all over, joint pain (esp. wrists & knees). Was hospitalized for 3 days 3/20 - 3/23/2021.
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| 63 | 2021-03-07 | joint swelling, muscle pain |
classic migraine-type headache 03/05-present overall muscle ache 03/05-present fatigue 03/05-prese...
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classic migraine-type headache 03/05-present overall muscle ache 03/05-present fatigue 03/05-present nausea 03/05-present L foot & ankle swelling 03/06-present
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| 63 | 2021-03-07 | muscle pain |
Arm aching took acetaminophen. Extremely tired, short of breath, headache, low fever, achy muscles ...
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Arm aching took acetaminophen. Extremely tired, short of breath, headache, low fever, achy muscles all lasting to 30 hours after vaccine. Itchy Rash on arm and hard sport for 4 days.
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| 63 | 2021-03-07 | muscle pain |
Tiredness, headache,muscle pain,chills,fever all cleared up in 24 hrs; minor dizziness on 3rd day cl...
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Tiredness, headache,muscle pain,chills,fever all cleared up in 24 hrs; minor dizziness on 3rd day cleared up after several hours.
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| 63 | 2021-03-08 | joint pain |
24 hrs after getting injection, stated running fever of 99. Chills, body aches and pains in the joi...
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24 hrs after getting injection, stated running fever of 99. Chills, body aches and pains in the joints
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| 63 | 2021-03-08 | muscle pain |
Ringing in ears that I still have a week later. (I know of two friends in other parts of the countr...
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Ringing in ears that I still have a week later. (I know of two friends in other parts of the country that are also suffering with this.) Also, around 12 hours after shot I had four hours of extreme muscle pain and shivering. This was on my first dose. I know it's prevalent on the 2nd dose. I'm not worried about that but am concerned with my hearing.
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| 63 | 2021-03-08 | muscle pain |
About two hours after my injection, the muscles in my upper left arm were very sore. It felt like a ...
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About two hours after my injection, the muscles in my upper left arm were very sore. It felt like a bruise, tender to the touch.
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| 63 | 2021-03-09 | joint pain |
Onset of chills, body aches, joint pain, headache, diareah During night face turned bright red and b...
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Onset of chills, body aches, joint pain, headache, diareah During night face turned bright red and body felt hot General tired and achy lasting 4 days
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| 63 | 2021-03-09 | musculoskeletal pain | Bad Stomach ache, chills, pain in lower left buttocks, fatigue |
| 63 | 2021-03-10 | joint pain |
HA and muscle pain at injection site within 1 hour, joint pain at shoulders/hips/ feet starting at...
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HA and muscle pain at injection site within 1 hour, joint pain at shoulders/hips/ feet starting at 14 hours post dose and lasting for 36 hours. all treated with tylenol and NSAID. Moderate fatigue requiring rest for 24 hours. palpitations for 30 minutes at 14 hours post dose - no treatment, self-resolved
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| 63 | 2021-03-10 | joint pain |
Had Bamlanivimab IV on December 9, 2020 at The County Hospital. On 3/9/2021 had first Covid injecti...
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Had Bamlanivimab IV on December 9, 2020 at The County Hospital. On 3/9/2021 had first Covid injection. I had slight headache, sore throat, gland in neck swollen, chills and bad hip pain that started about11:00 am on 3/10/202. Today, feeling some better but very tired.
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| 63 | 2021-03-10 | facial discomfort |
pt stated that she got really warm within a couple of minutes of getting the vax. Pt got tightness...
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pt stated that she got really warm within a couple of minutes of getting the vax. Pt got tightness under eyes, checks, and inside her mouth. She had some pinching feelings in her chest which she said this may be acid reflux. Her right leg was hurting near her ankle and foot. Nurse at vax site checked her stats and everything was normal. She was given Benadryl. These symptoms subsided. After getting home she had some tickling in her throat. Pt only has soreness and redness in her left arm today.
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| 63 | 2021-03-10 | joint swelling |
10 hours after first dose of Pfizer Vaccination, I developed an itchy, raised bump that looked like ...
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10 hours after first dose of Pfizer Vaccination, I developed an itchy, raised bump that looked like a mosquito bite on the inside of my left elbow (same arm as vaccination). It resolved over the following couple of hours. 24 hours after vaccination (14 hours after the original presentation of the itchy bump on my elbow), I developed a couple of itchy bumps on my leg and trunk. Over the following 16 hours (24-40 hours after vaccination) I had what was diagnosed by health care professionals as an outbreak of hives affecting both forearms, both ankles, left knee and trunk. This episode resolved about 40 hours after vaccination. One week later, I have had mild, generalized, off and on itching and prickly skin sensation but no obvious outward signs of bumps or rash. I am seeking advice from an allergist on whether to proceed with second vaccination. Will be tested for PEG reaction before then. This is my second report. I requested a key to update my initial report (VAERS E-Report) but never received one.
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| 63 | 2021-03-11 | muscle pain, joint pain |
ADVERSE EVENTS: INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, JOINT PAIN, FEVER (1...
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ADVERSE EVENTS: INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, JOINT PAIN, FEVER (101.9 DEGREE F @ 2 AM 3/11/21 & BETWEEN 100.6 - 99.6 THROUGH THE EVENING 3/11/21), NAUSEA, FEELING UNWELL, SWOLLEN LYMPH NODE. TREATMENT: TYLENOL EVERY 4 HOURS STARTING AT 8 AM 3/11/21. SYMPTOMS SUBSIDED THROUGH THE LATE NIGHT OF 3/11/21 EXCEPT SWOLLEN LYMPH NODE & INJECTION SITE PAIN STILL PERSISTS 3/12/21.
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| 63 | 2021-03-11 | neck pain, back pain |
Immediate pain from injected arm, across back up the neck, causing headache and going across to ot...
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Immediate pain from injected arm, across back up the neck, causing headache and going across to other arm, down arm and making left hand tingle. Sensitivity to use of finger on left hand. That went away next day. Residual effects pain in my jaw and teeth sensitivity, continues to date. Hot flashes, shooting pains in foot, arm, hand, eye, leg randomly. raised blood pressure.
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| 63 | 2021-03-12 | joint pain |
Sore left arm, sleeplessness 10:30 pm to 5:00 am 3/12-3/13. Took 2 Somnapure natural sleep pills at ...
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Sore left arm, sleeplessness 10:30 pm to 5:00 am 3/12-3/13. Took 2 Somnapure natural sleep pills at 11 pm 3/12 and Soothsayer herbal tea at 7 am 3/13. Very tired both shoulders hurt noon 3/13. Took an hour and a half nap from 1-2:30 pm 3/13. Still tired
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| 63 | 2021-03-12 | joint pain |
Instant headache, fast heartbeat, instant face and headache flush, instant joint pain and very sever...
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Instant headache, fast heartbeat, instant face and headache flush, instant joint pain and very severe dizziness and lightheaded.
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| 63 | 2021-03-13 | joint pain |
Minor soreness in arm 24 hours after injection. Sharp pain in right hip 72 hours after injection, fo...
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Minor soreness in arm 24 hours after injection. Sharp pain in right hip 72 hours after injection, followed by break out of shingles rash the following morning. Diagnosed at visit to doctor 3/2 and treated with Valtrex and Gabapentin. As of 3/14 rash is fading and pain is mostly gone.
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| 63 | 2021-03-13 | muscle pain | Headache, Fever, Chills, Muscle Aches, Nausea |
| 63 | 2021-03-13 | muscle pain | Tiredness, muscle aches, stomachache. Rash on Neck |
| 63 | 2021-03-13 | neck pain |
Within an hour after receiving the vaccine which stung going in, I started to experience severe and ...
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Within an hour after receiving the vaccine which stung going in, I started to experience severe and debilitating pain in my neck. It starts at the base of my skull and ends at the top of my back. This pain is incredibly severe and is not resolved with anything. I tried Tylenol, Advil, Aleve, CBD oil, meditation, hot shower, whiskey, heat, and ice. NOTHING works. It is now Sunday and the symptoms are still present. They are not as often, but still as severe when they occur. I am very hesitant to get the 2nd shot now because of this reaction. I typically have a high tolerance for pain, but if this was constant I would not be able to live with it. Talking and breathing were unbearable!
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| 63 | 2021-03-14 | joint pain, muscle pain |
Headache; Swollen lymph nodes on her neck; Dizziness; Her feet felt swollen and she hurt when she wo...
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Headache; Swollen lymph nodes on her neck; Dizziness; Her feet felt swollen and she hurt when she would step down; Loss of appetite; She slept all day; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; Injection site pain; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9264B), intramuscular on 01Feb2021 at single dose for COVID-19 vaccination. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249) on 11Jan2021 for COVID-19 vaccination. Caller was a consumer that was calling about the Covid-19 vaccine and said that she wanted to report her symptoms after the Covid-19 vaccine. Caller reported that she experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain on, fever, feeling unwell, her feet felt swollen and she hurt when she would step down, loss of appetite and she slept all day on 01Feb2021, swollen lymph nodes on her neck and dizziness on 02Feb2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The seriousness was reported as non-serious. The outcome of the events injection site pain, chills, fever, swollen lymph nodes on her neck, dizziness, her feet felt swollen and she hurt when she would step down, loss of appetite and she slept all day were recovered and other events were recovering.
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| 63 | 2021-03-14 | joint swelling |
Patient called the pharmacy on 03/15/2021 to report adverse effects experienced post-vaccination. Pa...
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Patient called the pharmacy on 03/15/2021 to report adverse effects experienced post-vaccination. Patient reported feeling a burning sensation in front of / underneath knee cap area of right leg with symptom onset of about 3-5 days post-vaccination. Patient noted that symptoms escalated to severe swelling of both knees about a week post-vaccination.
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| 63 | 2021-03-14 | musculoskeletal stiffness |
Vaccine triggered migraine. Relief from sumatriptan and motrin. Continued to come back for 2 more da...
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Vaccine triggered migraine. Relief from sumatriptan and motrin. Continued to come back for 2 more days but was relieved by motrin. Also stiffness in shoulder and neck on opposite side of body that was damaged years ago in car accident causing whiplash. That is still ongoing 11 days later, but seems to be resolving slowly.
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| 63 | 2021-03-14 | neck pain, muscular weakness, back pain, muscle pain |
Both upper arms and upper back have extreme burning pain and tightness. All of my muscles ache. Bo...
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Both upper arms and upper back have extreme burning pain and tightness. All of my muscles ache. Both calves felt weak. Extreme fatigue. Increased ear ringing. Sinus and head pressure. Slight queasiness. When the shot was first given, I had immediate pain at the injection site and up my neck. As the day progressed I felt tired, achy all over. The burning, stinging pain increased, in both arms and upper back. It seems worse at night and wakes me up. It is severe enough that it makes me cry. I have used regular strength Tylenol, Regular strength Advil and Allegra, as treatment. The burning pain continues. So does the muscle aching and fatigue.
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| 63 | 2021-03-15 | joint pain |
Tiredness Headaches Chills Joint pain Nausea Feeling unwell Took Motrin Ate light Slept Kept moving ...
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Tiredness Headaches Chills Joint pain Nausea Feeling unwell Took Motrin Ate light Slept Kept moving All side effects ceased after 24 hours except tiredness.
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| 63 | 2021-03-15 | back pain, spinal pain |
Second Pfizer: I had a mild headache and sore R arm the evening of the 24th. The next day, I became ...
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Second Pfizer: I had a mild headache and sore R arm the evening of the 24th. The next day, I became very ill around 1pm with incontrollable chills, severe spinal pain from Cervical to sacrum, and severe radiating pain on both sides of my back. Pain ranked as a 7-8/10. Took 800 mg of Advil and then took Tylenol 3 hours later and no change. Thought about going to ER but did not go. The next day pain was reduced to a 3/10 and was extremely tired and no energy and was lying down most of the day with extremely fatigue. Gradually better the next two days for full recovery.
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| 63 | 2021-03-15 | back pain | Severe back ache which lasted for 3 days |
| 63 | 2021-03-16 | musculoskeletal stiffness |
Received the vaccine on Saturday on Sunday night started getting a headache and woke Monday morning ...
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Received the vaccine on Saturday on Sunday night started getting a headache and woke Monday morning with a headache, a stiff neck and swelling on my left side of my neck, trapezoid and my dowager hump. After 2 weeks most of the swelling is gone just a slight bit. Headaches have been every day until yesterday. Went to dr the following Monday after the vaccine as was give some anti inflammatory shots in my neck as not allowed anything ( cortisone) due to vaccine. Taking Tylenol and Advil and using Valteran. Dr was not sure if from exercise or the vaccine but have been exercising throughout the pandemic. Never had headaches when my neck would bother me only hand tingling and that was not this time. The acupuncturist today said still a bit swollen and tender and feels that it is a combination of the neck and the vaccine as the vaccine attacked my most vulnerable spot. I had a massage today to to try to stretch my neck. Headache is doing better today and I can move my neck more.
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| 63 | 2021-03-17 | joint pain, muscle pain |
Started with joint and muscle aches at 5:30 on 3/17, by 9:30pm, very painful to take a deep breath, ...
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Started with joint and muscle aches at 5:30 on 3/17, by 9:30pm, very painful to take a deep breath, chills, fever of 100.2, injection site left arm throbbing, tired and weak, slight headache and nausea. Tired and weak, achy and slight headache when woke up on 3/18. Still somewhat painful to take a deep breath and injection arm painful. Tylenol 2 tablets at 8:30 am and 2:30pm on 3/18
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| 63 | 2021-03-17 | joint pain |
I had a migraine the day after the vaccine, then on Wednesday, I had knee pain. I took steroids that...
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I had a migraine the day after the vaccine, then on Wednesday, I had knee pain. I took steroids that night but I couldn't hardly slee because of the pain. I had to call out because I could hardly walk. Steroid dose was for 9 days and after wards it resolved.
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| 63 | 2021-03-17 | musculoskeletal stiffness |
stiff neck along and above injection site--started next morning after injection and has continued fo...
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stiff neck along and above injection site--started next morning after injection and has continued for 5 days with soreness/stiffness abating somewhat after day 3
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| 63 | 2021-03-18 | joint pain |
Chills; stomach pain joints; vomit; weak blood pressure; stomach pain joints; This is a spontaneous ...
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Chills; stomach pain joints; vomit; weak blood pressure; stomach pain joints; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm at 63-year-old (not pregnant at the time of vaccination) on 03Mar2021 at 16:00 (lot number: EN6198, expiration date unknown) at single dose for COVID-19 immunization. Medical history included diverticulitis. No known allergies were reported. The patient was not diagnosed with COVID prior vaccination. Concomitant medications were reported as unspecified other medications in two weeks. No other vaccine in four weeks. On 04Mar2021 at 06:00 AM the patient experienced chills stomach pain joints vomit weak blood pressure (as reported). The events resulted in hospitalization. The patient underwent lab tests and procedures which included nasal swab: negative on 04Mar2021. No COVID tested post vaccination. It was unknown whether treatment was received. The outcome of the events was not recovered.
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| 63 | 2021-03-18 | joint pain |
joint pain, chills, nausea, dizziness, HA, chest is heavy, diarrhea X1 episode, spoke to doctor who ...
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joint pain, chills, nausea, dizziness, HA, chest is heavy, diarrhea X1 episode, spoke to doctor who stated the symptoms are "normal", clarified if she mentioned the dizziness & heaviness to chest, reported she did and her pcp stated it was again "normal". informed her those reported symptoms should be checked in the ED for potential cardiac events. Caller verbalized understanding.
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| 63 | 2021-03-18 | joint pain | Persistent joint pain, headache, fatigue for over 1 week |
| 63 | 2021-03-19 | muscle pain |
I started coughing for about an hour around 10pm while I was on a phone call; then developed a fuzz...
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I started coughing for about an hour around 10pm while I was on a phone call; then developed a fuzziness in my throat and felt like I had mucus in my chest. I took 120 mg Allegra. I started to feel relief after about 10 minutes. I had to relieve my throat of mucus this morning. Other than muscular aches, especially at the site of the vaccine and behind my shoulder, I am ok. About 10 - 11 hours after my first vaccine on 2/26/2021, I developed a similar reaction, however much milder, and took Allegra, which relieved the symptoms.
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| 63 | 2021-03-20 | armpit pain |
developed a pain under my arm near armpit area on the side of the injection; swollen gland; Dose Num...
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developed a pain under my arm near armpit area on the side of the injection; swollen gland; Dose Number 1 31Dec2020/Dose number 2 17Jan2021; Dose Number 1 31Dec2020/Dose number 2 17Jan2021; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL8982; expiration date: unknown) at vaccination age of 63-year-old via an unspecified route of administration in the right arm on 17Jan2021 09:15 as a single dose for covid-19 immunization. Medical history included GERD (gastrooesophageal reflux disease), asthma, IBS (inflammatory bowel disease), diverticulosis, osteoarthritis, lactose intolerant, penicillin allergy and hives. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included famotidine and montelukast. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: E1284) at vaccination age of 63-year-old via an unspecified route of administration in the right arm on 31Dec2020 at 15:15 as a single dose for covid-19 immunization. The patient previously took codeine but had hallucination, pantoprazole sodium but joint pain, and diclofenac sodium but had anemia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. The patient first dose was on 31Dec2020 while the second dose was on 17Jan2021. It was reported that on 19Jan2021 (About 36 hours after injection), the patient developed a pain under her arm near armpit area on the side of the injection. It appeared to be a swollen gland. It lasted about 2 days and was moderate pain that she treated with 600 mg Ibuprofen. Soreness remained for another day or two after the pain subsided. The events were considered non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events swollen glands and axillary pain were recovered in an unspecified date in 2021 while the outcome of the other events was unknown.
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| 63 | 2021-03-21 | musculoskeletal stiffness |
Started with a bad headache and very sore arm the first night. The morning of the day after I was va...
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Started with a bad headache and very sore arm the first night. The morning of the day after I was vaccinated, I took my temperature and it was up to 101, which is high for me. I ached everywhere and my neck was so stiff, I could hardly stand to turn my head. My left arm, where I was vaccinated felt sore and tight in my shirt, but I couldn?t turn my head far enough to look at it to see if it was red or not. My temp went up to 102, the highest it?s been since I had osteomyelitis after my accident- no kidding! I slept most of the day both Thursday and Friday. I woke up Saturday at 2 pm and felt fine again- like nothing happened. But, I thought it was Friday. I was sick enough & sleeping enough that I acted lost a day completely! I never got nauseous- just terrible headache, stiff neck, joint & muscle pain , fatigue and 102 fever. There is a question of whether I have had Covid. I was very sick for 4 weeks- the whole month of February, 2020. My daughter had been in (Country) on business and met with collegues from all over the (Country), including (Country), in January, 2020. My brother died unexpectedly while she was gone. She flew back to (State) on a Thursday night and then got right back on a flight to (city) to stay with me for a week. She missed the wake, but was a comfort to me. I get very sick about a week after she left.
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| 63 | 2021-03-22 | joint pain |
After the 1st shot, I was ill for about a day: extreme fatigue, every joint in body ached, sore thro...
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After the 1st shot, I was ill for about a day: extreme fatigue, every joint in body ached, sore throat. After 2nd shot, not symptoms until Saturday. I noticed a swelling between my left breast and my armpit. It developed into a very pronounced lump at my armpit and toward left breast. There was tenderness when I used the arm. As of today, the swelling is down- not quite normal yet- but no tenderness.
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| 63 | 2021-03-22 | back pain, neck pain |
Pain at injection site (84.1%) no ? Fatigue (62.9%) yes ? Headache (55.1%) yes ? Muscle pain (38.3%)...
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Pain at injection site (84.1%) no ? Fatigue (62.9%) yes ? Headache (55.1%) yes ? Muscle pain (38.3%) some lower back ? Chills (31.9%) no ? Joint pain (23.6%) neck ? Fever (14.2%) no ? Injection site swelling (10.5%) no ? Injection site redness (9.5%) no ? Nausea (1.1%) no ? Malaise (0.5%) yes ? Lymphadenopathy (0.3%) no Blood pressure high on 4th day with accompanying eye pressure. 155/102
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| 63 | 2021-03-23 | joint pain, muscle pain |
Saturday morning I woke up feeling fine. About an hour later I had a bad headache and my body starte...
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Saturday morning I woke up feeling fine. About an hour later I had a bad headache and my body started to be achy. That was followed by bilateral eye pain so that the only comfortable thing to do was to put on eye shades. I was exhausted by the afternoon. I had absolutely zero energy to do anything but lie down. By Sunday morning every inch of my skin was sensitive, every joint was sore and every muscle group in my body was painful. The symptoms from the previous day remained; head and eye pain. I used both tylenol and advil a few times but without relief. Monday my body/joints were still achy and I was super tired but not like the previous 2 days. I became very depressed and fearful that it would not let up. Today is Wednesday and its the first day I feel like myself again although I did have to take a nap 3 hours after I woke up today. Body still aches but nothing like it was
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| 63 | 2021-03-23 | joint pain |
Feverish, sweating, mid- level headache, and at 8 pm muscle pain especially in breasts, jaws and ev...
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Feverish, sweating, mid- level headache, and at 8 pm muscle pain especially in breasts, jaws and every joint that has arthritis was very painful. Couldn?t sleep until 3 a.m... Woke up at 5 a.m. and all symptoms were gone. None since.
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| 63 | 2021-03-23 | joint pain |
Injection of shot was extremely painful with heavy stinging and burning sensation. Approximately 4 ...
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Injection of shot was extremely painful with heavy stinging and burning sensation. Approximately 4 hours after receiving shot on Friday, extreme fatigue, arm ache, full body/joint ache and severe headache. Took Tylenol and slept. Symptoms lasted until Sunday morning, although low grade headache persisted until Monday morning.
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| 63 | 2021-03-23 | armpit pain |
1002 63 y.o W/F c/o Left axillary pain radiating to left chest wall, rated 4/10. Onset 15 minutes s\...
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1002 63 y.o W/F c/o Left axillary pain radiating to left chest wall, rated 4/10. Onset 15 minutes s\p vaccination to left arm. Denies SOB, difficulty breathing or any other symptoms. HX of Hypothyroidism, and Hypoglycemia currently on Synthroid and OTC vitamins. Denies any other pertinent history. Allergies to Wheat and Gluten only. VSS 97.4-131/79-70-18-99% on RA. Pt placed in supine position, notified Drand at bedside evaluating patient. EMS arrived (see diagnostics below) for evaluation as well. 1044--- Pt transferred to ED via stretcher for further evaluation in no acute distress.
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| 63 | 2021-03-23 | groin pain, back pain, muscular weakness |
3-11-21 pain in groin on right side/leg weakness around 2:00pm better next day just sore arm., Fatig...
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3-11-21 pain in groin on right side/leg weakness around 2:00pm better next day just sore arm., Fatigue on 3-12 & 3-13. On 3-14 developed intense pain right side lower back and kidney. 3-16 went to Doctor as felt I had kidney infection but urine checked find, she thought it was muscle spasms. 3-19 broke out with shingles and back to doctor on 3-22 and given Acyclovir and Gabapentin. 3-23 went to ER. In as woke with pain so severe I broke out in sweat and threw up. Gave me Hydrocodone, nurse commented was worse break out she had ever seen. Internal pain is worse than the rash which is naval to spine and 3 to 4 " wide.
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| 63 | 2021-03-24 | joint swelling |
cankers under her tongue; above her left kneecap it looked like a mushroom hard in the middle water ...
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cankers under her tongue; above her left kneecap it looked like a mushroom hard in the middle water around it; On right leg there was a big red welt the size of her calf.; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A 63-year-old female patient received bnt162b2 (BNT162B2) (at 63 years of age), dose 1 via an unspecified route of administration on 08Mar2021 14:20 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history included allergic reaction now and then to sulphur based medicines. The patient's concomitant medications were not reported. The patient received 1st shot 0220 pm yesterday (08Mar2021), she came home and she was fine, she worked around the house, she took a shower and above her left knee cap it looks like there was another knee cap and it looks like in the shape of a mushroom it was hard in the middle, water around it. On her right leg there was a big red welt that was the size of her cap, she had canker under her tongue. She went to the hospital and the hospital gave her an Epipen. She was curious if she should receive her second shot. Therapeutic measures were taken as a result of the events with Epipen which was given to her as a precaution. The patient was hospitalized due to the events. The outcome of the events was unknown. Information on the batch/lot number has been requested.
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| 63 | 2021-03-24 | limb discomfort, joint pain |
Next day, March 24: 6:00 am: headache, achy joints, fatigued, feeling "punk" or heavy limbs. 10:00 ...
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Next day, March 24: 6:00 am: headache, achy joints, fatigued, feeling "punk" or heavy limbs. 10:00 am: severe headache, aches and fatigue much worse, in bed and sleeping. 3:00 pm: Added chills. 7:00 pm: Added mild fever (100). Thursday, March 25. Woke up with very mild symptoms, but still fatigued and without energy. 3:00 pm back to normal.
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| 63 | 2021-03-24 | muscle tightness |
Tightening in left pectoral muscle in the left arm pit which spread across my chest to the right pec...
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Tightening in left pectoral muscle in the left arm pit which spread across my chest to the right pectoral within 15 minutes the tightness moved up into my neck. Within one hour it was gone. It was tightness not pain. Doctor at vaccine site recommended transporting me to the ER. Tests were administered, I was released with follow up recommendations. Next day some intermittent chest tightness-agreeing of pressure from both sides and weight on breast bone. One time tightness in left chest during short walk.
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| 63 | 2021-03-24 | muscle pain, joint pain |
2 days following 1st Pfizer vaccine developed burning and stiffness, and pain in joints, followed by...
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2 days following 1st Pfizer vaccine developed burning and stiffness, and pain in joints, followed by severe pain in muscles "all over her body". She had severe headache. She had a fever of 101.9. She had no appetite and "could not eat" . She remained in bed, barely able to walk to the bathroom for 7-8 days. She was "so weak", could not get up. She did not have solid food for 1 week and was not able to take more than sips of liquid. She has continued weakness fever. Now 3 wks following the vaccine, her temp is 100.2.
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| 63 | 2021-03-24 | muscle pain |
Extreme thirst, chills, full body muscle aches, dizziness, extreme fatigue (so much so I could barel...
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Extreme thirst, chills, full body muscle aches, dizziness, extreme fatigue (so much so I could barely keep my eyes open when driving after 8 hours of sleep the night before), nausea, stomach upset. Note: I have not had a flu shot for 25 years, nor have I ever had the flu during that time, but the symptoms do seem flu like. It is now end of day 2 following the 2nd dose of vaccine and I still feel incredibly icky.
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| 63 | 2021-03-25 | joint pain |
Eight days following first shot, my arm started itching near the injection location and two quarter ...
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Eight days following first shot, my arm started itching near the injection location and two quarter sized red spots showed up. This lasted a few days. 2nd shot was Mar 18 at 11 am at same facility. Had severe arm and shoulder blade pain the remainder of the day. Used an ice pack. Mar 19 had slight fever in the morning. Severe arm pain had resolved. Severe achiness in lower back and jaws and general achiness. Started taking Tylenol in afternoon. Vomited at 6pm and 10:30pm. Mar 19-21: Severe headache. Barely ate Mar 19-20. Stayed in bed or resting on couch. Experienced intermittent hiccups. No energy. Headache resolved. Mar 22. Mar 26. Still don't feel 100% normal energy level, but pretty much resolved
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| 63 | 2021-03-25 | joint pain |
same day patient devloped sever shoulder pain in vaccinated arm, chills, fatigue and cough, She was ...
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same day patient devloped sever shoulder pain in vaccinated arm, chills, fatigue and cough, She was unable to work the follwoing 2 days due to severity oif her symptoms. She also reports a mild rash at injection site.
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| 63 | 2021-03-25 | muscle pain, neck pain, joint pain |
Severe aches, fever, chills, joint & muscle pain, headache started coming on about 8 hours after 2nd...
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Severe aches, fever, chills, joint & muscle pain, headache started coming on about 8 hours after 2nd vaccine & got worse through the night. Couldn?t sleep, left arm & left side of neck were sore & hurting in the beginning, then spread to my entire body. (1st vaccine 3 weeks before, no problems except my left arm was sore for a day.) Took ibuprofen & alprazolam before getting in bed & it seemed to help for a short time. My nerves felt like they were on top of my skin. Didn?t sleep much at all, maybe couple hours. Now, 3pm the next day, I?m still very sore, tender all over my body.
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| 63 | 2021-03-26 | muscle pain, muscle tightness |
Muscle ache in both power legs. Bottom and top of right foot extremely painful to walk. Bottom left...
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Muscle ache in both power legs. Bottom and top of right foot extremely painful to walk. Bottom left side of left foot extremely painful. Calves muscles on right leg extremely tight. Top of right foot extremely tight and painful.
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| 63 | 2021-03-26 | muscle pain |
Restlessness, pain at sight of arm, unable to sleep that night, agitated, sweats, heaviness in chest...
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Restlessness, pain at sight of arm, unable to sleep that night, agitated, sweats, heaviness in chest, no care attitude, muscle pain, headache, nausea- emptiness in stomach, possibly swollen lymph nodes. This continued until 6pm the next day (3/25/2021) after receiving the covid vaccine. Should I get the 2nd vaccine, scheduled for 4/15?
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| 63 | 2021-03-27 | back pain, neck pain | Bruise at injection site going on 18 days. More disturbing is aching neck/upper back. |
| 63 | 2021-03-27 | neck pain, back pain |
+Fever blister outbreak (large) upper and lower lips and above and below the lips on right side. Inc...
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+Fever blister outbreak (large) upper and lower lips and above and below the lips on right side. Increased lower back pain on right side. Intermittent pains on the right side of my head, face, neck and ear. Lasted Lasted three days. (Of course, the fever blisters are still healing. - Using medications for these. I had them on hand as I frequently get them but this was a very large outbreak.)
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| 63 | 2021-03-27 | neck pain |
severe neurological symptoms of limb parasthesias gradually decreased over six weeks , vision loss i...
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severe neurological symptoms of limb parasthesias gradually decreased over six weeks , vision loss intermittent left eye for 5 minutes at a time ( 5 events over one month), continued to this day intermittent diplopia vertical , with blurring vision and eye fatigue , general fatigue with ADL ( missed multiple days of work), bouts of tachycardia and palpitations ( slowly abating over 6 weeks ) , original neck pain and headache severe in first 2-3 weeks especially after second vaccine 1/29/21 lot number EL3246. multiple MRI's done brain ( white matter and demylination dating back to before 2015) and cervical and thoracic spine showing existing disc disease all old , neurology work up was done for MS and it was ruled out. visual disturbances persist and neuro-ophthomologist appointment schedule for mid april .
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| 63 | 2021-03-28 | back pain |
Fatigue within 24 hours--as expected. Sunday, March 28, bronchial type cough with lung pain, and pai...
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Fatigue within 24 hours--as expected. Sunday, March 28, bronchial type cough with lung pain, and pain between shoulders. I hope this is just my frequent bronchial response to allergens, but given the proximity to the vac I am reporting. I added guafinessan every four hours at 9 a.m. on March 28, 2021, and am taking it every four hours. It is not lasting a full four hours. I plan to add albuterol, which I have for PRN usage.
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| 63 | 2021-03-29 | joint pain |
Day 1-within 4 lt. shoulder joint with "itchiness,tingling sensation on the left side from elbow thr...
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Day 1-within 4 lt. shoulder joint with "itchiness,tingling sensation on the left side from elbow through shoulder, back of neck down through trap /shoulder blade into serratous area of ribcage (treated with Tylenol, Aleve and Benadryl) Day 2- 24 hours later left joints, shoulder, elbow, hand progressively worse, one incident of tachycardia, Itching continued and progressed to left side of face, (treated with Tylenol, Aleve and Benadryl) Day 3- 48 hours later more significant bil. joint soreness in knees, hands/thumbs, shoulders, elbows- itchiness/tingling sensation continued on left side (treated with Tylenol, Aleve and Benadryl) Day 4- joint pain continues as well as itching/tingling (treated with Tylenol, Aleve and Benadryl)
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| 63 | 2021-03-29 | neck pain, back pain |
On Wednesday during the night in the middle of night with a feeling that her right ear was on fire. ...
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On Wednesday during the night in the middle of night with a feeling that her right ear was on fire. It hurt under the ear in a straight line about 3-4". The next day she had the same hurting, the straight line, but then the pain started to go around the back of her neck and up the right side of her head. That was this way Thursday and Friday. She got into her chiropractor, seemed to be a little better after that. She got up Saturday morning and took a drink of water and it came right back up, and looked in the mirror and saw that her face was drooping, and worried she was having a stroke and went to the ER at the Hospital. They did stroke protocol in the ER and they determined that she was not having a stroke but was having Bell's palsy. Gave her some medications (steroids and antiviral) and told her to see her PCP. She saw her PCP yesterday and he advised her to get the vaccine and advised her about Guilllain Barre.
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| 63 | 2021-03-29 | neck pain | Extreme Injection site swelling, pain, redness, hot, body aches, chills, headache, neck ache. |
| 63 | 2021-03-30 | bone pain |
sore arm, big welt, big knot,felt like, headache, body aches, bones aches, muscle spasms, kidney inf...
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sore arm, big welt, big knot,felt like, headache, body aches, bones aches, muscle spasms, kidney infection
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| 63 | 2021-03-30 | flank pain, back pain |
dysuria; abdominal pain; pelvic pain; bladder spasms; left flank, low back and upper back pain; left...
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dysuria; abdominal pain; pelvic pain; bladder spasms; left flank, low back and upper back pain; left flank, low back and upper back pain; headache; This is a spontaneous report received from a contactable nurse. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL0142) via an unspecified route of administration left arm on 14Jan2021 08:15 at single dose for COVID-19 immunization. Medical history was not provided. Concomitant medications included colecalciferol (VITAMIN D) and vitamin b complex. Patient previously took BNT162B2 (lot number: Eu1685) on 23Dec2020 07:45 to Left arm for COVID-19 immunization. On 26Jan2021 Lab data was reported as PCR test, Nasal Swab and Veritor rapid test results were negative. On 15Jan2021 the patient experienced with dysuria, abdominal pain, pelvic pain, bladder spasms, left flank, low back and upper back pain, headache. Patient received Bactrim, Toradol and Advil as treatment for events. Seriousness was reported as non-serious. Outcome of events was unknown. No follow-up attempts are possible. No further information was provided.
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| 63 | 2021-03-31 | joint pain, back pain |
Approximately 10 minutes after the vaccine was administered I became nauseous which lasted until bed...
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Approximately 10 minutes after the vaccine was administered I became nauseous which lasted until bedtime 9:00 pm. 20 minutes after the vaccination I felt a tingling sensation on the left side of my face which proceeded down the left side of my body to the top of my foot which I still have now been the following day (18 hours at the time of filling out this survey 10:30 am on 4/1/21). Approximately one hour after the vaccination I became achy at the injection site, along my lower back and knee joints. Soon after (30-45 minutes) I became chilly and spiked a slight fever (99.6) which subsided after taking 250mg of Tylenol.
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| 63 | 2021-03-31 | joint pain |
passed out; Unfortunately hit my head.; felt light headed; slightly nauseous; intense right knee pai...
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passed out; Unfortunately hit my head.; felt light headed; slightly nauseous; intense right knee pain; temperature of 99.6; flu-like symptoms; This is a spontaneous report from a contactable Other Health Professional (patient). A 63-year-old non-pregnant female patient received bnt162b2 (Pfizer Brand COVID 19), dose 2 intramuscular, administered in left arm on 26Feb2021 12:00 (Lot Number: EN6198) as single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient was not diagnosed of Covid prior vaccination and has not been tested for Covid post vaccination. The patient has no known allergies. Concomitant medication included levothyroxine, liothyronine (NP THYROID) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Pfizer Brand COVID 19), dose 1 intramuscular, administered in left arm on 05Feb2021 11:30 AM, (Lot Number: EM9810) for COVID-19 immunisation. There was no other vaccine in four weeks. On 27Feb2021 07:45, the patient passed out, unfortunately hit head, felt light headed and slightly nauseous. It was also reported that patient had intense right knee pain, a temperature of 99.6 and flu-like symptoms. The events were also described as follows: 18hrs after the injection, I had intense right knee pain that lasted for 24hrs. Also in that same time period, I felt a huge rush of energy come over me and passed out. Unfortunately hit my head. I had a temperature of 99.6 and flu-like symptoms that lasted 24hrs. For 4 days I felt light headed and slightly nauseous but that could have been due to hitting my head. Called 911, EMT evaluation and the patient received treatment for events. Outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events and other events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified, as appropriate.
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| 63 | 2021-03-31 | joint pain |
Tingling on her lip/ zap or electrical like feeling in her upper lip; tingle on the right hand finge...
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Tingling on her lip/ zap or electrical like feeling in her upper lip; tingle on the right hand finger/ electrical feeling; sharp pain in her breast/ painful zinging sensation on her right breast; excruciatingly painful electrical feeling like a zing that shot from her left foot and ankle to her calf; pain that came up the outside left ankle/ zinging sensation left ankle; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration in the left arm on 02Mar2021 11:00 AM as a single dose for COVID-19 immunisation. Medical history predating treatment with the Pfizer COVID 19 vaccine included fracture on that left foot where the toenail came off and she had a wound that wouldn't heal. She was fully recovered from the foot injury in Dec2020. Then she came down with a positive COVID 19 test on 11Dec2020. Symptoms started on 07Dec2021 with a fever and everything and she ended up in the ER with bilateral pneumonia and they sent her home on 17Dec2020. Then later, she was admitted to the hospital on 25Dec2020 with excruciating pain in her chest, lungs and legs; and she was having shortness of breath. She was found to have a DVT, PE and bilateral pneumonia. She was discharged 30Dec2020. She thinks she has the long time syndrome after COVID. She was still having shortness of breath, itchiness, and extreme fatigue from the COVID 19 infection but her HCP advised her to get the COVID 19 vaccine anyway. She thinks the chest congestion and cough were cleared up now, but she has noticed hair loss. The patient had no concomitant medications. The patient stated that her husband, son and herself received the first dose of the Pfizer COVID vaccine on 02Mar2021. They all waited the 15 minute waiting period after receiving the vaccine for a reaction and was fine. Her husband and son went ahead to the car and she went to use the restroom. 20 minutes later, while in the restroom, she got a random ting outside her left foot like an electrical type very painful pain that came up the outside left ankle, leg, and calf. She had an excruciatingly painful electrical feeling like a zing that shot from her left foot and ankle to her calf/ zinging sensation left ankle on 02Mar2021. The pain was from the same foot that she had broken before. It happened once and she was like what was that and then it stopped. Maybe 5 seconds went by then it happened again this random zap of electrical feeling that she cant really explain but it gave her whole body goosebumps. It did it 5 times in a row with pauses in between in the same exact place left lower leg. After it stopped and as she was washing her hands she had a really sharp pain in her breast on 02Mar2021 and then that was it. She walked out to the car and she didn't say anything to her husband or son because she didn't really understand what was happening and she felt fine other than the crazy pain and once it ended it ended. When she got home and in the afternoon because she was home working remotely it happened again the same exact spot left lower leg and the pain was excruciating when it was happening. This time she thinks it was four times in a row with pauses in between same exact spot just in her left lower leg. This time she told her husband "I didn't say anything before but its happening again and its weird." She never had this feeling before. Adds it was so excruciating. She was just holding her breath counting how many times it will occur. It happened again that night and then she almost afraid to go to sleep because the pain would wake her up but nothing happened as she slept. She woke up the next morning and had to go to an ophthalmologist appointment and happened again while she was sitting in the chair. She had another episode of the painful zing in her foot. That was the last time it did and it might have happened again but altogether she had 4-5 episodes in a 24 hour period after receiving the vaccine. Each time she would have several painful zings. She also noticed a tingling on her lip on 03Mar2021; a painful zinging sensation on her right breast; and a tingling sensation on one finger of her hand that happened one time on 03Mar2021. That day, she had a tingling in one finger and a zap or electrical like feeling in her upper lip and that was it those didn't really bother her they were more tingling and electrical feeling. She called her primary doctor and he hadn't heard of anything like it before but he cant rule it out. He said the only way you would know is if you got the shot again but she states she is a little scared. She would like to know if this side effect has been reported before and if she should get the second dose of the vaccine. She was scheduled to receive the next dose on next Tuesday, 23Mar2021. She mentioned she had blood work this week but she has no results at this time. The outcome of sharp pain in her breast/ painful zinging sensation on her right breast was recovered on 02Mar2021, of excruciatingly painful electrical feeling like a zing that shot from her left foot and ankle to her calf was recovered on 03Mar2021, of pain that came up the outside left ankle/ zinging sensation left ankle was recovered on 04Mar2021, of tingling on her lip/ zap or electrical like feeling in her upper lip was recovered on 03Mar2021, and of tingle on the right hand finger/ electrical feeling was recovered on 03Mar2021.
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| 63 | 2021-03-31 | back pain, muscle pain, joint pain |
Woke up with extreme pain by my shoulder blade, down my arm on March 13th. Used NSAIDS for a couple ...
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Woke up with extreme pain by my shoulder blade, down my arm on March 13th. Used NSAIDS for a couple of days with no relief. Went to ED Triage nurse to ask for guidance on next steps. Went to urgent care on 3/15/21 and was prescribed muscle relaxers for muscle pain with no relief in my shoulder and arm. Appointment with orthopedic doc, on 3/17/21. He ordered an MRI of C-spine and diagnosed nerve pain. Pain traveled from arm to hand and back to shoulder then repeated 24/7. Used ice-packs, and alternated with heat. Second appointment with Dr. on 3/23/21. Discussed nerve pain and Parsonage Turner Syndrome.
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| 63 | 2021-04-01 | back pain |
3 days after 1st vaccine...tingling in top of scalp my hair follicles hurt 1 week after 1st vaccine....
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3 days after 1st vaccine...tingling in top of scalp my hair follicles hurt 1 week after 1st vaccine...spasms in left leg above knee cap [right hip was replaced in 2010 w/titanium hip] 8 days after 1st vaccine...lower lumbar pain left side 9 days after 1st vaccine...severe pain in upper thigh left side...could not walk...had to lay down for comfort took ib prophen 10-12 days later...left leg ached down to shin 13 days later...went to orthopedic dr...gave me steroid & muscle relaxer & stretches 21 days later...received 2nd vaccine...had to take it prophen for pain relief 26 days later...went to pain Dr wanted an MRI but was declined...continued to stretch Told both Drs about vaccine & nerve reaction but the didn't think it was related. 35 days later...absolutely no pain & can walk and sit normally
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| 63 | 2021-04-01 | musculoskeletal chest pain | tiredness, nausea, pain on lower ribcage, diarrhea,gas |
| 63 | 2021-04-01 | muscle pain |
I felt nauseous, extremely tired, headache, muscles ached especially in the arms for a day, enough t...
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I felt nauseous, extremely tired, headache, muscles ached especially in the arms for a day, enough to be incapacitated.
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| 63 | 2021-04-01 | neck pain, muscle pain |
onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue,...
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onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). I knew I had Bell palsy; Awakened with brief episode (10 min) severe abdominal pain; Severe muscle aches; Head pain; Neck pain; Developed sore on left side of tongue; Neck/mastoid pain; Swollen gland lasted a few days; This is a spontaneous report from a contactable other HCP (patient). A 63-year-old (non pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6200, Expiry Date: unknown) via an unspecified route of administration in left arm on 24Feb2021 13:30 at single dose for COVID-19 immunisation. Patient had historical vaccine at 63-year-old BNT162B2, lot number: EL9262 at left arm on 03Feb2021 13:30 at SINGLE DOSE for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's medical history included penicillin and neomycin allergy. Patient's concomitant medications included ergocalciferol (VIT D), rosuvastatin calcium (CRETOR) (medications the patient received within 2 weeks of vaccination). On 25Feb2021, the patient experienced onset of symptoms of left-sided bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). I knew I had bell palsy, awakened with brief episode (10 min) severe abdominal pain, severe muscle aches, head pain, neck pain, developed sore on left side of tongue, neck/mastoid pain, swollen gland lasted a few days. Event was reported as on 25Feb, patient awakened with brief episode (10 min) severe abdominal pain. Later, severe muscle aches, head and neck pain, lasted until following Wednesday (03Mar). Patient developed sore on left side of tongue, neck/mastoid pain, swollen gland; lasted a few days, then noted onset of symptoms of left-sided Bell palsy (twitching, paralysis, lost of taste/sensation of tongue, lid lag etc). By friday 12Mar she knew she had Bell palsy. Medrol dosepak, OTC pain meds was received as treatment for adverse events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The outcome of event was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Bell's palsy and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI and viral serology, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-04-02 | joint pain |
Nausea immediately following injection and burning in throat. Next day, extreme joint pain throughou...
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Nausea immediately following injection and burning in throat. Next day, extreme joint pain throughout entire body.
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| 63 | 2021-04-02 | muscle pain |
Approximately 18 hours of intermittent low grade fever, also suffered extreme fatigue and overall mu...
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Approximately 18 hours of intermittent low grade fever, also suffered extreme fatigue and overall muscle soreness. Took 2 Advil to help with fever and muscle soreness
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| 63 | 2021-04-03 | musculoskeletal stiffness | I got a stiff neck within 24 hours of my first dose. It is 3 weeks later, and I still have it. |
| 63 | 2021-04-03 | musculoskeletal stiffness |
1st shot was similar, it felt like something popped and my sinuses got crazy, my eyes got watery and...
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1st shot was similar, it felt like something popped and my sinuses got crazy, my eyes got watery and swollen, my throat was like a stiff neck, my head hurt so bad i was taking tylenol every 4 hours, at night i got a fever and my husband said i was crying for a blanket, I think I might have gone back to when i was at the hospital, I don't know, we both couldn't walk or move everything hurt so bad. The second shot was worse than the first.
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| 63 | 2021-04-04 | joint pain |
breathing issues, tightness in chest, fatigue, joint pain, fever, chills,, migraines all lasting mor...
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breathing issues, tightness in chest, fatigue, joint pain, fever, chills,, migraines all lasting more than 4 weeks.
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| 63 | 2021-04-04 | back pain |
swollen glands plaque in the throat pain in the lower back fever dizziness tiredness nausia poor app...
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swollen glands plaque in the throat pain in the lower back fever dizziness tiredness nausia poor appetite I didn't go to the doctor because I don't have insurance
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| 63 | 2021-04-05 | muscle pain |
Pfizer COVID Vaccine EUA Patient received 1st dose of Pfizer vaccine 3/11/21. 3/27/21: Patient is ...
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Pfizer COVID Vaccine EUA Patient received 1st dose of Pfizer vaccine 3/11/21. 3/27/21: Patient is a pleasant 63-year-old female past medical history of anxiety, documented history of hyperlipidemia came in from outside facility with complaints of dyspnea, COVID-19 pneumonia, bradycardia. Clinical picture started on the 17th patient tested positive for COVID-19 at that time was having symptoms myalgia, subjective dyspnea reportedly went to the emergency department, saturations were good she was discharged home with conservative measures. At home became more symptomatic and pulse ox was measuring in the low 80s so she went back to the hospital and was admitted to Hospital on 03/25. Per records patient was started on Eliquis, dexamethasone, azithromycin, remdesivir, p.r.n. Tylenol, p.r.n. Zofran, p.r.n. Toradol along with supplemental oxygen. Oxygen requirement was 5 L at the facility. However overnight and prior to arrival providers at outside facility started noticing bradycardia patient's heart rates were dropping into the 30s. Patient was asymptomatic during these episodes not complaining of any lightheadedness or chest pain. Reportedly cardiologist saw patient QT and QTC were reportedly appropriate recommended monitoring. However overnight heart rate continued to go down into the 30s, reportedly on telemetry was noted to be developing Mobitz 2 second-degree block, patient was administered atropine x2 and heart rates improved to the 70s however a year started going down again to 30s and 40s after a couple of hours. Outside facility requested transfer to another hospital for further management and possible EP intervention. Bedside patient is lying comfortably in bed currently denies any lightheadedness, dizziness, chills, fevers, nausea, vomiting, diarrhea, chest pain, palpitations, paresthesia, swelling of extremities. Though is she gets winded after exertion, is okay/comfortable on supplemental oxygen at rest. Patient was increased to 8 L during ambulance ride, was id saturating however medics increased because of bradycardia. Otherwise denies tobacco, recreational drug/marijuana, over-the-counter/herbal medication use. Social consumption of alcohol will have 1-2 beers a year. She reports sick contact 1 of her close friends was diagnosed with COVID earlier this month, husband also positive. She reports she received 1st dose of COVID-19 vaccination around the 10th or 11th of this month 1 day prior to known exposure. Otherwise no medication changes is only on sertraline. Currently no antihypertensive medication or rate-controlling agents. 4/1: Patient was admitted after developing significant bradycardia after receiving remdesivir for COVID-19 pneumonia. Remdesivir was held and patient received convalescent plasma on 03/28. Dexamethasone was started at the outside hospital on 03/25. With also completed 5 days of empiric doxycycline and Rocephin. Patient CRP and D-dimer were followed and trended down at the time of discharge. EP Cardiology was consulted and initially the patient was on dopamine for the 1st 2 hospital days. Was able to be stopped and the last 2 hospital days the patient had no bradycardia. She will have a Holter monitor as an outpatient. Patient wore her BiPAP at night. Oxygen requirements trended down and was able to be on room air at the time of discharge. Home O2 evaluation was performed and did not require oxygen. She will continue on 5 further days of Decadron 6 mg daily. She will follow-up with her PCP.
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| 63 | 2021-04-06 | joint pain, neck pain |
Horrific pain in left arm, shoulder, neck every day since the first injection. Pain is 24/7, ongoi...
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Horrific pain in left arm, shoulder, neck every day since the first injection. Pain is 24/7, ongoing, causes lack of sleep, severe discomfort, inability to function
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| 63 | 2021-04-06 | muscle pain |
Smelling roast beef and cotton candy (phantosmia - or olfactory hallucination); Severe headache; Mus...
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Smelling roast beef and cotton candy (phantosmia - or olfactory hallucination); Severe headache; Muscle aches; Chills; Fatigue; This is a spontaneous report received from a contactable pharmacist reporting for herself. A 63-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534), via an unspecified route of administration on 23Mar2021 10:00 at single dose for COVID-19 immunization. Medical history reported as none. Concomitant medications included calcium carbonate (CALTRATE), ascorbic acid, retinol, tocopherol (OCUVITE). Historical Vaccine included first dose of BNT162B2 (Lot number EN6203) on 23Mar2021 at 10:00 AM for COVID-19 immunization. The patient experienced Smelling roast beef and cotton candy (phantosmia - or olfactory hallucination), Severe headache, Muscle aches, Chills and Fatigue on 23Mar2021 20:00. Treatment received for event headache included Tylenol 1grm at 9:30 am 3/24. The outcome of the events were resolving. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported event parosmia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-04-09 | musculoskeletal stiffness |
arm started swell a little bit; woke me up at 5 O'clock this morning in pain; arm started swell a li...
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arm started swell a little bit; woke me up at 5 O'clock this morning in pain; arm started swell a little bit; woke me up at 5 O'clock this morning in pain; shoulder is kind of swollen; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; shoulder is kind of swollen, it's got big old knot and it's red and it's apparent itchy; arm kind of still stiff and sore; Blood in stool; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613 and expiration date not provided) via an unspecified route of administration administered in the arm, on 23Mar2021 as a single dose for COVID-19 immunization. Medical history included breast cancer survivor. The patient's concomitant medications were not reported. The patient stated that she was trying to figure out what to do. On 26Mar2021, her arm started to swell a little bit. When she woke up, it woke her up at 5 o'clock in pain and her shoulder was kind of swollen, it has got big old knot and it was red and it was apparent itchy and she could not scratch it so, she thought about it and she got an ice pack, so she put ice on it. She was holding ice on it now, trying to sooth it. She was wondering where she would go for reaction, she knew she had reaction like this before so she had a side effect from it, and her arm was kind of still stiff and sore. She did not go to the emergency or urgent care because she looked at left and she looked at the right and like she said, it was swollen and she got big old knot and it was red. She also stated that she did not take Tylenol today. She did not know what she wanted to get through to somebody and she needed to speak to somebody on what she needed to do. She also said that on an unspecified date in Mar2021, in her stool, she found some blood. She had another appointment with her "thyroid" (not clarified) and she does not know the results yet. The outcome of the events was not recovered. Information about lot/batch number has been requested.
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| 63 | 2021-04-10 | muscular weakness |
Progressive ascending weakness (R>L) with urinary retention. MRI spine showing T6-conus longitudinal...
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Progressive ascending weakness (R>L) with urinary retention. MRI spine showing T6-conus longitudinally extensive non-enhancing lesions and minimally enhancing 3x 2.3cm L thalamic lesion. Differential diagnosis includes post-infectious vs post-vaccine autoimmune demyelinating process such as ADEM-like picture with transverse myelitis vs paraneoplstic process. Lower suspicion for primary CNS lymphoma. -s/p brain biopsy 4/7/21 -s/p 5 plasma exchanges with two more planned
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| 63 | 2021-04-13 | joint swelling |
2/28/21 Four days after 1st Pfizer vaccine 2/24/21 Severe cramping and swelling in my right leg ...
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2/28/21 Four days after 1st Pfizer vaccine 2/24/21 Severe cramping and swelling in my right leg and ankle. 3/9/21 Work clinic advised to seek medical attention 3/9/21 Hospital Emergency Room Diagnosis: Deep Vein Thrombosis (DVT)- Blood Clot 3/10/21 Thrombectomy Surgery & Released 3/11/21 Swelling in right leg and ankle Returned 3/12-16/21 Readmitted - Blood Clot returned Currently under several doctors care.
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| 63 | 2021-04-15 | joint pain |
Started with arm being very sore at vaccination site, thrm developed a round red spot at vaccine sit...
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Started with arm being very sore at vaccination site, thrm developed a round red spot at vaccine site which is becoming bigger. Also, have a canker side in my throat-I send to get them as a child, in my throat. Also, broke my knee cap 2 years ago and it had become painful
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| 63 | 2021-04-24 | grip strength decreased, joint pain, rheumatoid arthritis |
Pain in elbow; Trigger finger; Rheumatoid arthritis flare up; Grip strength decreased/could not make...
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Pain in elbow; Trigger finger; Rheumatoid arthritis flare up; Grip strength decreased/could not make fist or grasp or grip/ inability to grip or grasp with her hands; pain in arm; right ear & head pains; right ear & head pains; This is a spontaneous report from a contactable nurse, the patient, and based on information received by Pfizer from Abbvie Pharmacovigilance (Mfr. Control No.: 21K-163-3848385-00). A 63-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6207) intramuscular in the right arm on 18Mar2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunization; adalimumab (HUMIRA) solution for injection, subcutaneously, from an unspecified date at an unspecified dose and frequency for rheumatoid arthritis (RA). Medical history included polymyalgia rheumatica (PMR), RA, hypothyroidism, anemia. The patient had no known allergies. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included prednisone, levothyroxine sodium (SYNTHROID), folic acid, calcium carbonate (CAL). The patient did not receive any other vaccinations within 4 weeks of BNT162B2. On 18Mar2021 (within 4 hours of the vaccination), the patient experienced a rheumatoid arthritis flare up. The clinical course was as follows: on 18Mar2021 at 15:00, the patient experienced pain in elbow and finger pain (like trigger finger of both hands). On Mar2021 (within 24 hours), all fingers were involved, the patient's grip strength was decreased (she could not make a fist or grasp or grip/ inability to grip or grasp with her hands) and experienced left wrist pain. On Mar2021 (within 48 hours), the patient experienced finger edema, was still unable to make fist or grasp, experienced painful shooting pains up inner arms, right ear & head pains. The patient increased the prednisone dose to 4 mg daily as treatment for the events. On 21Mar2021 at 11:00 (72 hours after vaccination), the patient continued to experience bilateral arm pains, slight hand grips but could not lift, new right knee and right outer foot pains. On 21Mar2021 (94 hours after vaccination), there was less arm pain and finger edema, continued right ear/head pains. The patient saw the primary physician, there was no ear infection and the physician agreed with the prednisone increase. The physician felt the patient should not take the second vaccine dose and alerted the rheumatologist. On 22Mar2021 (116 hours after vaccination), the patient was able to lift and grasp with both hands, had less ear and arm pain. Since the vaccination, the patient was not tested for COVID-19. The action taken with adalimumab in response to the events was unknown. The reporter's causality for the events trigger finger, inability to grip or grasp with her hands, severe flare of RA symptoms 4 hours post vaccine, pain in arms and elbows, pain in ears was not provided. The clinical outcome of rheumatoid arthritis flare up, trigger finger, "grip strength decreased/could not make fist or grasp or grip/ inability to grip or grasp with her hands", pain in arm, right ear & head pains was resolving; while of pain in elbow was unknown.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the RA flare and other events. The reported events may likely represent intercurrent medical conditions. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 63 | 2021-04-24 | musculoskeletal stiffness, joint pain |
some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headach...
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some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headaches; left sided neck and shoulder stiffness; acute weakness; tiredness; severe chills throughout my whole body; generalized severe body aches; extreme joint pains; her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains; numbness; tingling sensations; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 15:30 (Batch/Lot Number: ER 8737) as single dose, for covid-19 immunization. Medical history included chronic interstitial cystitis, hypertension, COVID-19 flu in Jan2021. Concomitant medications included telmisartan (MICARDIS) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (TOPROL) taken for an unspecified indication, start and stop date were not reported. within the first 15 minutes of observation, the patient did not have any anaphylactic symptoms from the covid-19 flu shot. But as patient was driving home, at around 15:45, her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains and numbness and tingling sensations. By around 19:00 that same day, she began having severe headaches, left sided neck and shoulder stiffness, acute weakness and tiredness, severe chills throughout my whole body, with generalized severe body aches, and extreme joint pains, BP of 200-210/100- 110, irregular heart palpitations and some delirium episodes x 2 days. The outcome of events was reported as recovering. The patient has been treating herself with OTC Tylenol and motrin as the result of the events. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the delirium, hypertension and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 63 | 2021-04-24 | muscle pain |
could not sit down; She could not sit down and sleep before; muscle pain in right leg, from right fo...
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could not sit down; She could not sit down and sleep before; muscle pain in right leg, from right foot and traveled up to knee/It came on and off/the pain was unbearable/The muscle pain at first was on the right leg only and last night it was both legs.; Right arm soreness; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 63 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534) via intramuscular, administered in arm right on 25Mar2021 14:30 as single dose for covid-19 immunisation. Medical history included high cholesterol. She is pretty healthy. No vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Concomitant medications included pravastatin (40 mg tablet) for high cholesterol taking for 2 years and stopped since Friday (unspecified date); Vitamin D. After having the first injection at a hospital, patient did not feel anything, just a little right arm soreness (25Mar2021 14:30). But exactly a week after, on Thursday (30Mar2021), she started to feel muscle pain in her right leg, from right foot and traveled up to knee. It came on and off. She did not take any medication. But Friday (02Apr2021) it got worse, she took only one paracetamol (TYLENOL Arthritis PAIN 650 mg, Count size 24 caplet, Lot: SLA055, Expiration: Jul2023) and felt okay. On Saturday (03Apr2021) happened again, she also took one in the morning and at night. On Sunday (04Apr2021), she felt again in morning took 1 paracetamol and at night she took another one, the pain was unbearable. Next Monday (05Apr2021), she almost called 911 at 7pm but she didn't do it, her neighbor is a nurse for 46 years and she told her to take two paracetamol. Last night (05Apr2021), she took two. She could not sit down and sleep before (Apr2021). She was able to sleep. This morning she felt it again (06Apr2021), her neighbor told her to take 2 for 3 times or every 6 hours. She took 2 this morning. She is scared. She called her doctor. She was going to call 911 last night because the pain was bad and she was scared. The muscle pain at first was on the right leg only and last night (05Apr2021), it was both legs. She needs the right medicine. The doctor said she should call Pfizer and discuss. She wondered if it is okay to take second dose and what the right medication is to take to help with the pain. Patient did not visit emergency room. The patient assessed the report as serious. Outcome of muscle pain in legs was not recovered, outcome of other events was recovering. No follow-up attempts are needed. No further information is expected.
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| 63 | 2021-04-24 | neck pain, back pain |
couldn't get out of the bed as the pain all the way down to her back was killing her, like it was pa...
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couldn't get out of the bed as the pain all the way down to her back was killing her, like it was paralyzing her; allergic reactions; Swelling in the face; hives on her back; itching that was in her back; Neck and back pain were pretty intense; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8729), via an unspecified route of administration on 02Apr2021 at a single dose for covid-19 immunization. Medical history was reported as many medical conditions, names unknown, just a combination of medical problems. The patient was taking unspecified concomitant medications, some of which were taken in the morning. The patient had the vaccine on 02Apr2021 (reported as "Friday or Saturday") in the afternoon and had a bad adverse reaction to it. The patient had swelling in the face, hives on her back, itching that was in her back, and, allergic reactions on 02Apr2021. Due to these, since she was just in a medical facility, doctor and nurses over there were able to inject her with Benadryl that was a strong dose, in a long needle given into the muscle and stuff. It was good enough that she got up and was sent home. She then seemed to be fine but on Monday, 05Apr2021, she couldn't get out of the bed as the pain all the way down to her back was killing her, like it was paralyzing her. She could not even get out of the bed for like hours. The neck and back pain on Apr2021 were pretty intense, and she does not know where and how it came so she was trying to figure that out and realized she just recently had the vaccine injection. She knew that there could be some kind of reaction, but she was not sure if it were from the vaccine. She wanted to make sure she did not get something serious because she already has rare conditions. She added she did not have any prior treatment for these because she did not even think like this was even a side effect of the Pfizer vaccine but now she was wondering if it was because she had not taken anything prior. She does not know if it was related or not and she was concerned about it. She wanted to know what she could do if these were side effects because she knew there were some people that have something to do with the spinal cord and she was not sure if their symptoms were like hers or not. She wanted to know if she would need treatment for it and if it was an adverse reaction. She added that the swelling in her face and, itching that was in her back went away the same day when she was given the vaccine. The outcome of the events swelling in the face and itching that was in her back was recovered on 02Apr2021. The outcome of the other remaining events was unknown.
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| 63 | 2021-04-24 | neck pain |
Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; ...
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Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; have massive diarrhea; had a sore throat and could not swallow or eat; menstrual cramps; felt alot of extreme fatigue; felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it; sinus pain; her face and eyebrows hurt; throw up viscously that it is almost coming out of her nose and also went to sheer panic/vomiting; she is not speaking well or understood well; profusely sweating and had whole body sweat drenched on the floor; ice-cold ends; painful arm; baseline temperature is 94.6; Neck pain; Woke up Monday morning and couldn't get out of bed, wanted to die; Caller states she is losing her mind; had her gripping her pelvis because of the pain; sheer panic.; woke up with gut ripping food poisoning; still very tired; couldn't get out of bed; had a sore throat and could not swallow or eat; feel nauseous; feeling dehydrated; her head because of the ache; getting sick; nausea; experienced severe headache which led her to stay in bed all afternoon/her headache is more severe and describe it as she would like to shot her head because of the ache; has a flu-like chills; body ache symptom which comes and go; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration in arm left on 21Mar2021 as single dose for covid-19 immunisation. Medical history included taking a anti-HTN medicine (beta blocker) and had slowly been weaned off of that prior to getting his shot as her cardiologist is afraid that it might affect the efficacy of the vaccine shot and had not been put back in any BP regulating meds until then and quite concerned because of her fluctuation BP. anxiety and gets to panic immediately, also is disabled and doesn't live with any nearby family, has allergies to alot of foods. State she comes from family of strokes, heart attacks, and high blood pressure and one of her biggest fears is having a stroke. States her boyfriend has a family of strokes too, 2 blood pressure medicines, which contain polyethylene glycol (PEG). and concomitant medications not reported. The patient stated after 1 week of getting the vaccine- getting sick, felt alot of extreme fatigue, felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it. On 03Apr2021 experienced severe headache which led her to stay in bed all afternoon, she also has a flu-like chills body ache symptom which comes and go. On 04Apr2021 experienced nausea and took Tylenol for feeling so sick and felt well 2 hrs after. On 05Apr2021 woke up feeling all the symptoms like the other days, her headache is more severe and describe it as she would like to shot her head because of the ache, she also had a sore throat and could not swallow or eat for 2 1/2 days, she also feel nauseous and throws up water already, she already was feeling dehydrated. After which she called her doctor and mentioned that no organization or her doctor cant guide her well with regards the symptoms that she is feeling if this is common after receiving the vaccine. She asked her doctor and her doctor said that it could probably be a symptom of COVID19 infection. So she got tested and turned out she had a negative result. After a while she also experienced some sinus pain that was not normal for her, she also mentioned that her face and eyebrows hurt. She went to her ENT and ENT who she trusted and respected a lot as a surgeon because according to her is very well versed mentioned that these are not normal side effects that she is experiencing. She also consulted with a brain surgeon and the brain surgeon mentioned that if the side effects won't go away , advised that she need to go to an ER and that doctor feared that he could be having stroke or meningitis. In shock, patient called her cardiologist again and cardiologist advised her not to be alarmed about brain surgeon's advised. She was back to her BP management medication for 2 days already and cardio advised that she should get the vaccine still. On Wednesday and Thursday- her sinus pain went away she had experienced the worst pain ever and had her gripping her pelvis because of the pain, she also have massive diarrhea, had nausea and throw up viscously that it is almost coming out of her nose and also went to sheer panic. Also felt that she almost faint, not dizzy not vertigo type for under a minute. Called her neighbor and neighbor said that she is not speaking well or understood well. She was profusely sweating and had whole body sweat drenched on the floor. Called her physician and physician said that it could be food poisoning. Patient even said that she is not blaming the above event with Pfizer. Also mentioned she experienced sore throat in between. Patient states she is losing her mind, she is a highly anxious and panicky person, she was worried about getting the vaccine at first, but went ahead with it. States she has removed herself from her blood pressure medication, Bystolic, because there is an ingredient in there that is a beta blocker, polyethylene glycol or polysorbate or something. Worried of having an anaphylactic reaction now after the vaccine to the medication, states she has allergies to alot of foods. Patient states she had a very painful arm at first, that she had no symptoms for the first four days, states a week later she started getting sick, states last Saturday symptoms worsened significantly, that she had a headache and it wouldn't go away for 4-5 days, nausea, vomiting a couple of days, dehydration, a little diarrhea, chills, mild body aches. One day she was down for the count, then on Easter Sunday she took a Tylenol and was better. Later in the afternoon the nausea came back. Woke up Monday morning and couldn't get out of bed, wanted to die. States her baseline temperature is 94.6 and she went all the way up to 98 it was rising, body aches, sore throat. Went and got tested for Covid, flu, and strep and were all negative at urgent care. There the doctor told her because of her neck pain that she says she has had for years, she could die of a stroke or meningitis and so she called her ENT and they told her to wait a couple days and then to go to the emergency room if she was not better and the headache does not go away soon. patient states she does feel better today, only last night she woke up with gut ripping food poisoning, like she had the flu, Had worst menstrual cramps in that area, then she was throwing up, had diarrhea, felt like she was going to faint, went into this ungodly sweat. Saw on news that more people are getting sick a week or more after the shot, did not mention which shot they received. States she has a previous disability and a broken foot. Today she is feeling fine, just still very tired. experienced side effects between 1-1.5 weeks after the injection. She listed the following symptoms: headaches, chills, nausea, a sore throat, fatigue, ice-cold ends, vomiting, and diarrhea. She specified her sore throat was from hell, her temperature was up, but she had no fever, and both the vomiting and diarrhea were little. She added last Saturday was when she felt sick the most and it lasted 4-5 days. She said she tested for COVID-19 and the Flu. She specified the doctors also thought she had a stroke then meningitis. She explained she spoke with 3 doctors but feels like she's on her own to determine whether she should get the second dose. The patient underwent lab tests and procedures which included body temperature: up, body temperature: 94.6, body temperature: 98, influenza: negative, sars-cov-2 test: negative, streptococcus test: negative. Seriousness was non-serious. The outcome of the events was unknown.
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| 63 | 2021-04-27 | joint pain, neck pain, back pain |
her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got ...
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her throat got swollen; burning sensation at the site; tiredness; achiness all over; her throat got red; could not sallow; her lymph nodes in the neck were swollen, they hurt really bad; Her lymph nodes in the neck were swollen, they hurt really bad; had pressure in the ears; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; ain in the shoulder, back of the head, in the back and in the neck; This is a spontaneous report received from contactable consumer (patient). A 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 63-year-old) for covid-19 immunisation. Medical history included COVID-19, she was tested positive for COVID in Jan2021. The patient's concomitant medications were not reported. On an unspecified date she experienced burning sensation at the site (that went away), later experienced tiredness, achiness all over, and her throat got red and swollen, could not sallow, she felt like getting COVID again after the vaccine. Her lymph nodes in the neck were swollen, they hurt really bad, had pressure in the ears, pain in the shoulder, back of the head, in the back and in the neck. She wanted to know if she should to get the second dose or not, if she can get the shot in the gluteal or other sites. The event her throat got swollen was considered medically significant. The outcome of Vaccination site burning was recovered, of all other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 63 | 2021-04-28 | muscular weakness |
Stroke; MRI showed Pontine Stroke; left arm was weak; her writing looked like a baby's scribble/she ...
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Stroke; MRI showed Pontine Stroke; left arm was weak; her writing looked like a baby's scribble/she cannot write or type; arm was sore; she sounded different; they said her speech sounded slurred; was prediabetic before her hospitalization with her number (A1c) usually being 6.5-6.8. She added that when she was in the hospital it was 7.4; was not able to walk at first; her arm was cold; This is a spontaneous report from a contactable consumer (patient) reported that a 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), via an unspecified route of administration on 24Feb2021 08:00 (at the age of 63-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included high blood pressure that was diagnosed 2-3 years ago, diabetes; she was prediabetic, heart;cholesterol has been high for about 30 years; since she was in her 30s; all from an unknown date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 02Feb2021 (at the age of 63-years-old) for covid-19 immunization. The patient had no prior vaccination in four weeks. Concomitant medications included rosuvastatin taken for blood cholesterol and takes 20mg once a day prior to stroke and in the hospital they increased it to 40mg once a day and ongoing; ramipril taken for blood pressure and she was prescribed with this medication for a while prior to her stroke. It was discontinued in the hospital. Stated that she did not take it everyday because she was allergic to it; and sitagliptin (JANUVIA [SITAGLIPTIN]) taken for diabetes from an unspecified start date and ongoing and stated that she has been taking for quite a while. On 24Feb2021 she had her second shot. She said that everything was fine that morning; that afternoon her arm was sore. Stated she thought nothing of it. That evening she entertained guest. They were saying she sounded different; they said her speech sounded slurred. She had gotten her vaccine at around 08:00. Again, she didn't think anything about her speech. On 25Feb2021, she got up and did some laundry going up and down the steps. Stated that it was difficult because her arm was still sore. She cleaned the house. At around 15:30 she was doing bills and noticed that her writing looked like a baby's scribble. On 26Feb2021, she noticed that her left arm was weak and was told by her doctor to go to the Emergency Room where they told her she had a stroke. She added that it seemed like her arm was cold for a number of weeks. Stated she was the type to wear t-shirts in the winter because she was always hot. During those weeks she was wearing heavy clothes and was under blankets. She was just now starting to feel more like herself and not so cold all the time. The patient was unable to recall time frame when this symptom began. The events did require a visit to emergency room and physician office. The patient was hospitalized for 4 days due to the events from 26Feb2021 to 01Mar2021. During hospitalization, the patient saw a cardiologist, neurologist, her primary care provider, and the hospitalists who all said it was very suspicious that her stroke happened right after her vaccine. Before she got her second vaccine, she was doing embroidery and everything she normally does; nothing was wrong. They did a CAT Scan that showed nothing. Then the MRI of the brain showed a Pontine Stroke on 26Feb2021. Cardiologist put a heart monitor on her and could not find anything. They were looking for A-Fib or something like that when she was on the heart monitor in the hospital; but it never showed anything irregular. She had a loop recorder implanted to monitor her heart and they haven't found anything wrong on it. She had heart tests, carotid artery tests, ultrasound of her heart and nothing was found on those tests. They pretty much told her in the hospital that they couldn't find a reason for her stroke. She kept asking about the vaccine. They did not rule it out as a cause, but they also did not say it was the cause. All the doctors said they could not pin her stroke on the vaccine. They stated it was suspicious and that they had seen 2-3 other patients with a similar situation. One of the doctor's told her he would not rule it out. They did an ultrasound of her carotids and heart and did not find anything on those tests that would have caused her stroke. She was having lasting effects related to her stroke. Her arm was still sore at times, stated it was a different kind of sore and could be related to all the therapy she does now. The lingering effects after stroke was reported as she was not able to walk at first. She's been doing therapy focused on her left side. Stated that her left side was the dominant side and she cannot write or type. She couldn't do the report online due to the difficulty with typing. She wanted to make sure this was reported. The patient has been doing therapy for 7 weeks, twice a day; and stated she likely still has months more of therapy to try and get her left side back to normal. She said that simple daily duties are difficult. The patient also stated that she was prediabetic before her hospitalization with her number (A1c) usually being 6.5-6.8. She added that when she was in the hospital it was 7.4. She doesn't know what made it go up. Then states she doesn't know if the vaccine made it go up or not. She has a follow up with the neurologist soon. The patient also reported medications she has been taking since her stroke and hospitalization; but not prior to her vaccine which included Amlodipine-Benazepril: 5-20mg once a day and Aspirin: 325mg once a day. The patient stated that stroke and heart problems do not run in her family. The outcome of the events was unknown.
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| 63 | 2021-04-30 | back pain, muscular weakness, limb discomfort |
stomach abdominal cramping; Appetite decreased; like gassiness; back pain; she was so sick.; she has...
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stomach abdominal cramping; Appetite decreased; like gassiness; back pain; she was so sick.; she has a rash about the size of a quarter at the injection site; temperature of 102 degrees/fever; tightness in her chest; She threw up five times; She felt nauseous; Nightmares; She started coughing; muscle weakness; Her arm is sore; She could barley lift her arms; very very weak; delirious; restless; her head was pounding; has been sleeping an enormous amount.; headache; restless; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm right on 12Apr2021 15:00 (Lot Number: EW0153) as single dose for COVID-19 immunisation. Medical history included Neuropathy, Blood pressure abnormal, and allergic to cats, dogs, and everything outside. Concomitant medications included clonazepam taken for neuropathy peripheral, start and stop date were not reported; captopril taken for blood pressure abnormal, start and stop date were not reported; cyanocobalamin (VITAMIN B12) taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 on 23Mar2021 15:40 (Lot number: EH6204, She has difficulty reading the handwriting, she stated that the second character H, may not be an H.) (at age of 63-year-old) in right arm for Covid-19 immunisation and she felt like she got hit by mac truck, she was that tired and She felt like she could hardly move. There was no additional vaccines administered on same date of the Pfizer suspect or prior vaccinations (within 4 weeks). On the weeks that she received the first and second dose of her COVID vaccine, she skipped getting her allergy shot that week. She normally got her allergy shots every week. Patient weight: 176-178 pounds. It was reported that the patient was fine after she received the second dose, until about 11:00PM on 12Apr2021. She started to get muscle weakness. She was delirious on Monday night (12Apr2021). She also felt restless on 12Apr2021. Her head was pounding on 12Apr2021. She felt nauseous on 13Apr2021, very very weak began on 12Apr2021 23:00 and had tightness in her chest on 13Apr2021. She has only thrown up three times in 50 years. She threw up five times on Tuesday, 13Apr2021. She started coughing Tuesday morning, 13Apr2021. She thought maybe she was coughing because she needed to throw up. She does not know why she is coughing. Over the past few days, she has stayed in her pajamas so she did not look for a rash. She noticed she has a rash about the size of a quarter at the injection site. She did not really pay the rash much attention since she was so sick. She has a rash about the size of a quarter at the injection site, She noticed it on 14Apr2021 whenever she took a shower and took of the band aid. Clarified that it is about the size of a silver dollar. There was also a knot. She began running a fever on 13Apr2021. Yesterday (14Apr2021), she had a fever of 102 degrees. She has been taking 2,000-3,000mg of Tylenol and it has not been helping her fever. Yesterday (14Apr2021), her temperature was the same, and her head was pounding. She was able to eat a little bit, she drank a lot. She has been sleeping an enormous amount from 12Apr2021. Last night (14Apr2021) her temperature was at 100 degrees. It started to come down, before she got up. She normally does not sleep eight hours a night. She has been sleeping more than eight hours. Before she got up out of bed this morning (15Apr2021), she checked her temperature and it was 98.6 degrees. She knows that most people do not consider that a fever, but for her that is. Her temperature is usually 97 something degrees. 98.6 degrees is still sick to her. She was going to work from home today (15Apr2021), but whenever she sat at the keyboard to type, she could barley lift her arms. She could barley lift her arms began about 11:00PM on 12Apr2021. She has not tried to work. She still has a bit of a headache, and her fever broke, so she thought she could work today (15Apr2021). She felt extremely weak. Her stomach was cramping. She drank some tea, and ate a banana. She would describe it as stomach abdominal cramping. She was not expecting to feel this way. Her arm was still sore. Her arm was sore began about 11:00PM on 12Apr2021. She was going to see her doctor next week for a semi annual check up appointment.She was restless all day yesterday (14Apr2021). She has a back back, and has back pain. Whenever she has muscle weakness, her back is bad, and makes her hurt every where. Yesterday (14Apr2021), she was still restless and could not sit still. It is better today (15Apr2021), but has not gone away. On the morning of 13Apr2021, she felt nauseous. Now she feels a different type of nauseous. Before the nausea was in her chest, she thought she was going to have a heart at-tack. She called her husband at work, and asked him to come home because she was so scared. Whenever she threw up, it relived the pressure in her chest. She vomited four times and it gave her immediate relief. She vomited one more time later that evening after trying to eat some chicken broth. She just drank liquids after that. Nauseous intestinal: It feels more intense today (15Apr2021). It feels like it is moving down. Clarified that this is the same feeling as stomach abdominal cramping. She has issues with IBS, and diver-ticulitis. But this is different. She has not eating anything. With IBS, it is eating and the diarrhea. This is more like gassiness. She has had bowel movements, they are more intense with abdominal con-tractions. Very weak: Began about 11:00PM on 12Apr2021. She knew that night that she was not going to be able to go to work the next day. It is better. She thought that is was resolved this morning (15Apr2021), but then she could not get up the stairs. Her office is upstairs. Whenever she got to her office, she lifted her her arms to type and it was hard for her to hold her arms up. She has been sleeping an enormous amount: She did not do anything but drink, use the bathroom and sleep on 13Apr2021. Whenever she was sleeping, it was not a good sleep. Her temperature was 102 degrees, and her head was pounding. She was having nightmares. She was in a constant state of dreaming that she could not get out of. She still has been sleeping a lot. She has been trying to walk around. She put on a lidocaine patch, and is wearing a back brace. She was sleeping less than she was but it is still an enormous amount for her. She normally sleeps about five to six hours a night. The events did not result in emergency room visit or physician office visit. Therapeutic measures were taken. The outcome of events muscle weakness, restless, 'Her head was pounding', Weakness, cough, was recovering, of delirious was recovered on 14Apr2021, of 'tightness in her chest' was recovered on 13Apr2021, of nightmares was recovered on 14Apr2021, of other event was unknown.
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| 63 | 2021-04-30 | muscle pain |
she was dying from the first shot; Nausea; right arm got sore; Migraine headache; got chills shaking...
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she was dying from the first shot; Nausea; right arm got sore; Migraine headache; got chills shaking bad; got chills shaking bad; muscle aches, even in her fingers; Feet being Ice cold; no energy; dizzy; This is a spontaneous report from a contactable consumer(patient). A 63-year-old female patient received the first dose of BNT162B2 (Lot Number: ER8737, expiration date: 31Jul2021), via an unspecified route of administration in right arm on 13Apr2021(between 10:15 and 10:30) at single dose for covid-19 immunisation. The patient's medical history included COVID in 2020(had the COVID virus about a week and a half before Christmas/had COVID in the past). Concomitant medications included two unspecified medications. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient was calling about the Pfizer COVID shot. The patient stated she received her 1st shot on Tuesday(13Apr2021) and she didn't know if you have had the COVID virus you weren't suppose to take the shot. She stated that she had the COVID virus about a week and a half before Christmas. The patient stated that she went through a vaccine drive thru and after she got the shot, by time she drove around the corner to park her car, she was dizzy. The patient stated that around 8 o'clock Tuesday night, her right arm was so sore, she stated that she got the shot in her right arm because she uses that arm more. The patient stated her arm got real sore, she had a migraine headache, she got chills and was shaking so bad on 13Apr2021. She had never had chills like that before. Her muscles were aching real bad, it was aching even in her fingers, they were hurting on 13Apr2021. The patient stated that the bottoms of her feet were ice cold on 13Apr2021. She had nausea on an unknown date. She stated that she had the same symptoms as when she had COVID, except the lack of taste and smell. The patient stated that she has no energy on 13Apr2021. She says now, she is afraid to get the second shot because she hears it is worse than the first shot. She stated that still today, she has no energy what so ever. The patient stated she thought she was dying from the first shot on an unknown date. She was scared to take the second one. The patient confirmed she got her 1st dose on 13Apr2021. The patient stated the dizziness started 5 minutes after getting the shot. She said she didn't pay much attention to when it stopped but it was probably later on in the afternoon. The patient said that the dizziness was really noticeable when she was sitting in the car. The patient said her arm is still sore. She said that it is not as sore. She said that on Tuesday it hurt to move her arm but now it is just sore to the touch. The patient stated that her headache, last night started easing off and she woke up this morning and it was gone. The patient stated that the chills and shaking are much better but she still gets cold and then she gets warm and then cold again. The patient stated she took Aleve because her head, and it was easing up before she went to bed, she took Aleve for the pain and headache and she woke up and it was gone. She stated that she is a little better but still doesn't have a lot of energy. The patient stated she was on two medications but it's not for COVID. The patient stated the facility gave her paper work, and she filled out the paper work and she told them that she had COVID in the past on the paper work. No Emergency Room or Physician Office visit was required for the events. The outcome of the events "she was dying from the first shot" and "Nausea" was unknown, of the event " dizzy" was recovered on 13Apr2021, of the event " Migraine headache" was recovered on 15Apr2021, of the event " muscle aches, even in her fingers" and "Feet being Ice cold" was recovered on 14Apr2021, of the other events was recovering.
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| 63 | 2021-04-30 | muscle pain |
Chills; Fever; Muscle soreness; Diarrhea; Nausea; I still have it and I tried to eat, if I eat anyth...
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Chills; Fever; Muscle soreness; Diarrhea; Nausea; I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life; I kept thinking everyday will get better and it's just haven't; Anatomical site of administration-The consumer stated, "On my shoulder, left shoulder."; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left shoulder on 26Feb2021 (Lot Number: EL3247) as single dose (at 63 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included curcuma longa (TURMERIC [CURCUMA LONGA]), colecalciferol (VITAMIN D 3). Previously the patient received the first dose of BNT162B2 (Lot Number: EM9810) on 05Feb2021 in the left shoulder for COVID-19 immunisation. On an unspecified date (as reported), the patient experienced chills, fever, muscle soreness, diarrhea, nausea, I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life, I kept thinking everyday will get better and it's just haven't. Therapeutic measures were taken as a result of diarrhea included antidiarrheal. The outcome of the events was unknown (as reported). The consumer stated, "I had my Pfizer second shot on 26Feb2021 and I had chills and the fever and sore muscles and about four days later I started having Diarrhea, nausea and I had it the entire month and I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life". Anatomical site of administration, the consumer stated, "on my shoulder, left shoulder". No follow-up attempts are needed. No further information is expected.
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| 63 | 2021-05-04 | muscle pain |
Later that night, on 1/27/21, I felt sick, Nausea, muscle soreness. Next day 1/28/21 went to work wi...
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Later that night, on 1/27/21, I felt sick, Nausea, muscle soreness. Next day 1/28/21 went to work with headache, couldn't lift my arm up very swollen. Felt sick got worse felt very hot. Temperature of 104, got sent home from work. Took Acetaminophen and 2 cold tablets fever went down to 101.9. Took cough syrup. Went to sleep. got up next norming arm still very swollen, went to work got sent home no fever but still felt bad, achy muscles and arm still swollen. Stayed home in bed whole weekend. Got headache every day including Monday morning when got up to go to work. Headach on Tuesday also. Felt better on Wednesday. Woke up with headache on Thursday. Woke up with a headache on Friday.
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| 63 | 2021-05-12 | muscular weakness |
PATIENT DEVELOPED FATIGUE, INANITION, WEAKNESS, WORSENED DYSPEA ABOVER HER BASELINE. WAS ADMITTED ...
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PATIENT DEVELOPED FATIGUE, INANITION, WEAKNESS, WORSENED DYSPEA ABOVER HER BASELINE. WAS ADMITTED TO HOSPITAL FROM 5/5/2021 TO 5/10/2021 AND TREATED FOR COPD EXACERBATION AND DESCRIBES SEVERE WEAKNESS SHE SHOULD NOT LIFT UP HER HEAD OR PICK UP HER LEGS. NOW HAS DIFFICULTY WALKING WITH HER LEGS GIVING WAY. EXAM 5/13/2021 SHOWS WEEZES ANTERIORLY , DIFFUSE ECCHYMOSES AT PHLEBOTOMY AND CUFF SIZES AND DIFFUSE HEMOSIDERIN VENOUS STASIS CHANGES LEGS AND 1/2 PT BILATERALLY.
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| 63 | 2021-05-13 | joint pain, back pain |
immune system is obviously compromised; shingles; pain; Rash; Nerve Pain; back ache; hip ache; not f...
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immune system is obviously compromised; shingles; pain; Rash; Nerve Pain; back ache; hip ache; not feeling well; blistering; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration, administered in Arm Left on 07Mar2021 18:00 as 1st dose, single for COVID-19 immunization. The patient has no medical history and concomitant medications. No history of previous vaccinations. No vaccinations in four weeks. On 13Mar2021, 6 days after vaccination, the patient had nerve pain, back ache, hip ache, was not feeling well, and had blistering. The patient went to the urgent care/emergency room because of the back pain and was given Capscian which burned and acyclovir. On 17Mar2021, the patient had pain and rash. The patient's visited a dermatologist due to symptoms and was diagnosed with shingles which developed on the right side of her body on 21Mar2021. The dermatologist changed the acyclovir to valacyclovir at 1 gram three times a day and Triamcinolone Acetonide: ointment Dose: 0.1%, twice a day both starting on 23Mar2021. The patient was also given Lidocaine patch and Biofreeze. Patient states steroid ointment was very amazing and that was just yesterday it was started, already her rash is disappearing, blistering is going away. Dermatologist also said she hadn't been given the right antiviral. The patient requested reassurance that the first dose received would still be effective even though the patient thinks her immune system is obviously compromised (no treatment was reported), says her immune system took away guard for other virus, triggered but not caused it. Maybe just a theory my immune system is working overtime to produce antibodies from having received vaccine and maybe wasn't protecting from dormant chicken pox virus. Patient wanted to make sure the efficacy of first shot is still intact. Patient also stated second dose is scheduled for 29Mar2021 and she was wondering if she would be able to receive the second dose or if she would have to wait a period of time. The outcome of the event immune system is obviously compromised was unknown while for the rest of the events was recovering.
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| 63 | 2021-05-14 | muscular weakness |
Partial loss of vision in left eye after vaccine; muscle weakness; This is a spontaneous report from...
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Partial loss of vision in left eye after vaccine; muscle weakness; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received the first dose (also reported as second dose, pending clarification) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was reported as "ER8730.3ML/M" or "EW0170%ubt2016", pending clarification) via an unspecified route of administration at left arm on 27Mar2021 15:15 (63-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included hypertension, arthritis, pneumonia, and allergies to rosemary, day lollies (day lillies). Concomitant medications in two weeks included verapamil HCl, losartan potassium (COZAAR), chlorthalidone, ubidecarenone (COQ10), and vitamin (unspecified). There was no other vaccine in four weeks. The patient experienced partial loss of vision in left eye after vaccine, muscle weakness on 27Mar2021 16:00. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient did not have COVID-19 prior vaccination. Patient was not tested for COVID-19 post vaccination. Therapeutic measures were taken as a result of the event "partial loss of vision in left eye after vaccine" and included "Optomoligist and referral to retina specialist". The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 63 | 2021-05-18 | joint swelling, joint pain, bone pain |
Extreme acute swelling of distal joint on index finger right hand; Extreme acute swelling of distal ...
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Extreme acute swelling of distal joint on index finger right hand; Extreme acute swelling of distal joint on index finger right hand; Pain in all joints of hands; Pain in all joints of hands; tingling of fingers; aching at prior fracture site; This is a spontaneous report from a contactable physician. A 63-year-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EP7533), via intramuscular route of administration, in right arm on 06Apr2021 09:15 (at the age of 63-year-old) 2nd dose single for covid-19 immunisation. The. Patient medical history was not reported. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19, since the vaccination. Patient drug history was none. The patient received other medications within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (BNT162B2, solution for injection) via intramuscular route of administration in left arm on 16Mar2021 12:00. On an unknown date, the patient experienced extreme acute swelling of distal joint on index finger right hand, Pain in all joints of hand , tingling of fingers , aching at prior fracture site. This case was serious due to disabling or Incapacitating. No treatment was reported. Outcome of the events were not recovered. Additional information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of joint swelling,finger swelling,Arthralgia,paresthesia,bone pain. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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| 64 | 2021-01-03 | limb discomfort |
SHORTLY AFTER VACCINATION, DEVELOPED DIZZINESS, BILATERAL ARMS THAT FEEL "HEAVY". RECEIVED 25MG DIPH...
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SHORTLY AFTER VACCINATION, DEVELOPED DIZZINESS, BILATERAL ARMS THAT FEEL "HEAVY". RECEIVED 25MG DIPHENHYDRDAMINE BY MOUTH. RESOLVED IN ABOUT 1 HOUR
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| 64 | 2021-01-06 | joint pain, muscle pain | fever, chills, headache, muscle and joint pain, duration 24 hours |
| 64 | 2021-01-07 | joint pain |
swelling; Flu like symptoms; low grade fever; headache; joint pain; This is a spontaneous report fro...
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swelling; Flu like symptoms; low grade fever; headache; joint pain; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 64-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) intramuscularly in the left arm on 18Dec2020 at 12:00 am, and the second single dose intramuscularly in the left arm on 04Jan2021 at 12:00 pm (as reported), for COVID-19 vaccination. Medical history included osteoarthritis from an unknown date and unspecified if ongoing. No unknown allergies. Concomitant medication included levothyroxine sodium (SYNTHROID), hydroxychloroquine, progesterone, colecalciferol (VITAMIN D), calcium, magnesium. No other vaccine received in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced flu like symptoms, low grade fever, headache, joint pain and swelling on 05Jan2021 at 01:00 am. The events were non-serious. The patient received paracetamol (TYLENOL) and ibuprofen for the events. The patient was recovering from the events. Information on Lot/batch number has been requested.
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| 64 | 2021-01-09 | musculoskeletal stiffness, muscle tightness |
Patient experience tension and tightness on right upper shoulder / right neck area. Patient receive...
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Patient experience tension and tightness on right upper shoulder / right neck area. Patient received vaccine in the right arm. At 4:40pm, BP 171/93 HR 62 O2=95%. Symptoms are stable. Not worsening. At 4:49pm, BP 153/95 HR 61 O2=95%. Patient clinically stable. Patient still has tension on right shoulder/neck. Patient released from clinic at 4:53pm.
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| 64 | 2021-01-09 | muscle pain |
Violent chills, headache, abdominal pain especially on the right side and vomiting. Muscular aches...
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Violent chills, headache, abdominal pain especially on the right side and vomiting. Muscular aches all over the body. Fatigue. 1/10/21: Still experiencing headache and muscle pain, occasional chills.
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| 64 | 2021-01-10 | neck pain | Headache Neck pain Fever/Chills Nausea/Vomiting Diarrhae |
| 64 | 2021-01-11 | joint pain, muscle pain |
10 hrs after shot uncontrollable shaking & frezzing cold. 5 hrs later really bad muscle pain in hip...
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10 hrs after shot uncontrollable shaking & frezzing cold. 5 hrs later really bad muscle pain in hips & legs. Couldnt stand up. 24hs Later symptoms gone.
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| 64 | 2021-01-11 | joint pain |
Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including finger...
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Difficulty swallowing, fever 102, headache, ears plugged, earaches, all joints ache including fingers, ankles, etc., legs ache, shinbones ache, roots of teeth ache, chills, nauseous, dizzy, delirious, ovaries ache, short of breath, brain fog, not able to multitask, vomiting, sore throat, cough, left arm pain
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| 64 | 2021-01-11 | muscle pain |
Pfizer-BioNTech COVID-19 Vaccine EUA 64-year-old female presents as a rapid response team patient st...
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Pfizer-BioNTech COVID-19 Vaccine EUA 64-year-old female presents as a rapid response team patient status post immunization her second shot was done on Tuesday 2 days ago. She had some diarrhea last night and had some body aches in her arms following the rules today she woke up did not eat breakfast which is not abnormal for her did have some coffee came to work describes some myalgias and felt sweaty felt chilled so she went downstairs had a glass of orange juice to see if that would help had a small helping of hashbrowns did not help she was so she went to employee health in the then was sent here for further evaluation. Patient denies any heart or lung problems high blood pressure diabetes has URI symptoms. No history of PEs or DVTs denies hypertension she fell your blood sugar is low but has no documented history of hypoglycemia is not on any hypoglycemic medications. No history of PEs or DVTs no travel or surgeries. No nausea or vomiting with the diarrhea. Also complains of body aches.BP 120/69 | Pulse 76 | Temp 37 °C (98.6 °F) (Oral) | Resp 21 | Ht 1.676 m (5' 6") | Wt 198 lb (89.8 kg) | SpO2 95% | BMI 31.96 kg/m² Labs reviewed on the chart are normal symptomatically she feels better offered Toradol for myalgias she refused she I suspect is having a reaction/side effect not an allergic reaction to her vaccination she received. Patient discharged.
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| 64 | 2021-01-11 | muscle pain |
at day 18 or 19, post first covid vaccine shot, I began to have many symptoms and did not feel well....
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at day 18 or 19, post first covid vaccine shot, I began to have many symptoms and did not feel well. These were chills, slight fever, no appetite, nausea, muscle aches, fatigue
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| 64 | 2021-01-12 | joint pain |
Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Sev...
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Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe, Systemic: Swollen Hands. Couldn't make fist-Severe; symptoms lasted 4 days
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| 64 | 2021-01-12 | muscular weakness, joint pain |
Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Sev...
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Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe, Systemic: Swollen Hands. Couldn't make fist-Severe; symptoms lasted 4 days.
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| 64 | 2021-01-12 | muscle pain, joint pain | PAIN INJECTION SITE,TIRE,MUSCULAR PAIN,JOINT PAIN,COUGH AND TARDICARDIAC. |
| 64 | 2021-01-12 | muscle pain | Body aches Muscle soreness Chills Fatigue |
| 64 | 2021-01-12 | muscle pain |
Immediately felt "strange" after receiving the vaccination. Developed hypertension, muscle aches, e...
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Immediately felt "strange" after receiving the vaccination. Developed hypertension, muscle aches, extremity swelling.
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| 64 | 2021-01-12 | muscle pain |
Patient reports flu like symptoms, felt very cold and myalgia. Next day she self treated and went to...
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Patient reports flu like symptoms, felt very cold and myalgia. Next day she self treated and went to work and had to leave. Patient reports night sweats, severe fatigue. Patient says the night sweats is the reason she is calling.
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| 64 | 2021-01-13 | joint pain, muscle pain |
Injection site pain; headache; fever 102; chills; muschle & joint pain; face pain; sinus congestion;...
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Injection site pain; headache; fever 102; chills; muschle & joint pain; face pain; sinus congestion; chest tightness by day 3- increased swelling of arm with redness; hot to touch; increased pain radiating to under arm.
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| 64 | 2021-01-13 | musculoskeletal stiffness, joint pain |
45 min after injection face became red and flushed and headache began, redness left in about 4 hour...
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45 min after injection face became red and flushed and headache began, redness left in about 4 hours, headache still remains 24 hours later but mild. joints ache for 24 hours and neck slightly stiff after about 12 hours
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| 64 | 2021-01-14 | joint pain |
Fever 101, chills, Arthralgia, red,hard sore painful left deltoid. Treated with Tylenol, Doxycycline...
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Fever 101, chills, Arthralgia, red,hard sore painful left deltoid. Treated with Tylenol, Doxycycline started on 1/15
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| 64 | 2021-01-14 | back pain |
almost like a thrush in her mouth, white tongue/ believes she had thrush; almost like a thrush in he...
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almost like a thrush in her mouth, white tongue/ believes she had thrush; almost like a thrush in her mouth, white tongue; felt a little cold; legs were sore; headache; Sore arms; severe sore throats; back ache; low grade temp/Low grade fever; coughing; body aches/ whole body was achy; it was sore to swallow; lethargy; This is a spontaneous report from a contactable consumer reporting for self. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Batch/lot number: EL1284, Expiry Apr2021, intramuscularly on 30Dec2020 02:15 (Dose 1), right arm as a single dose (age at vaccination 64 years old) for COVID-19 immunization. Medical history included allergy (usually in the fall she has allergy problems). Her age is considered high risk, works in medical profession (Surgical Tech). Concomitant medication included levocetirizine (Walgreen's generic) 5mg, tablet, by mouth, at night for allergy. The patient had the first dose of the vaccine last 30Dec(2020) and after 2 days (on 01Jan2021) she developed symptoms: Sore arms, severe sore throats, back ache/ back was sore, temperature was up / low grade temp (never high), coughing, body aches. Her back and her legs were sore. Her whole body was achy. It was "like flu-ish kinda." She also had a headache. She started getting the sore throat and headache on 01Jan2021, and she felt a little cold on 02Jan2021. On 02Jan(2021), her first temperature was 100.5 degrees Fahrenheit. She states she had everything except for the GI issues. Around 02Jan(2021) or 03Jan(2021), her symptoms were progressively getting worse. She was told to get COVID tested. There were three exposures since Christmas Eve. So, she went and got a rapid COVID test (04Jan2021) and it came back negative. They also sent out a test that day. She was also tested for Strep (04Jan2021) too because her throat was so sore. It was almost like she had like thrush along with it. She states it was almost like a thrush because she had like a white tongue (onset 03Jan2021). Her throat was so sore, but it was a different kind of sore throat compared to a sore throat she has had before. She explains where the nasopharynx was at the top, it's almost like it was sore from there. It was sore to swallow, it was "a bizarre sore throat." She clarified she noticed the "thrushy" part of her throat around 03Jan2021. The strep test ended up being negative but she believes she had thrush because she was given medication and the medication was clearing that up. However, she still had the symptoms. Because her symptoms only started a few days before, they thought she should maybe wait a couple of days and if she is not feeling any better, she should be retested (for COVID). She went back again yesterday (07Jan2021). She had another Rapid COVID test and also a flu swab and both tests came back negative. She mentions they also did another COVID test (the send out type) and she should get that back around 1pm to find out the results of that. They also did a CBC (07Jan2021) and everything was normal. Her white count was at 7. She was waiting for the 3rd COVID test result today (08Jan2021). She reported that about three days afterwards, she didn't notice the soreness in /her arm. Her throat has improved. Her fever was down to 98 degrees Fahrenheit yesterday (07Jan2021). She states she was feeling better today (08Jan2021). She commented "the lethargy, though." She emptied the dishwasher yesterday (07Jan2021) and had to sit down after emptying it. She states her symptoms have her a little worried. She recovered from the sore arms in Jan2021. The patient was recovering from the severe sore throat, back ache, low grade temp, coughing, body aches/ whole body was achy, believes she had thrush, white tongue, legs were sore, headache, and felt a little cold. The outcome of the event lethargy was not recovered. She was wondering if this was a reaction to the vaccine.
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| 64 | 2021-01-16 | back pain |
I experienced excruciating pain in my middle back--it woke me from my sleep. It felt like that entir...
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I experienced excruciating pain in my middle back--it woke me from my sleep. It felt like that entire area was in pain. I could not been over without twinges of spasms. I could walk without problems--including up and downstairs (with extreme caution). On 1/16/21 I started taking Bayer for Body and Back pain and using Icy Hot on the area that hurt. I called my doctor's office for med for spasms and she said I need to see a doctor. I wanted to be compliant with her recommendations. The doctor suggested Extra Strength Tylenol every three hours.
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| 64 | 2021-01-17 | joint pain |
severe headache; nausea; chills; sinus pain; cough; joint pain; Bedridden; Arm still sore at 60 hour...
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severe headache; nausea; chills; sinus pain; cough; joint pain; Bedridden; Arm still sore at 60 hours; This is a spontaneous report from a contactable other Health Professional (patient). A 64-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), via an unspecified route of administration on 07Jan2021 10:30 at single dose in right arm for covid-19 immunization. Medical history included hypertension (Htn), chronic kidney disease (CKD), the patient had known allergies to ibuprofen, bee stings. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899), on 17Dec2020 at the single dose for covid-19 immunization and experienced very sore arm. Concomitant medications the patient received within 2 weeks of vaccination reported as yes. The patient experienced severe headache, nausea, chills, sinus pain, cough, and joint pain for 24 hrs; headache and nausea continued another 12 hours. Bedridden first 24 hours. Arm still sore at 60 hours on 07Jan2021 22:00. The patient did not receive any treatments. The outcome of the events was recovering.
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| 64 | 2021-01-17 | muscle pain |
Headache, total body muscle aches, chills, slight nausea, fatigue, arm soreness lasting for 3 days. ...
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Headache, total body muscle aches, chills, slight nausea, fatigue, arm soreness lasting for 3 days. tiredness and muscle soreness, intermittent nausea lasted for 5 days
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| 64 | 2021-01-17 | muscle pain |
Extremely sore arm, muscle aches, headache, slight nausea, fatigue. Onset 12 hours after administra...
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Extremely sore arm, muscle aches, headache, slight nausea, fatigue. Onset 12 hours after administration. Effects lasted for 3 days despite round the clock Tylenol dosing.
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| 64 | 2021-01-17 | muscle pain | very sore arm, headache, muscle aches, tiredness, chills |
| 64 | 2021-01-18 | muscle pain |
Pain at injection site; swelling,(size of my palm,); warm to touch, all over body; muscle aches, esp...
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Pain at injection site; swelling,(size of my palm,); warm to touch, all over body; muscle aches, especially shoulder blades; tired/sleepy; tired/sleepy; chills; This is a spontaneous report from a contactable other HCP (patient). This 64-year-old female other HCP reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL128H), via unspecified route at right arm on 08Jan2021 07:45 AM at single dose for COVID-19 immunization. Facility type vaccine was hospital. Medical history included elevated blood pressure and atrial septal defect repair 2008. Concomitant medications included olmesartan medoxomil and hydrochlorothiazide. Historical vaccine included the first dose of BNT162B2 (lot# EH9899) on 18Dec2020 at age of 64 years old for COVID-19 immunization and having arm pain. No Covid prior vaccination. No Covid tested post vaccination. No known allergies. On 08Jan2021 07:00 PM, patient experienced pain at injection site, swelling (size of her palm), warm to touch all over body and muscle aches, especially shoulder blades, very tired/sleepy with chills. No treatment was received. It was reported normal temperature for patient was 97.2 (+) or (-) 98.6. Outcome of events was recovering.
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| 64 | 2021-01-19 | joint pain |
On second day after vaccine-1/8/21-shakes, chills, left arm swollen, bruised, tender, warm, and sore...
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On second day after vaccine-1/8/21-shakes, chills, left arm swollen, bruised, tender, warm, and sore with a knot at injection site. Nausea and fever of 101.8-patient took Zofran=8mg. All over body aches and joint tenderness and soreness. Day 3-1/9/21-extreme fatigue and body aches, no fever or chills. Day 4 and 5 only had headaches, and on Day 6 no symptoms at all.
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| 64 | 2021-01-19 | joint pain |
Fever 101.5, migraine, eyepain, severe arthralgias, nausea and vomiting, weakness, inability tji ...
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Fever 101.5, migraine, eyepain, severe arthralgias, nausea and vomiting, weakness, inability tji think clearly. Residual symptoms at the time of this report
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| 64 | 2021-01-19 | joint swelling |
Experienced swelling in ankles, feet, legs and knees beginning Friday evening 1/15/20. Trying to d...
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Experienced swelling in ankles, feet, legs and knees beginning Friday evening 1/15/20. Trying to determine if this is a covid vaccine reaction. Last dose of nasal spray was Saturday evening, 01/16/20. Since then, swelling is slowly resolving. Reports symptoms to Hospital. Getting Covid tested again today.
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| 64 | 2021-01-19 | muscle pain | FEVERISH; HOT FLASHES; MUSCLE ACHES; MILD HEADACHE; SORE ARM. TOOK ADVIL 600MG 2X DAILY |
| 64 | 2021-01-20 | joint pain, muscle pain | Elevated T of 100.3, body muscle/joint pain; severe headache, nausea, dizziness |
| 64 | 2021-01-21 | muscle pain | chills, skin hurts, headache, nausea, body aches, muscle aches |
| 64 | 2021-01-22 | muscle pain | Chills, fever, headache, muscle pain, fatigue, weakness |
| 64 | 2021-01-23 | muscle pain, joint pain |
I am reporting the following reaction, as I was unable to enter it on V-safe due to the site not fu...
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I am reporting the following reaction, as I was unable to enter it on V-safe due to the site not functioning properly. Twelve hours post vaccination: onset of shaking chills, temperature 101 F, severe headache, nausea, myalgia, arthralgia and fatigue Twenty four hours post vaccination: severe headache and moderate nausea, myalgia, arthralgia and fatigue, temperature 98.8F Forty eight hours post vaccination: moderate headache, mild nausea and fatigue Seventy two hours post vaccination: slight headache, nausea and fatigue Ninety six hours post vaccination: symptoms resolved
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| 64 | 2021-01-25 | arthritis, joint pain |
Has arthritis prior to having the COVID vaccine and after getting it, it went after the over growth ...
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Has arthritis prior to having the COVID vaccine and after getting it, it went after the over growth bones in her hands; She still has a cough and no taste; She still has a cough and no taste; The doctor didn't know what to tell, they said if they were her, they would not take the second shot; Body aches; Chills; Nausea; Tired; Diarrhea; Had a fever reached 100.0; Joint hurt, all of them; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 in Nov2020 (8 weeks ago). Concomitant medications were not reported. After getting the vaccine, she got sick as a dog and couldn't work. She had a fever that reached 100.0, she had body aches. It was explained that she has arthritis prior to having the COVID vaccine and after getting it, it went after the over growth bones in her hands. The caller continues that her joint hurt, all of them, but it was throbbing the most where she has visual arthritis. To sum it up, she had chills, nausea, and body aches the first day. The caller took Tylenol regardless of what the paper said; this was on Friday, 08Jan2021. She kept taking the Tylenol. The next day, she was still tired but when she quit taking the Tylenol on the 2nd day the symptoms returned. It was clarified that she took it in the beginning of the second day twice but at the end of the day wanted to see if she was over it all so she stopped the Tylenol. The symptoms all returned so she took again at bed time, the Tylenol, this was Saturday. On Sunday, she had diarrhea but only a couple times and though it was weird, after that is was over. That day she took Tylenol once. She was calling because she was scared about the second dose, this one produced a big immune response and she says that usually happens with the second dose. The caller wants to know if she should take the second shot, she doesn't want to have this happen again or it be worse. She thought since she had already had COVID it wouldn't be as bad, her immune response. The first dose was given on 07Jan2021. It was explained the only thing unresolved was from when she had COVID, she still has a cough and no taste. There are just few thing she can taste and smell now. The patient said that all the symptoms had resolved as of Monday, the 11Jan2021. Actually, she felt pretty good on the 10Jan2021 so let's say Sunday. She explained that most people get this on the second dose and so if she going have a third response she doesn't want the second dose. She was calling to get an answer to her question, the doctor told her to call to see what could be recommended. She has really good doctors, three of them. The doctor didn't know what to tell, they said if they were her, they would not take the second shot. The patient said she really needs to go. No need to continue when there is no one to tell her if she should take the second shot or not. The patient asked to be contacted via email to relay information about people's immune response to the first dose verses the second dose, is it greater or less. Clinical outcome of the events recovered on 11Jan2021. Information on the Batch/Lot number has been requested.
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| 64 | 2021-01-25 | limb discomfort |
c/o arm tingling after injection, 78-16-114/76 98% RA 1c/o R ear fullness, denies dizziness-A&Ox3, 7...
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c/o arm tingling after injection, 78-16-114/76 98% RA 1c/o R ear fullness, denies dizziness-A&Ox3, 77-18-120/7 ; full ROM noted-provided ginger ale 1016 78-18-112/61-97% RA R arm continues with "hot wire on 1/2 of Right forearm, continues feeling dizzy but not worse, using Zailo patch for pain control x 2 weeks; at 10:22, 74-18-110/59-98% A&Ox3, Right ear fullness/dizziness improving ; at 10:32 71-18-119/63-99% reports decreased ear fullness dizziness, more normal feeling on RFA, full ROM; @ 10:41, 71-18-102/56-98% denies dizziness or arm burning, ear fullness gone, no n/v
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| 64 | 2021-01-27 | joint pain |
Big bruise on right arm; Shoulder and tendons very sore; Shoulder and tendons very sore; This is a s...
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Big bruise on right arm; Shoulder and tendons very sore; Shoulder and tendons very sore; This is a spontaneous report from a contactable healthcare professional (patient). A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date unknown), via an unspecified route of administration in the right arm on 05Jan2021 at 01:30 AM at a single dose for COVID-19 immunization. The patient's medical history included allergies and patient had no COVID prior to vaccination. Patient is not pregnant. The patient's concomitant medications were not reported. The patiently previously received the first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient has not had any other vaccine in four weeks and no other medications in two weeks. On 06Jan2021, the patient experienced big bruise on right arm. It was also reported that shoulder and tendons were very sore. The patient reported that it has been 10 days and it was not getting better. The patient had not been tested for COVID post vaccination. The outcome of the events was not recovered at the time of the report.
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| 64 | 2021-01-27 | arthritis |
Inflammatory pain; Little dizziness/Light headedness; Fatigue; Arthritis pain in hip, in hand and in...
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Inflammatory pain; Little dizziness/Light headedness; Fatigue; Arthritis pain in hip, in hand and in wrist; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as Pfizer's COVID Vaccine; lot number: EL1284; expiration date: 30Apr2021), via an unspecified route of administration left upper arm on Jan2021 at a single dose for covid-19 immunization. Medical history included lupus. There were no concomitant medications. The patient reported that she got her first dose of the COVID Vaccine 2 weeks ago today (Jan2021), and this is her second dose next Saturday. She was a non-medicated, non-kind of remission level of lupus. She mentioned that she was okay the second day, she thinks. She had a little dizziness, fatigue and light headedness that kind of thing. But the top 3 or 4 days ago, so like on her 8th or 9th day, she started to get like inflammatory symptoms like arthritis pain in her hip, in her hand, in her wrist. It was also reported that the patient experienced inflammatory pain on an unspecified date. So, she was just wondering if there are any reports of people with lupus and if the other people have reported that. She mentioned that she wanted to get the second dose but was a little concerned if those arthritis symptoms are going to be worse. No treatment was received. The causality was reported as yes. The patient she hasn't gone visit any emergency room/ physician's office for the adverse events. The outcome of the events was unknown.
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| 64 | 2021-01-27 | muscle pain |
abdominal cramping; Diarrhea; she could hardly walk this morning; muscle ache; arm is a little sore;...
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abdominal cramping; Diarrhea; she could hardly walk this morning; muscle ache; arm is a little sore; nausea; GI problems; This is a spontaneous report from contactable consumer (patient). This 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EL0142), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included ongoing evolocumab (REPATHA, Expiration Date: 04Nov2021), ongoing amlodipine besilate (NORVASC, Strength: 10 mg) as high blood pressure medication, and ongoing amlodipine (Strength: 5 mg) as high blood pressure medication. The patient previously took first dose of BNT162B2 (Lot number: EJ1685) for COVID-19 immunisation. On 12Jan2021, patient got the second dose of the Pfizer COVID vaccine. She did fine all day, but then she started to feel a little nauseous off and on. Then at 4 o'clock before she left for work she developed muscle ache on 12Jan2021. It persisted to the point she could hardly walk this morning (13Jan2021). Patient has not had a fever. She hasn't really had a headache. It has just been muscle aches. Her arm was a little sore on 12Jan2021 but not bad. She has had muscle ache and GI problems with it. She had waves of nausea like she could throw up. She was hydrating really well. The nausea came and went. The muscle aches started at 3:30 to 4 with muscles aching. She got the vaccine to help prevent the spread of COVID and to protect herself as well. Patient experienced abdominal cramping and diarrhoea on 13Jan2021. Outcome of nausea and arm was a little sore was recovering, outcome of muscle ache, abdominal cramping and diarrhea was not recovered, outcome of other events was unknown.
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| 64 | 2021-01-27 | neck pain | Fever, diarrhea. Vomiting, body aches, headache, back of neck aches, pain at site of shot |
| 64 | 2021-01-28 | muscle pain |
headache, bone and muscle aches on left side (collar bone, shoulder blade, rib cage, neck, back), fe...
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headache, bone and muscle aches on left side (collar bone, shoulder blade, rib cage, neck, back), fever (99.5-100.5 for 1+ days), nausea (5+ days)
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| 64 | 2021-01-31 | joint pain, muscle pain |
Severe muscle and tendon pain, chills, moderate headache, chest pressure and pain, trembling, fever ...
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Severe muscle and tendon pain, chills, moderate headache, chest pressure and pain, trembling, fever of 99, fatigue, pronounced pain in arm and shoulders
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| 64 | 2021-01-31 | joint pain |
Fever up to 101.8 before taking Tylenol at 2:30 pm on January 30, 2021. Fever started at 6:30 am tha...
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Fever up to 101.8 before taking Tylenol at 2:30 pm on January 30, 2021. Fever started at 6:30 am that morning. Intense fatigue and moderate headache. I had joint and body aches. I experienced lightheadedness when I got up when fever was 101.8 at 2:30 pm. I had to lay down again and apply a wet towel. Once I felt able to walk (about 10 minutes later) I ate a popsicle and then proceeded to take two 325 mg of Tylenol. Within 30 to 45 minutes fever subsided. I then ate soup, crackers and an orange and drank cranapple juice. I went back to bed and slept some more. I woke up at 5 pm and had a cup of soup, a quarter of an apple and gatorade. At 9 pm I took two more Tylenol to be safe and when to sleep. Sunday I was fine. My arm, never was swollen only a little sore.
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| 64 | 2021-01-31 | muscle pain |
Fever; Muscles started to ache; Headache; Nauseous; doesn't feel good; Arm is sore; This is a sponta...
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Fever; Muscles started to ache; Headache; Nauseous; doesn't feel good; Arm is sore; This is a spontaneous report from a contactable consumer reporting for herself. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were unknown), via an unspecified route of administration, on 11Jan2021, at a single dose for COVID-19 immunization. Medical history and concomitant medications were none. The patient reported that she received her COVID Vaccine on Monday afternoon 11Jan2021. The patient experienced events doesn't feel good and her arm is sore on an unspecified date in Jan2021. On 11Jan2021, after she got the shot, an hour after she started getting nauseous. On Tuesday, 12Jan2021, she experienced headache that went away the next day. On 13Jan2021, her muscles started to ache. That lasted on Wednesday (13Jan2021), Thursday (14Jan2021). On Friday (15Jan2021) afternoon, when she got home from work, she started running a fever and at the time of report she was still running a fever. She stated, "as of right now starting yesterday afternoon, I've got my fever, I don't feel good, I ache, my arm is sore but that's okay. It started Monday afternoon after I got the shot, an hour after I started getting nauseous that was Monday afternoon. Tuesday, I got headache that went away on Wednesday. On Wednesday my muscles started to ache. And that was Wednesday, Thursday and Friday afternoon when I got home from work, I started running a fever and I am still running a fever." When confirmed if the consumer wanted to report the same or looking for some information, consumer stated, "I want to report this and I just want information, what do I do? I test twice a week, rapid test and saliva test for COVID. And I have tested negative for months. And I tested negative before I got the vaccination, I tested on Thursday (14Jan2021), I am still negative. That was the rapid test." The patient took ibuprofen as a corrective treatment for the reported adverse events. Outcome of the event headache was recovered on 13Jan2021, outcome of fever was not recovered, while outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 64 | 2021-02-01 | muscle pain |
tingling in her legs and arms/ tingling in the feet; severe burning in her legs and arms; arm pain; ...
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tingling in her legs and arms/ tingling in the feet; severe burning in her legs and arms; arm pain; headache; myalgias; This is a spontaneous report from a contactable physician. A 64-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included mechanical valve, atrial fibrillation. No known allergies. There was concomitant medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On day 1-3 (13Jan2021), the patient had arm pain, headache, myalgias, then day 4 felt better and on day 5-7 (17Jan2021) developed tingling and severe burning in her legs and arms, that gradually improved to only included tingling in the feet at this date 7 day after injection. No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. Information on the lot/batch number has been requested.
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| 64 | 2021-02-01 | muscle pain |
Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; N...
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Sore arm immediately after getting second dose of COVID Vaccine; Chills; Myalgia; severe headache; Nausea; She felt like she had a temperature and by the time it was checked her temperature was 101.9/febrile; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at left upper arm on 07Jan2021 14:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, not a Military Facility. The patient's medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the Flu Vaccine last part of Sep2020 or Beginning of Oct2020. The patient received the first dose of BNT162B2 (lot number: EK57530), via an unspecified route of administration at left Upper arm on 17Dec2020 9:10AM for covid-19 immunization. She only had a sore arm. It started the same day, a couple of hours after getting the vaccine. It went away a day to a day and a half after it started. After that she was fine. She got the second dose on 07Jan2021. After the second dose, immediately, like within five minutes her arm became very sore, this event was assessed as non-serious by HCP. Also, that Thursday (07Jan2021) night after getting the second dose of the Vaccine around 9PM-10PM she started to get chills, myalgia, severe headache, and nausea. She also mentioned she was so sick during the night she was not able to get up and around. She felt like she had a temperature and by the time it was checked her temperature was 101.9. She was febrile all through 08Jan2021. She started to become afebrile 09Jan2021 with improvement and by 10Jan2021 all her symptoms had gone away and completely resolved. Seriousness Criteria: Stated she felt these are serious. She was unable to go to work on Friday. She could not return back to work until Monday. The HCP assessed all events were related to the vaccine. The outcome of the events was recovered on 10Jan2021. She stated, even though she got so sick with getting the vaccine she was just continuously telling her self this is better than having COVID. She stated she even told people even if she knew after getting the shot she would have this reaction she would still take it. She has seen death occur from COVID and does not want that to happen.; Sender's Comments: Based on plausible temporal relationship, clinical course and known safety profile of the product, the reported events chills, myalgia, severe headache, nausea and fever were likely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 64 | 2021-02-01 | neck pain |
Pfizer-BioNTech COVID-19 Vaccine EUA: Was perfectly fine for the first 10 hrs following injection. T...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Was perfectly fine for the first 10 hrs following injection. Then 11pm Sar night sudden intense pain at inj site spreading rapidly around back of neck and down other arm and up to head. Wracking chills for about 8 hours. Shaking uncontrollably, aches and pains, very weak, exhausted, nauseous. About 8 hours later, 7am Sunday, fever developed, eye pain with severe headache. In bed 30 hours. Monday morning felt much better but still fever @100 and weirdly dizzy. Ate and drank water. Today, almost 72 hours later fever gone, still very dizzy. Drinking water to see if that will help.
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| 64 | 2021-02-02 | joint pain, neck pain |
Symptoms started at 5 PM on February 1, 2021 pain at the injection site then lead to severe headache...
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Symptoms started at 5 PM on February 1, 2021 pain at the injection site then lead to severe headache pain in the neck and shoulders tiredness Fever 100.5Nasal congestion and a dry cough
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| 64 | 2021-02-02 | muscle pain |
faintness; fevers 101.5. Day 3 102.7; myalgia; fatigue; tracheitis; Respiration 40; This is a sponta...
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faintness; fevers 101.5. Day 3 102.7; myalgia; fatigue; tracheitis; Respiration 40; This is a spontaneous report from a contactable physician (patient). A 64-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3426, expiration date: unknown), via an unspecified route of administration on the left arm on 16Jan2021 at 13:30 at a single dose for COVID-19 immunization. Medical history included cardiac hypertrophic cardiomyopathy. The patient has no known allergies. Concomitant medications were not reported. No other vaccine in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on the left arm on 24Dec2020 at the age of 64 years old, lot number: Ek9231. On 16Jan2021 at 11:00 PM, the patient experienced faintness, fevers at 101.5 and 102.7 (on day 3), myalgia, fatigue, tracheitis for 3.5 days- stopped around 4AM on Wednesday, and respiration rate of 40. The patient has no COVID prior vaccination and has not tested for COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 101.5 on 16Jan2021, heart rate (HR): 80 on 16Jan2021, respiration: 40 on 16Jan2021 and body temperature: 102.7 on 20Jan2021. No treatment was administered for the events. The patient recovered from the event tracheitis on 20Jan2021 at 04:00 while recovering from the rest of the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Faint cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-02-02 | muscle pain |
muscle swelling; welts/hives; muscle pain; eyes swelling; tongue swelling; shut throat; blood pressu...
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muscle swelling; welts/hives; muscle pain; eyes swelling; tongue swelling; shut throat; blood pressure elevated; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: eh9899, expiration date not reported), via an unspecified route of administration on 17Dec2020 15:15 at single dose on right arm for COVID-19 immunisation. Medical history included heart disease from an unknown date and unknown if ongoing. No Known allergies to the patient currently. The patient was not pregnant. Concomitant medication in two weeks included Rosuvastatin. The patient received the vaccine in hospital. No other vaccine administered in four weeks. The patient experienced muscle swelling, welts/hives, muscle pain, eyes swelling, shut throat/tongue swelling, and blood pressure elevated hospitalization continued symptoms now for 35 days. All adverse events (AEs) started on 17Dec2020. AEs resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization for two days. Patient received treatment (medications, IV's EKG many test) for AEs. No COVID prior vaccination. Patient did COVID tested post vaccination, COVID test post vaccination included Nasal Swab on 02Jan2021 with result of Negative. The outcome of events was not recovered.
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| 64 | 2021-02-03 | muscle pain |
fever; chills; headache; extreme bodyaches; This is a spontaneous report from a contactable nurse re...
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fever; chills; headache; extreme bodyaches; This is a spontaneous report from a contactable nurse reporting for herself. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 19Jan2021 at 12:30 PM (at the age of 64 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included anemia, hemachromatosis, and penicillin allergy. The patient previously received the first dose of BNT162B2 on 29Dec2020 at 12:15 PM (at the age of 64 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Concomitant medication included epoetin alfa (PROCRIT) and deferasirox (JADENU). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 at 08:00 PM, the patient experienced fever, chills, headache, and extreme bodyaches. The patient did not receive any treatment for these events. The outcome of the events fever, chills, headache, and extreme bodyaches was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 64 | 2021-02-04 | joint pain, muscle pain |
20 mins. after injection itching of face and gradual body. approx. 1 hour throat itching, approx. 4 ...
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20 mins. after injection itching of face and gradual body. approx. 1 hour throat itching, approx. 4 hours mild headache, some rash only on neck and chest but within less than 8 hours full body rash, some milder aches but NEXT morning horrible pain all over like I had been thrown into my worst ever fibromyalgia flair. Complete muscle, joint, entire deep body. WORST i ever had. then a few welps and even though 90% was under the skin rash husband and I could feel the 10 % was red, small pimple like IF not the neck welps and then on the 4 day had a few hives on face only. Worst itching I have ever had and I have had chicken pox and antibiotic rashes. I think the problem has been came off of antibiotic and gradually got ok but can not get this out of system so easy of course. Today is 1 week. rash is better but not gone and itching is some better but still not good. I did not take benadryl or anything since I DO NOT want to interfere with me getting as much benefit from the injection since I now can not have number 2.
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| 64 | 2021-02-04 | joint pain, neck pain | Significant joint pain - neck, arms, hands and legs |
| 64 | 2021-02-04 | joint pain |
Headache; body aches; joint pain; chills; fatigue; This is a spontaneous report from a contactable n...
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Headache; body aches; joint pain; chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el0142), via an unspecified route of administration on left arm on 20Jan2021 at single dose for Covid-19 immunization. The patient medical history was not reported. Concomitant medication included solifenacin succinate (VESICARE), dl-alpha tocopheryl acetate (VITAMIN E), omeprazole and Multivitamin. The patient previously received her firs dose of BNT162B2 at 11:00 AM on 02Jan2021 intramuscularly on left arm for Covid-19 immunization. The patient experienced headache, body aches, joint pain, chills and fatigue on 21Jan2021 05:00 AM. The events were reported as non-serious. The patient did not receive any treatment from events. The outcome of events was not recovered.
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| 64 | 2021-02-04 | joint pain |
Head ache, nausea first day, second day diarrhea, fever, head ache and body aches. Third day injecti...
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Head ache, nausea first day, second day diarrhea, fever, head ache and body aches. Third day injection site red the size of a quarter, hot and sore to the touch and hard. Arm aches into shoulder.
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| 64 | 2021-02-04 | armpit pain, muscle pain |
WAS TOLD THAT MY ARM WOULD BE MORE SORE AFTER THIS SECOND SHOT BECAUSE i CHOSE TO GET IT IN THE SAME...
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WAS TOLD THAT MY ARM WOULD BE MORE SORE AFTER THIS SECOND SHOT BECAUSE i CHOSE TO GET IT IN THE SAME ARM AS THE 1ST DOSE. WHILE I DIDNT FEEL THAT SORE IN MY SHOULDER on 2/3 THE FOLLOWING DAY AFTER A HIGH FEVER AND GENERAL/ALL OVER MUSCLE ACHE, CHILLS my left armpit began to hurt like I'd pinched or been punched in it, today my armpit is swollen with a knot under the skin and very sore to the touch and slightest movement (injection site is red and swollen with a knot in that area as well. *my son also received his second shot on same day & he is reporting to me the exact same issue.* icing the area is not helping.
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| 64 | 2021-02-04 | muscle pain |
Pain in the arm of the injection; muscle pain; fatigue; This is a spontaneous report from a contacta...
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Pain in the arm of the injection; muscle pain; fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3249), via an unspecified route of administration on the right arm on 22Jan2021 08:45 am at single dose for COVID-19 immunisation. Medical history included hyperthyroidism, BP elevation, hyperlipidaemia and allergies to chocolate, coconuts, pineapple, and red dye from an unknown date. Patient previously took codeine, statins, Diflucan, and experienced allergies. Concomitant medication included methimazole, dexlansoprazole (DEXILANT), amlodipine, ezetimibe (ZETIA), evolocumab (REPATHA) from unspecified date and indication. On 22Jan2021 at 08:45 pm, it was reported that the patient experienced pain in the arm of the injection, muscle pain, and fatigue. No treatment was received. The events were considered as non-serious and did not resulted in death, life threatening condition, prolonged hospitalization, disability, and congenital anomaly or birth defect. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since vaccination. No other vaccines were received within the last 4 weeks prior to receiving the COVID-19 vaccination. The patient was reported to be not pregnant at the time of vaccination. The outcome of the events were not recovered.
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| 64 | 2021-02-04 | muscle pain |
Muscular pain in the shoulder, arm and neck through the evening and following day, enough that it li...
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Muscular pain in the shoulder, arm and neck through the evening and following day, enough that it limited my lifting my arm. Further I began feeling extremely itchy on my arms, hands, and face. Checking later in the evening, I did have red blotches all over both arms and shoulders. Took a benadryl and by morning the red blotches were gone as well as the itching.
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| 64 | 2021-02-05 | muscle pain |
I developed a headache, muscle aches and fatigue the day after the vaccine. The symptoms dissipated ...
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I developed a headache, muscle aches and fatigue the day after the vaccine. The symptoms dissipated after Motrin, but kept returning. I tested positive for Covid on 1/2/21.
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| 64 | 2021-02-06 | joint pain |
I made a mistake my vaccine was jan 16th not 15th. That evening i was Very tired got a sore arm an...
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I made a mistake my vaccine was jan 16th not 15th. That evening i was Very tired got a sore arm and fever blister break out on my upper lip 10 hrs after vaccine. Next day Sharp pain in my right big toe joint on day 2, then day 3 burning and stinging pain above my left knee last 6 or 7 hours and also a very sharp pain between my toes like a splinter on the same side as knee pain. I Have felt tired and bad brain fog since vaccine, just have felt really off. Now i am scared to get the second dose. My father had a rare neurological disease after being exposed to chemicals in the army. I then got a cough and had some off color mucous for several days. I am thinking of waiting to get second does, please advise.
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| 64 | 2021-02-06 | muscle pain |
Injection site: Bright Redness 2 inches in diameter, hardness, moderate pain, itching ; malaise; nau...
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Injection site: Bright Redness 2 inches in diameter, hardness, moderate pain, itching ; malaise; nausea; vomiting x 1; headache; chills; low-grade fever; myalgia; fatigue
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| 64 | 2021-02-07 | joint pain, muscle pain |
shaking chills lasting 10 hours; severe frontal headache; nausea; intermittent dizziness; muscle pai...
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shaking chills lasting 10 hours; severe frontal headache; nausea; intermittent dizziness; muscle pain; joint pain; fatigue; This is a spontaneous report from a contactable nurse (patient herself). A 64-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), intramuscular (left arm), on 20Jan2021 09:00, at single dose, for covid-19 immunization. Medical history included allergies: penicillin, sulfa, environmental. Concomitant medications included levothyroxine; cetirizine hydrochloride (ZYRTEC ALLERGY); calcium; and colecalciferol (VIT D3). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), on 30Dec2020 16:00, intramuscular (left arm), for covid-19 immunization at 64-years-old. The patient experienced, "10-11 hr" post injection, on 20Jan2021 20:00 started shaking chills lasting 10 hours. The patient also experienced on 20Jan2021 20:00 severe frontal headache with nausea and intermittent dizziness, muscle pain, joint pain, and fatigue - which all resolved after about 24 hr after onset. No treatment was received for these adverse events. The patient recovered from all the events on 21Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination and have not been COVID tested post vaccination.
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| 64 | 2021-02-07 | joint pain | Headache, chills, fever (102.4), joint pain, fatigue, slight lethargy, lasting 24 hours. |
| 64 | 2021-02-07 | joint pain |
Arm started hurting about 6 hours later. That night she was restless. Temp was 100.7, Took Advil, te...
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Arm started hurting about 6 hours later. That night she was restless. Temp was 100.7, Took Advil, temp came down. The next day, she experienced chills, joint pain, body ache. The next day, still had symptoms but not as bad. She is getting back to normal but is still having some mild symptoms.
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| 64 | 2021-02-10 | musculoskeletal stiffness, neck pain |
Left side of neck stiff with ache, left side of mouth (teeth) ached up to behind the ear. Headache,...
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Left side of neck stiff with ache, left side of mouth (teeth) ached up to behind the ear. Headache, body ache, fatigue, low energy, Ibuprofen 400 mg every 6 hours
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| 64 | 2021-02-11 | back pain |
Severe back pain emanating from spine to left ribs with movement of leg and raising/reaching with ar...
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Severe back pain emanating from spine to left ribs with movement of leg and raising/reaching with arm, rating pain a 10 out of 10. I grimaced out loud with any movement. It felt like a vise grip that would break my back apart. Initially, it began as slight pain at 8 am as I was working at my desk. The pain increased in intensity, duration and occurrence over the next 10 hours. I tried several remedies at home. First, I took a 10 mg cyclobenzaprine tablet and laid down for 2 hours from 11:30 am - 1:30 pm. At 2pm, I used 1%voltaren gel on my back. At 3pm, my husband (a retired pharmacist) gave me 600 mg of ibuprofen and I applied ice pack to my back. At 4 pm, I took 5 mg prednisone. At 7 pm, I took 600 mg ibuprofen.
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| 64 | 2021-02-13 | joint pain, back pain |
2/1 woke up with severe/stabbing upper right back/scapular pain. took NSAIDs and comfort measures. ...
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2/1 woke up with severe/stabbing upper right back/scapular pain. took NSAIDs and comfort measures. Had an X-ray. 2/7 developed a rash in the same area in a line.
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| 64 | 2021-02-14 | joint pain, muscle pain, neck pain |
fast heartbeat, dizziness and weakness, excessive fatigue/tiredness, chills, joint and muscle pain, ...
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fast heartbeat, dizziness and weakness, excessive fatigue/tiredness, chills, joint and muscle pain, back of the neck/headaches and pain, disoriented, injection site swelling, tenderness, and hot to the touch, fever, sinus infection like symptoms ( stuffiness, difficulty breathing, ear pain, sinus/facial pain )
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| 64 | 2021-02-14 | back pain | Back pain |
| 64 | 2021-02-14 | joint swelling, joint pain |
extreme swelling and severe pain in both wrists/ hands starting 2/7/21.seen in urgent care 2/8/21 an...
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extreme swelling and severe pain in both wrists/ hands starting 2/7/21.seen in urgent care 2/8/21 and admitted through ER on 2/10/21. Inpatient for 3 days. IV antibiotic DC'd when blood cultures negative. Ultrasound left arm negative for DVT. Seen by Infectious Disease and he felt it was due to covid vaccine reaction. Started on steroid
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| 64 | 2021-02-15 | joint pain |
During the early morning hours within 12 hours of the vaccine I woke up to extreme pain in my right ...
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During the early morning hours within 12 hours of the vaccine I woke up to extreme pain in my right shoulder joint. Any movement hurt intensely. As the day went on I took acetaminophen which substantially decreased the pain of movement. I did that twice during the waking hours the first day after the vaccine. Within 2 days the pain was gone.
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| 64 | 2021-02-15 | musculoskeletal pain |
At 6:30 p.m. I began with palpitations of heart, lasted about 90 minutes. The palpitations were in...
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At 6:30 p.m. I began with palpitations of heart, lasted about 90 minutes. The palpitations were intermittent. The night and next day I had musculoskeletal pains, and tiredness. The primary thing I would like to report is that starting on Saturday, Feb. 13th around 8 pm, I began with a cold sore, or fever blister of upper lip. Over the course of the next 24-36 hours, I developed at least 4 more fever blisters. I am not prone to fever blisters, and have never in my life had more than one, infrequently. They are on upper and lower lip, and one is even immediately below my lip, on my skin that is not mouth mucosa. They are painful .
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| 64 | 2021-02-17 | limb discomfort, musculoskeletal discomfort |
Immediately on the day of the vaccine and on the day after the vaccine, I had periods when I felt a...
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Immediately on the day of the vaccine and on the day after the vaccine, I had periods when I felt a little lightheaded but otherwise felt fine except for a little injection site discomfort. Two days after the vaccine I began to feel back and right leg discomfort. By Day 3, the pain in my leg was severe and I started to notice the tell tale signs of Shingles. I immediately contacted my PCP and the shingles diagnosis was given on 2/8/21 due to my symptoms and appearance of my leg. I was immediately put on a 7 day course of Valtrex. On 2/9/21, because the pain was intolerable, I contacted my primary care physician ad was given a 50 mg dose of Lyrica to be taken twice a day.On 2/10/21 the lyrica was increased to 75 Mg dose twice a day since the 50 mg wasn't totally helping. On 2/12/21 the lyrica was ordered for 3 more days and just to be sure there wasn't a herniated disk causing any of the pain, am xray of the thorasic spine was ordered. On 2/17/21, I had an appointment with a pain management physician. He examined me and performed a neurological check and checked the function of my back and confirmed the shingles diagnosis. He continued the Lyrica for 3 months and ordered a Medrol 5 day dose pack. His follow up is in 3 months. He told me not to take Dose 2 of the Covid Vaccine.
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| 64 | 2021-02-18 | muscle pain |
3 weeks after the first dose I developed sudden onset severe myalgias in the cervical neck, shoulde...
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3 weeks after the first dose I developed sudden onset severe myalgias in the cervical neck, shoulders, deltoid, gluteal, and hamstring muscles. These were my only symptoms at onset. No fever, No Sand S of infection, etc. VItals were stable. Lab work, including complete chemistries CBCD, ESR, and CRP, was all WNL. However, 5 days after onset with no improvement in the myalgias, my creatinine kinase (CK)was 402 ( normal up to 175). Over a period of an additional 8 days, the myalgias have gradually decreased, and my current CK level, as of 2/17, is 275. My physician is terming it autoimmune myositis and believes it is from the vaccine. I have also had some mild tingling in my hands and feet intermittently that started soon after the myalgias. No true neurological deficits. No other symptoms. I am the patient but also a docotrally prepared nurse practitioner, so that is why this patient report is in medical terminology.
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| 64 | 2021-02-19 | muscle pain |
extreme muscle pain (first 24 Hours) severe headache (first 24 Hours) Dull headache (Second and Thir...
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extreme muscle pain (first 24 Hours) severe headache (first 24 Hours) Dull headache (Second and Third day) Fatigue (every day) Nausea (first 24 Hours) Dizziness (every day) Took Tylenol on first day, later in the evening, and It really helped
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| 64 | 2021-02-21 | musculoskeletal stiffness |
Patient complained of stiffness/right side; headache, dizziness after receiving first dose of Pfizer...
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Patient complained of stiffness/right side; headache, dizziness after receiving first dose of Pfizer; Comprehensive nursing assessment done including vital signs, pain, neurological status. Patient stated she had no difficulty swallowing. She was given water. Vital signs remained stable.
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| 64 | 2021-02-21 | neck pain, joint pain |
Patient received vaccine 17Feb21. Within 24hrs pt developed radiating pain from shoulder to neck tha...
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Patient received vaccine 17Feb21. Within 24hrs pt developed radiating pain from shoulder to neck that has lasted since today, 22Feb. Of note pt recently had back surgery on 30Nov20 which she states is contributing to her pain.
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| 64 | 2021-02-22 | muscle pain | Fatigue, muscle aches, chills, fever, nausea, diahrea, vomiting |
| 64 | 2021-02-22 | neck pain |
I had my 2nd dose of covid vaccine on 1/15, around 5 pm. Next day when I got up about 7:20 I felt d...
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I had my 2nd dose of covid vaccine on 1/15, around 5 pm. Next day when I got up about 7:20 I felt dizzy nausea and wanted to vomit. Then I passed out, I fell down and hit my face on the floor. My family called 911 paramedica. They ,measured d my blood pressure and it was too low. The area around my right eyebrow was swollen and my neck hurt as precaution I went to the hospital. I suspect the incident and its symptom are side effects of the vaccine given the timing. Later on I had headache off and on and brain fog.
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| 64 | 2021-02-24 | neck pain |
Radiating sharp pain that started in neck, then went to L of chest to L upper arm. Evaluated by EMS...
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Radiating sharp pain that started in neck, then went to L of chest to L upper arm. Evaluated by EMS, cleared.
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| 64 | 2021-02-25 | joint pain | RASH, DYSPNEA, CHEST PAIN, FEVER JOINT PAIN, CHILLS, FEVER. TREATMENT: KENALOG, BENADRYL, PEPCID. |
| 64 | 2021-02-26 | muscle tightness |
Face flushed, head felt full. Other than that nothing until we started home. Upper lip began to it...
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Face flushed, head felt full. Other than that nothing until we started home. Upper lip began to itch a little. A little itching around eyes. About an hour after, felt tightness in my throat and neck, glands felt swollen. Became slightly hoarse, had to clear my throat often. Felt a little like asthma attack. Have had similar reaction when eating seafood
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| 64 | 2021-02-27 | neck pain |
Site pain transferred to neck and down arm 2/25 6:00 pm lethargy; 7:00pm 2/25 8:30 low grade fever; ...
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Site pain transferred to neck and down arm 2/25 6:00 pm lethargy; 7:00pm 2/25 8:30 low grade fever; exhaustion 2/26 extreme fatigue; 2/27 extreme fatigue; nausea; diarrhea; headache
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| 64 | 2021-02-28 | joint pain |
Sweating, nausea, dizziness, aching joints. Effects seem to come in waves, sometimes feeling ok, an...
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Sweating, nausea, dizziness, aching joints. Effects seem to come in waves, sometimes feeling ok, and then completely down for a couple of hours, ending by day 3. Have been constipated for five days now, with no bowel movement since vaccine. I have had extreme insomnia since vaccine.
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| 64 | 2021-02-28 | back pain, joint pain |
Moderate to severe pain in arm, shoulder, back started about one hour after shot. Lasted until next ...
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Moderate to severe pain in arm, shoulder, back started about one hour after shot. Lasted until next morning. No medication taken. Moderate headache lasting through next morning, general grumpiness for 2 days, brain fog beginning following morning - forgetfulness, depression. Still continued through today (Monday, March 1, 2021). Symptoms are not severe, but are acute enough that they are impacting quality of life.
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| 64 | 2021-02-28 | muscle pain, joint pain |
Chills; headache; muscle and joint pain; muscle and joint pain; tiredness; nausea; Like a mild flu; ...
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Chills; headache; muscle and joint pain; muscle and joint pain; tiredness; nausea; Like a mild flu; This is a spontaneous report from a contactable other healthcare professional (patient). A 64-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL 8982, expiry date: not reported), via an unspecified route of administration, on 26Jan2021 12:15 PM at a single dose on the right arm for COVID-19 immunization. The patient did not receive any other vaccine in four weeks prior to receiving bnt162b2. The patient was not pregnant. She was not diagnosed with covid prior to vaccination. Medical history included high bp (blood pressure) and type 2 diabetes. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL 1284, expiry date: not reported), on 05Jan2021 10:30 AM on the right arm for COVID-19 immunization (at the age of 64-year-old). On 26Jan2021 04:30 PM, the patient experienced chills, headache, muscle and joint pain, tiredness, nausea; like a mild flu. No treatment was received for the events. Outcome of the events was recovering. The patient was not tested for covid post vaccination. No follow up attempts are possible. No further information is expected.
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| 64 | 2021-03-03 | limb discomfort |
Tightness in left bicep (frontnot where shot administered) and forearm and tingling in hand (left ...
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Tightness in left bicep (frontnot where shot administered) and forearm and tingling in hand (left side where shot administered. Tightness has dissipated somewhat, but tingling in hand continues to be present Sore throat right after administration Extremely sore arm for 2 days after administration
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| 64 | 2021-03-04 | muscle pain, joint pain |
I had severe COVID and was hospitalized on Dec 7, I was in hospital (non ICU setting) for 5 days an...
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I had severe COVID and was hospitalized on Dec 7, I was in hospital (non ICU setting) for 5 days and had O2, remdisiver and dethemethzone IV. I recovered fully, and have felt very good since mid January. My reaction after my 1st dose of vaccine on Feb 25 started 20 hours after shot. Worsened through the day and I got sicker at 24-36 hours, and then stayed in bed another day. Symptoms were identical to my bout with COVID: chills (no fever), nausea, aches in joints and muscles, fatigue. They were quite significant==I could not be out of bed. As it went along I also developed the feeling in my chest like COVID--tough to take deep breath, chest hurt---but my O2 readings were fine. Recovered after 48 hours, People who have had COVID should be aware that they will have a significant response to the vaccine on the 1st does. I am questioning having a second dose I have not reported this to my doctor
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| 64 | 2021-03-05 | limb discomfort |
Patient received vaccine at 11:25 am. History of reaction to tetanus in past. Patient stayed to be o...
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Patient received vaccine at 11:25 am. History of reaction to tetanus in past. Patient stayed to be observed for 30 minutes. At approximately 11:40 am, patient c/o GI-upset; continued to observe. At approximately 11:50 am patient c/o left arm heaviness and numbness to fingers and pain up and down left arm. Paramedics were radioed at 11:53 am and arrived at 11:55 am to assess patient. Patient left with daughter in stable condition at 12:15 pm.
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| 64 | 2021-03-07 | joint pain |
My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling u...
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My arm hurt so badly that I couldn't lift it or sleep tiredness headache chills joint pain feeling unwell difficulty breathing a fast heartbeat weakness
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| 64 | 2021-03-07 | muscle pain |
Huge headache, high fever 103,and chills for two days then lowgrade for 36 hours, dizziness,severe m...
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Huge headache, high fever 103,and chills for two days then lowgrade for 36 hours, dizziness,severe muscle pains, extraordinary fatigue, diarrhea and nausea, swelling feet, weakness
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| 64 | 2021-03-07 | muscle pain |
Muscle soreness of bilateral legs and hip joints/ got worse; pelvic pain; Couldn't walk; Drag showed...
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Muscle soreness of bilateral legs and hip joints/ got worse; pelvic pain; Couldn't walk; Drag showed inflamed pelvic girdle; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. Solution for injection, lot number: 42 (as reported)), via an unspecified route of administration on the right arm on 15Jan2021 08:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included metoprolol, fish oil, calcium and monascus purpureus (RED YEAST RICE). The patient had known allergies: DILAUDID. The patient experienced muscle soreness of bilateral legs and hip joints on 22Jan2021 and it got worse. Patient also experienced deep pelvic pain on an unspecified date in Jan2021 and went to physician on 24Jan2021. The patient couldn't walk in Jan2021. Cat scan showed no apparent reason, drag showed inflamed pelvic girdle on Jan2021. The outcome of the events was not recovered.; Sender's Comments: Case serious due to Pelvic inflammatory disease, classified Medically Significant and always serious event, per List Critical Term. Other reported events were non-serious. Based on available information, the Company considered that all reported events were possibly associated to BNT162B2 injection, due to a plausible chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-03-08 | joint pain, neck pain, back pain | Pain in neck, base of scull, shoulder and back on right side one week later for 2 to three days. |
| 64 | 2021-03-08 | muscle pain | Fever of 100 degrees, pain at injection site, fatigue, muscle aches, difficulty breathing |
| 64 | 2021-03-08 | neck pain, limb discomfort |
One and a half hours after the vaccine, I suddenly became very dizzy and had a hard time focusing. ...
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One and a half hours after the vaccine, I suddenly became very dizzy and had a hard time focusing. I was extremely happy that I was NOT driving. I could not think straight and had sweat pouring down my face. My head was very heavy and as the day progressed, my neck also became sore. I took Advil and later Tylenol and they helped the head ache but not the dizziness. I lost appetite. I consulted the reading material about the vaccine and all of my symptoms were normal side effects, so I did not seek medical assistance. My daughter is a doctor and wanted me to report for statistical reasons.
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| 64 | 2021-03-09 | muscle pain |
pt. had a potential COVID exposure at work prior to getting the COVID vaccine, she is experiencing s...
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pt. had a potential COVID exposure at work prior to getting the COVID vaccine, she is experiencing symptoms of vomiting, headache, muscle aches. I recommend you get tested for COVID just to rule out whether you have COVID or not, if test comes back positive you would have to wait till the symptoms subside prior to getting your second dose.
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| 64 | 2021-03-09 | neck pain |
Dizziness/light-headed, feeling like I was about to faint started morning after vaccine along with s...
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Dizziness/light-headed, feeling like I was about to faint started morning after vaccine along with severe neck pain. Possible intermittent fever. Dizziness continued for 2 days. Neck pain improved somewhat but is still bothering me, woke me up at night. Now a week later and my neck still hurts. I called my primary care office on March 3 and they said call 211. That made no sense so I asked again and they finally said I could see a nurse practitioner the next day. However I didn?t go because I couldn?t drive. I am a little worried about the second dose.
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| 64 | 2021-03-10 | armpit pain |
Sore injection site, fatigue, low grade fever, sore armpit ( radiating to left breast ). Fatigue. A...
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Sore injection site, fatigue, low grade fever, sore armpit ( radiating to left breast ). Fatigue. And Temperature lasted approximately 24 hours. Pain in at injection site and armpit pain lasted 3 days.
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| 64 | 2021-03-10 | back pain |
Woke up with moderate pain in coccyx lower back area. Applied heat, essential oil applied. Pain is i...
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Woke up with moderate pain in coccyx lower back area. Applied heat, essential oil applied. Pain is intermittent still, today took Tylenol.
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| 64 | 2021-03-10 | muscular weakness |
Pain and weakness in my right arm. Inability to lift things above shoulder height. Pain when tryin...
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Pain and weakness in my right arm. Inability to lift things above shoulder height. Pain when trying to sleep at night. Pain when trying to do certain things at my job with my right arm.
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| 64 | 2021-03-11 | joint pain |
64 yo female with hx bipolar disorder on multiple psych meds, Htn, here for same day visit. Pt repor...
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64 yo female with hx bipolar disorder on multiple psych meds, Htn, here for same day visit. Pt reports got her second covid vaccine on 3/92021 in the left arm, Pfizer. Yesterday (3/10/21) woke up with severe right knee pain, felt like she could not bear weight/ws going to fall. She went to son's apartment who is in same building and then went to lie down in bedroom. Because she drinks a lot of water, she had to get up to go to bathroom to urinate. She was about to sit down on toilet, when she felt both her legs go numb as well as her arms and her vision was blurred. She tried to grab the tub but fell forward on the floor. She states she urinated on the floor. She was on the floor for about 30 mins until her son got her up and back to bed. Later in the day she needed to urinate again and when she got up, she felt unsteady and fell on the bureau bruising the left arm. Since she feels a bit unsteady with gait and used a walker to come hre today. She denies feeling dizzy before her falls. She denies striking her head. She denies convulsions or hx of seizure disorder. She reports no new meds, only recent change an increase in her alprazolam dose. She does report a headache day after her vaccine.'She denies vomiting or diarrhea or antecedent illness. No longer has headache. She denies positional changes Of note she is on propranolol (prescribed by psych) as well as lisinopril-hydrochlorothiazide for HTN 64 yo female with bipolar disorder on multiple psych meds, htn on propranolol 20 mg bid and lisinopril-hydrochlorothiazide, s/p recent Pfizer covid vaccine, s/p presyncope episode after experiencing severe right knee pain and attempted micturition. Pt felt like her sight was affected and experienced numbness/weakness in legs and arms causing a fall. Did not hit head. The history is most suggestive of a vagovagal episode.
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| 64 | 2021-03-11 | joint pain |
Woke at 32hrs with severe pain in Rt hip joint and Rt knee joint. later in day rt leg was numb, unab...
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Woke at 32hrs with severe pain in Rt hip joint and Rt knee joint. later in day rt leg was numb, unable to bear weight, go up stairs without assist or sleep. Next day #3, severe pain in Rt hip, Rt knee and femur. Not responding to Motrin 800mg Q6-8hrs, Tylenol 1gm Q6-8 hours. Day #4 pain now radiating down rt leg through both joints and into Rt calf. Now Monday- called PCP, advised symptoms and would be starting perocets for 2 days of severe pain post vaccine. Also took ASA 325mg for blood clot risk know with virus even through pain was hip to ankle now (not ascending but descending) Percocet Q6hours without improvement but could sit and sleep with pain (dulled brain response to pain). Day #5- leg completely numb, pain now following sciatic nerve, stopped meds as no improvement and developed headaches, stomach aches and constipation from meds. Day#6 Pain severe in am, from hip to ankle- leg and heal of Rt foot numb. Today #7 pain on awaking, Rt hip all along sciatic nerve to foot which remains numb in heel.
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| 64 | 2021-03-11 | bone pain, muscle pain |
the day after my shot i had chest pain that felt like my bones needed to pop and the pectoral muscl...
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the day after my shot i had chest pain that felt like my bones needed to pop and the pectoral muscles were extremely sore and had a hard time lifting both arms due to the pain. Took tylenol and it did not help at all. The intense pain lasted that day and did ease up somewhat the following day but was still sore with a dull achy pain, and today is the 3rd day and still just a little sore in the chest area
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| 64 | 2021-03-11 | muscular weakness, joint pain |
Pfizer injection Jan 26, 2021 First symptoms 4-5 days after: "unsettled" feelings, disturbed sleep, ...
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Pfizer injection Jan 26, 2021 First symptoms 4-5 days after: "unsettled" feelings, disturbed sleep, general "dumpiness" ~9 days after: Tender joints in toes, leg pain and weakness, dry, irritated, blurry eyes, brain issues: dizzy, word retrieval issues, derealizing Feb 11: fatigue, muscle weakness and pain in legs Feg 12: headache, heavy feeling in chest, continuing leg pain and weakness. March 12 Pain in legs persists, but improved, brain issues improving, but not resolved, eyes still somewhat dry and blurry/strained
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| 64 | 2021-03-11 | muscle pain | Fever & chills, muscle aches all over body, fatigue (slept a lot). |
| 64 | 2021-03-12 | joint pain |
Nausea, diarrhea, pounding headache, fever (101.6), extreme fatigue, sore joints, aches, loss of app...
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Nausea, diarrhea, pounding headache, fever (101.6), extreme fatigue, sore joints, aches, loss of appetite (3 days)....
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| 64 | 2021-03-12 | musculoskeletal stiffness | Bad headache, pain and muscle stiffness at injection site |
| 64 | 2021-03-12 | muscle pain | Chills, headache muscle aches all over, coughing, nausea. |
| 64 | 2021-03-14 | joint pain |
Fever, chills, headache, extreme joint pain. Lasted six hours until I took Tylenol. I took Tylenol ...
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Fever, chills, headache, extreme joint pain. Lasted six hours until I took Tylenol. I took Tylenol every six hours for 24 hours, was very tired with body and joint aches.
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| 64 | 2021-03-14 | neck pain |
had flush feeling (much like injection during CT scan); Within hour my ears felt hot and turned brig...
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had flush feeling (much like injection during CT scan); Within hour my ears felt hot and turned bright red Subsided within hour.; Ate supper, Went to bed, upon waking in nite experienced imbalance; vertigo; Neck pain; headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female non-pregnant patient received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264, Solution for injection), via an unspecified route of administration in the left arm on 29Jan2021 (at the age of 64-years-old) as a single dose for COVID-19 vaccination. Medical history included CAD (coronary artery disease), Irregular heart rhythm, BPPV, degenerative disc disease, anxiety, ptsd (post-traumatic stress disorder), pre diabetic, Allergies to food, chemical and sensitivities and med and sensitivites. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. Upon receiving injection, on 30Jan2021, patient had flush feeling (much like injection during CT scan). Within hour her ears felt hot and turned bright red Subsided within hour. After supper, went to bed, upon waking in night experienced imbalance. Laying back down experieced vertigo (what she thought was a BPPV episode, a prior cond) but she couldnt figure out which side to treat, she performed maneuver. But did not resolve. She was remaining off balance and spinny even being upright with movement of head or eyes. Neck pain and headache residual nausea. About 12 hours after injection. Upside, her arm doesnt hurt. The patient did not receive any treatment for the events. No seriousness criteria was reported. The patient underwent lab tests and procedures which included computerised tomogram and results are unknown. The outcome of events was unknown.
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| 64 | 2021-03-15 | armpit pain |
#1 Metal taste in mouth since 30 minutes after injection #2 Pain under left arm pit. Upon inspectio...
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#1 Metal taste in mouth since 30 minutes after injection #2 Pain under left arm pit. Upon inspection felt a lump and swelling. Assume it is lymph node swelling.
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| 64 | 2021-03-15 | muscle pain, armpit pain |
Within hours mild mental fog and fatigue. Intense fatigue leading to bed rest last four days accompa...
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Within hours mild mental fog and fatigue. Intense fatigue leading to bed rest last four days accompanied by mild mental fog, myalgia, intermittent low grade fever and marked depressed mood. Severe left breast pain and left axilla pain on the third day severe enough to wake from sleep. Lasted about 48 hours.
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| 64 | 2021-03-16 | armpit pain | Redness, swelling, bruising at injection site, pain in armpit lymph glands, chills & body ache |
| 64 | 2021-03-16 | neck pain |
Approximately 2 hours post vaccine I noticed my scalp feeling hot, tight, and tingly in the bilatera...
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Approximately 2 hours post vaccine I noticed my scalp feeling hot, tight, and tingly in the bilateral occipital area. Some neck pain and traveling from neck to scalp. Today is 3/17/21 and the symptoms are still present but somewhat improved over the last week. The sensations are now mostly on the R side. I took Advil 400mg TID for 2 days and also applied a heating pad to the neck and back of head. I saw my PCP today as this is causing me a lot of anxiety, she prescribed Prednisone 40mg daily X 3 days.
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| 64 | 2021-03-17 | joint pain |
1. Heart palpatations - didn't last long - seemed to subside after I drank water and did deep breat...
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1. Heart palpatations - didn't last long - seemed to subside after I drank water and did deep breathing 2. Woke next morning with pain between my shoulder blades - didn't last long either once I was up and moving
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| 64 | 2021-03-17 | muscular weakness |
Today marks 2 weeks since my shot and my right arm is as sore as it was on day one. It?s primarily ...
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Today marks 2 weeks since my shot and my right arm is as sore as it was on day one. It?s primarily in the right bicep I feel like muscle is getting weak. I have iced it and taken Advil and Tylenol. Nothing takes the pain away. Additionally the pain wakes me up from sleep.
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| 64 | 2021-03-18 | joint pain, muscle pain |
Most severe headache ever Fever and chills Extreme fatigue Nausea and Vomitting 10xs Joint and muscl...
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Most severe headache ever Fever and chills Extreme fatigue Nausea and Vomitting 10xs Joint and muscle ache
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| 64 | 2021-03-18 | joint pain | Joint pain and fatigue. |
| 64 | 2021-03-18 | back pain, armpit pain |
Current: Severe pain and swelling in left armpit; feels as if it is cut open. Swelling is visible, a...
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Current: Severe pain and swelling in left armpit; feels as if it is cut open. Swelling is visible, and armpit is hard and hot to the touch. Yesterday (resolved): fever of 102, profound chills, skin was painful all over, mild headache and low backache, exhaustion.
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| 64 | 2021-03-18 | back pain |
This was my second COVID vaccine. At 23.5 hours since the shot every joint in my body lit up and my...
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This was my second COVID vaccine. At 23.5 hours since the shot every joint in my body lit up and my whole body felt like dead weight. I started coughing as well. I left work, went straight home and was in bed by 5:00PM. I slept all night, got up @ 4:30 AM and went to work. I felt 100% better. Just my shoulders kind of ached and my back was achy but that has mostly subsided by 11:00 AM today.
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| 64 | 2021-03-18 | muscle pain |
Flushed face, burning and tingling, tight. Started within 8 minutes of injection. 30 minutes later i...
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Flushed face, burning and tingling, tight. Started within 8 minutes of injection. 30 minutes later it spread to back of the neck and went up through the scalp at the back of the head to the crown of the head. Headache the whole time. Face returned to normal in 90 minutes. Scalp in 2 1/2 hours. Muscles aches starting in left arm, moved to left leg and then to right leg. Headache is persistent but mild 4 hours later.
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| 64 | 2021-03-19 | joint pain |
intermittent pain and burning in elbow, Right side > left side. Started off as occasional and local...
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intermittent pain and burning in elbow, Right side > left side. Started off as occasional and localized to one spot, now getting worse on right arm.
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| 64 | 2021-03-19 | muscle tightness |
Almost immediately I felt a tightening on the back of my neck. It was familiar to me; I feel exactl...
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Almost immediately I felt a tightening on the back of my neck. It was familiar to me; I feel exactly that same symptom when I eat something with MSG. Within minutes I felt light headed and exhausted. I went to the pharmacist and he gave me Benadryl; I don't know the exact amount, but it was in the small cup that comes with different kinds of meds. It made no difference, so I had to call my husband to pick me up. I was very, very tired so I slept for the next 3 hours. I went back to bed 2 hours later and slept through the night. I was up the next day and by 11 am was very tired; I slept for 4 hours, then again through the night. By the next day, I felt normal.
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| 64 | 2021-03-19 | muscle pain |
Muscle soreness through the shoulders right to left. Occasional tightness through my eyes, fatigue. ...
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Muscle soreness through the shoulders right to left. Occasional tightness through my eyes, fatigue. Muscle soreness and fatigue lasted 2 days. The vision/ headache tightness was very subtle almost not worth mention.
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| 64 | 2021-03-19 | muscle pain | Dizzy, headache, weak, sore arm, sore muscles very tired |
| 64 | 2021-03-20 | armpit pain |
Headache and stuffy head night of vaccine. took Tylenol Next morning--Left armpit sore/tender--coul...
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Headache and stuffy head night of vaccine. took Tylenol Next morning--Left armpit sore/tender--could see swelling in armpit and feel lump. by evening could feel pain down into left breast. following morning--could see little "lumps"/swollen areas on left side of left breast. Armpit still swollen and sore
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| 64 | 2021-03-20 | back pain |
3/18/2021 9:00am Vaccine administered Around 2:00 pm Chills and stomach pain Around 3:00 pm 101.2 Fe...
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3/18/2021 9:00am Vaccine administered Around 2:00 pm Chills and stomach pain Around 3:00 pm 101.2 Fever, chills, worsening stomach pain, vomiting, light headed Around 5:00 pm went to ER on advisement of Doctors office While in ER experienced more vomiting, fever chill, stomach pain ER administered IV fluids, Tylenol, blood draw 10:00 pm Released from ER and went home 3/19/2021 No appetite, extreme fatigue, some dizziness, slight headache, chills in evening 3/20/2021 Very little appetite fatigued, some dizziness, backache Around 5 pm stomach pain which subsided an hour later, 6:00pm chills
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| 64 | 2021-03-20 | muscle pain, joint pain |
Fever 101.3 Migraine head pain Joint muscle aches Fatigue- 48 hrs Left arm still hurts at injection...
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Fever 101.3 Migraine head pain Joint muscle aches Fatigue- 48 hrs Left arm still hurts at injection site and there is a small lump
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| 64 | 2021-03-20 | neck pain, back pain |
Upper back soreness began ~ 4-5 days after injection. then it began to migrate from the whole upper ...
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Upper back soreness began ~ 4-5 days after injection. then it began to migrate from the whole upper back to the left side near the deltoid and trapezius and get stronger. Then migrate up my neck. It tends to move and is not related to any individual muscle. The pain did not respond to heat, stretching, or massage. It made it feel worse at times. I am very tolerant of pain and rarely take painkillers. I began taking aspirin, oil, then Advil. Then I was in such pain 10 days after the shot, I searched and found my leftover emergency from my hip surgeries. This back and neck pain was more painful to me than hip surgery!
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| 64 | 2021-03-21 | joint pain | Fever. Chills. Nauseous, joint pain, headache Until approx 10 pm sunday night Ok on 3/22/21 |
| 64 | 2021-03-22 | joint pain | Severe pain in left hip area going into upper left thigh |
| 64 | 2021-03-23 | armpit pain | Nausea, Overall body unwell, now a week later, a sore lump in armpit on vaccination arm. |
| 64 | 2021-03-23 | muscle pain, joint pain |
First dose 3/2/21 chills and sore arm. Second dose 3/23/21 sore arm, achy muscles and joints, heada...
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First dose 3/2/21 chills and sore arm. Second dose 3/23/21 sore arm, achy muscles and joints, headache, hives Allergist Dr. recommended Allegra
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| 64 | 2021-03-23 | muscle pain, joint pain |
After one hour develop severe headchage, extrimly tired, body and muscle pain,chills,feeling unwell,...
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After one hour develop severe headchage, extrimly tired, body and muscle pain,chills,feeling unwell,fast heartbeat,join pain
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| 64 | 2021-03-23 | muscle pain | headache, tiredness, low fever, muscle aches, injection site pain. |
| 64 | 2021-03-23 | muscle pain |
fatigue( 5 days- slept and did nothing but lay on the couch) , whole body muscle aches ( 2 days), l...
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fatigue( 5 days- slept and did nothing but lay on the couch) , whole body muscle aches ( 2 days), left arm itchy and red bumps(2 days put cold compresses on it) , very sleepy( slept on couch-3/4 days) , serve headaches (3 days- took Advil every 8 hours and drank 64 ounces of water daily)
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| 64 | 2021-03-23 | neck pain |
Light headed, dizzy,neck pain, tiredness, blood pressure high, nausea Thought I was having a heart...
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Light headed, dizzy,neck pain, tiredness, blood pressure high, nausea Thought I was having a heart attack.
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| 64 | 2021-03-23 | neck pain |
Aside from the soreness of the left arm where I was injected, the left side of my neck and esophagus...
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Aside from the soreness of the left arm where I was injected, the left side of my neck and esophagus is sore and I have numbness on the left side of my face. The numbness is on the left jaw, the cheek, the eye brow and forehead. It's itchy and tingly. It feels somewhat like when a part of the body is coming out of being asleep and it tingles. This is the second day of the numbness. I did not expect this reaction to this COVID-19 vaccination and I have never had such a reaction to vaccinations in the past. I read on the internet of people getting Bell's palsy from the COVID-19 shot and wondered if this is similar. With this reaction from the first COVID-19 shot, I'm concerned what my reaction might be if/when I have the 2nd vaccination.
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| 64 | 2021-03-24 | joint pain | Headache Tired Generalized joint pain |
| 64 | 2021-03-24 | joint pain |
101.5 degree fever, chills, dizziness, tiredness, joint pain (L) leg, feeling unwell, swollen lymph ...
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101.5 degree fever, chills, dizziness, tiredness, joint pain (L) leg, feeling unwell, swollen lymph nodes (L) armpit Lasted 24 hrs Slept most of the time treated with Advil
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| 64 | 2021-03-24 | muscle pain, joint pain |
tiredness; Headache; muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous ...
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tiredness; Headache; muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 13Feb2021 at 14:00 (at the age of 64-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. Concomitant medications were not reported. The patient did not receive any other medications in two weeks. The patient did not receive other vaccines within 4 weeks prior to vaccination. On 13Feb2021 at 22:00, the patient experienced tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell. Therapeutic measures were not given for the events. The clinical outcome of the events tiredness, headache, muscle pain, chills, joint pain, nausea, and feeling unwell was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 64 | 2021-03-25 | back pain |
RIGHT ARM PAIN AND SORENESS X 1 WEEK LATER S/P VACCINATION, WHICH RADIATES TO HAND AND FINGERS, AND ...
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RIGHT ARM PAIN AND SORENESS X 1 WEEK LATER S/P VACCINATION, WHICH RADIATES TO HAND AND FINGERS, AND RIGHT UPPER BACK. MD AT URGENT CARE PRESCRIBED OTC MOTRIN.
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| 64 | 2021-03-25 | back pain |
Pain and tingling in my lower left back started 2 days after the second vaccine. By 5 days after th...
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Pain and tingling in my lower left back started 2 days after the second vaccine. By 5 days after the second vaccine. I had a rash diagnosed on 3/29/21 as shingles. I had never had shingles before.
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| 64 | 2021-03-26 | joint pain |
Very sore arm , more than any other vaccine I have ever received. It has been improving less than 24...
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Very sore arm , more than any other vaccine I have ever received. It has been improving less than 24 hour later. I woke with a fever (my feet were especially warm) Body aches, especially my joints. Mild cough I have taken ibuprofen and acetaminophen, which help. This was my second Pfizer dose. Other than a mildly sore arm, I had no issues with the first dose
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| 64 | 2021-03-26 | muscle tightness, bone pain, muscle pain |
After a 30 minute wait from the shot upon driving home I had a feeling of a very tight grip on the ...
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After a 30 minute wait from the shot upon driving home I had a feeling of a very tight grip on the back of my neck at the base of my skull. It was really tight. My ears itched. This lasted 20 minutes. That night I had severe bone and muscle pain in my upper legs. I cried all night. the next day I started taking Tylenol. This helped. My upper legs still hurt but I can stand it now.
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| 64 | 2021-03-26 | muscle pain | Left arm muscle was sore for 24 hours. |
| 64 | 2021-03-27 | muscle pain |
Felt no systems on the first shot, on the second shot on 3/24 I felt dizzy and nausea when first out...
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Felt no systems on the first shot, on the second shot on 3/24 I felt dizzy and nausea when first out of bed the following day, went back to bed for 2 hours, got up had coffee and toast, back to bed for another 2 hours, felt better but head ache and muscle aches over entire body, and fatigue. Had better strength at times through out day. Went to bed and woke up Friday and felt fine.
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| 64 | 2021-03-28 | back pain, musculoskeletal chest pain |
Pfizer-BioNTech Covid 19 Vaccine Symptoms similar to heartburn: burning acidic pain below my ribs, ...
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Pfizer-BioNTech Covid 19 Vaccine Symptoms similar to heartburn: burning acidic pain below my ribs, excessive burping, burning throat, mouth tasted like metal. It lasted several hours in the evening. I had very little to eat that day. (I have never had heartburn or anything like this before.) Woke up the next morning with body aches and intense back pain and headache.
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| 64 | 2021-03-28 | weight decreased |
Continued side effects (12 days after injection) include: Tremors/Severe Shakes along with Chills o...
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Continued side effects (12 days after injection) include: Tremors/Severe Shakes along with Chills occurring at least twice a day earlier and at night now. The shakes cause my arms/hands to shake hard enough to not be able to hold a piece of paper. They have occurred with sometimes (the heaviest) three comforters on, plus a heavy robe, warm top and three pairs of socks. I have started out with lighter clothes and blankets and work up to the warmer wear. Most chills have woken me up where I have sweated through my clothes. I have never recorded a fever (e.g. 96 to 97 degrees). Headache, body aches, nausea, vomit, loss of appetite (e.g. metal after taste in food), diarreha (I ate small dinner and immediately lost it in the toliet today). I have lost more than ten pounds since my injection. I have been lightheaded, weak, and very fatigued for days. In the last three days, I have had a cough and some congestion in my throat. I have taken sinus medication to address the congestion. I have also been trying to obtain medical advice as to what to do to resolve some of these issues. It is scary because the side effects show no end. I am uncertain if I should take the second shot, if the first dose side effects do not subside or if they are stronger for the second dose. The duration of the side effects and the degree of severity are of concern to me.
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| 64 | 2021-03-29 | joint pain, back pain, musculoskeletal stiffness |
03/26/2021 - We decided to sit for 30 minutes after the injection and were fine. We got home and ha...
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03/26/2021 - We decided to sit for 30 minutes after the injection and were fine. We got home and had lunch and then just took it easy the rest of the afternoon. Around 2pm I took a couple of Tylenol because a headache was forming and my left arm was aching at the injection site. I also noticed a tenderness in the lymph nodes in my groin. I slept mostly well. I did wake up in the middle of the night with the 2 bones in my left foot were throbbing where the screws are. It feels like anywhere I had severe inflammation or surgery, there were intense feelings of burning pain.
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| 64 | 2021-03-29 | bone pain, joint pain, muscle pain |
Mild discomfort at injection site on day of vaccine. Next morning every muscle, joint, bone and hair...
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Mild discomfort at injection site on day of vaccine. Next morning every muscle, joint, bone and hair hurt. Extreme fatigue. Didn't want to keep eyes open. Proceeded to carry on with daily activities, but after 2.5 hours was so fatigued had to be taken home. Took Tylenol 1000 mg for pain relief. Woke up from sleep in about 2 hours because both thumbs and index fingers were in spasm/cramp like a fist and tingling started in right ring, middle and index fingers and left ring finger only. No loss of sensation or capillary refill. Placed wrist braces (for carpal tunnel) to hold fingers in correct position. No real relief, When removed, symptoms were worse. Tingling eventually spread to whole fingers and thumb pad area. Soaked in warm/hot bath for 20-30 min. Slowly noticed relief of tingling. After bath, went back to bed with hands propped on pillows. Slowly over the next hour the spasm/cramps resolved and as well as all tingling. Note: at no time was the ability to move or control all fingers and hands lost. After eating about 1 cup of food, was fatigued and went to sleep. The next morning fatigue remained, but not as bad. Ate 1/2 of a breakfast at 1030. Went immediately back to bed. Upon waking at 1400 it was noted that I must have sweated, but was never aware that there was a fever. at this time all symptoms were resolved. None have followed.
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| 64 | 2021-03-29 | muscular weakness |
at 142pm reports moderate dizziness, left arm numbness and headache. BP=125/82, P=96, o2 sat = 98% ...
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at 142pm reports moderate dizziness, left arm numbness and headache. BP=125/82, P=96, o2 sat = 98% water and cookie given at 1;50pm BS=112, . reports that she hasn't' eaten since 0700and got tired out from standing in line. Denies left arm numbness. reports that the headache is gone, the dizziness is decreased and that she has bilateral le weakness. 205pmunsteady on feet, swaying back and forth and closing eyes when standing Instructed patient to try to keep her eyes open when she is standing. Reports moderate dizziness. At 230pm standing BP 139/86 p=96, T=98.2, 240pm remains unsteady on feet and states that her legs are weak bilaterally. reports that her left arm numbness has returned. Lives with handicapped son who is not able to help if needed. Instructed patient on the need to try to get a family member to drive her home. frequently seen holding her head in her hands. reiterated with the patient on the need to keep her eyes open when standing. reports that she has a hart time drinking any fluids. instructed patient on the need to push fluids and to discuss her dizzy spells with her MD, discharged to the care of her son.
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| 64 | 2021-03-29 | muscle pain | Low grade fever Headache Muscle Aches Exhaustion - slept for more than 24 hours Lack of appetite |
| 64 | 2021-03-30 | joint pain |
Chills, fever thru the night, joints ached, naseaus, and extremely tired. Took extra strength tylen...
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Chills, fever thru the night, joints ached, naseaus, and extremely tired. Took extra strength tylenol every 6 hours. The next day the fever broke but all other symptoms remained. Chills were not as bad. The next day, I was fine, just a little tired. Not much of an appetite.
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| 64 | 2021-03-30 | limb discomfort |
Heart started racing about an hour after vaccine. this stopped after about 10 minutes. At about 7 ...
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Heart started racing about an hour after vaccine. this stopped after about 10 minutes. At about 7 hours later, I became VERY lethargic, had to sit and rest. During the rest I noticed my legs and arms started feeling extremely HEAVY, like they were being filled up with sand or cement. They stayed so heavy that I had to lift my legs off the chair to get up and walk and then they were heavy to move. I developed a headache as well. I did not feel I needed medical attention but I do remember feeling the exact same way AFTER my heart surgery in 2013. I remember telling the ICU nurse back then that I felt like I had sand bags attached to all my limbs, and her response was it was due to my cells being bounced around in the heart lung machine and it would go away over time as my cells healed. So I am thinking this vaccine messed with my cells doing what ever it is doing and has cause damage to my cells causing me the fatigue and thickness as I experienced after my surgery. as I write this I am better, the symptoms have gone but not completely, I feel I will need a few days to recover from this. THEREFORE, I WILL NOT BE GETTING THE SECOND DOSE.
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| 64 | 2021-03-30 | muscle pain, joint pain |
she found out later it was an allergic reaction to the vaccine; blotches/rash all over right side of...
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she found out later it was an allergic reaction to the vaccine; blotches/rash all over right side of face; She had pain, but she didn't feel that it will kill her, it was sort of burns where the red spots/blotches are.; swelling of the face; throat was a little swollen but not bad; little bit of weakness; didn't feel all that great; She isn't sure if she had muscle pain or joint pain, she may have had a little bit of that.; She isn't sure if she had muscle pain or joint pain, she may have had a little bit of that.; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 10Mar2021 (Lot Number: EN6208) (at the age of 64-year-old) as single dose for COVID-19 immunisation. The patient medical history included hearing problem from an unknown date and ongoing. Concomitant medications were not reported. On Mar2021, the patient reported that she started getting blotches all over her face, clarified on the right side of her face, she found out later it was an allergic reaction to the vaccine. 2 days later, she had a few blotches on the left side of her face. She clarifies the blotches have not gone away completely. She had pain, but she didn't feel that it will kill her, it was sort of burns where the red spots/blotches were. The symptoms that she had were swelling of the face, her throat was a little swollen but not bad. She had a rash on her face. She had a little bit of weakness. She didn't feel all that great. She wasn't sure if she had muscle pain or joint pain, she may have had a little bit of that. Therapeutic measures were taken as a result of the events and included treatment with NEOSPORIN (formulation: cream, Lot: 164012, Expiry date: May2022) and BENADRYL (formulation: cream, Lot: 3290LZ, Expiry date: Oct2022) and she mentioned she also took BENADRYL tablets. The patient outcome of the events was unknown.
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| 64 | 2021-03-30 | muscle pain |
fever; she couldn't walk good; muscle aches; This is a spontaneous report from a contactable consume...
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fever; she couldn't walk good; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201, expiry date: Jun2021), in left arm, shoulder area, on 09Mar2021 at 13:30 (at the age of 64-years-old) at single dose for COVID-19 immunization. Medical history included multiple sclerosis (MS), cervical myelopathy, and arthritis that was bone on bone in her right hip. No COVID prior vaccination and no COVID tested post vaccination. The patient had no known allergies. Family medical history relevant to AEs was reported as no. No history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medications included ongoing duloxetine hydrochloride (CYMBALTA), ongoing baclofen, ongoing calcium, ongoing multivitamins (vitamins NOS), ongoing tamsulosin hydrochloride (FLOMAX), ongoing ergocalciferol (VITAMIN D), vitamin D3, diclofenac sodium (VOLTAREN). No additional vaccines administered on same date of the Pfizer suspect, no prior vaccinations (within 4 weeks). The patient reported fever post vaccination. She was told by a nurse to not take MOTRIN but TYLENOL 24 hours after receiving the vaccine. The patient got the vaccine on 09Mar2021 and was told she could not take her MOTRIN. She had multiple sclerosis, cervical myelopathy, and arthritis that was bone on bone in her right hip. She told not to take pain relievers for 24 hours after the shot as it would cause something to happen with the vaccine. Patient explained that when someone had all these different things, it was hard to be told that they could not take medications. After the vaccine, she could not walk good and had a fever. The fever and the other events started on 10Mar2021, about 3am. She could not walk well at 3am in the morning when she got up. When a person had multiple sclerosis, whenever anything happened it took out their legs. It was also noted that she had muscle aches after the shot on 10Mar2021 at 3 am, all of that too. This was getting better. The patient was told she could take TYLENOL and relayed she did take a couple TYLENOL for the fever. The events did not require a visit to emergency room or to physician office. Relevant tests were reported as no. No treatment was administered for muscle ache and walking difficulty. The patient was recovering from the events.
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| 64 | 2021-03-30 | muscle pain | Nausea, vomiting, headache, muscle aches, chills, fever, sore arm, pain in left breast |
| 64 | 2021-03-31 | musculoskeletal stiffness |
Patient is 65 yo female with hx of MS. Reports MS flares have occurred for her in the past when feb...
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Patient is 65 yo female with hx of MS. Reports MS flares have occurred for her in the past when febrile. She reported increased spasticity in her legs, and stiffness the day following the COVID vaccine. It resolved on its own within one day.
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| 64 | 2021-04-01 | joint pain | Chills, achy body swollen arm, achy shoulders, face, neck, joint pain, loss of appetite, fatigue |
| 64 | 2021-04-01 | muscle pain | Fever, chills, very tied, muscle aching, headache |
| 64 | 2021-04-01 | muscle pain |
To begin, I never, ever experience headaches and I never take Tylenol. 7 days after receiving the f...
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To begin, I never, ever experience headaches and I never take Tylenol. 7 days after receiving the first vaccine, on the evening of the 03/31, I developed a severe headache. It felt like a tightness around the perimeter of my forehead. As the night went on, I took 1 table of extra strength Tylenol (Thank goodness my SO had a travel supply in his back pack) and went to bed. The next morning I woke up with a mild headache and started working from home. As the morning went on I developed chills, muscle aches, the headache got worse and I developed a dry cough. Every time I coughed, it hurt my head. After I drank 16 oz of electrolytes and took another tablet of extra strength Tylenol. I started to feel better. Went to bed, however, I was woken up at 1:45AM with the headache again and body chills. When I woke up to start work, I still had the headache. After eating breakfast, I took another tablet of extra strength Tylenol and drank more electrolytes. By mid afternoon, I started to feel better.
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| 64 | 2021-04-02 | back pain, joint pain |
1st Vaccine - uritcaria on hands. Because I suffer from psoraisis, I didn't realize it was related ...
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1st Vaccine - uritcaria on hands. Because I suffer from psoraisis, I didn't realize it was related to the vaccine. Laserr therapy on hands took away the itching, but left dark spots 2nd Vaccine - uritcaria on face, lips and feeling itchy in mouth. severe headache, back and shoulder pain. Treating all uritcaria with cold compress, topical ointments - cortizone 10, ezcema lotion, lanacaine . I also tried Calritin D All aches were treated with Advil and hot and cold compressed pads
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| 64 | 2021-04-03 | muscle pain | High fever (4 degrees elevated), chills, muscle aches, fatigue, head ache |
| 64 | 2021-04-04 | joint swelling |
I have had three adverse events from the second COVID vaccine. 1- After the first vaccination I expe...
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I have had three adverse events from the second COVID vaccine. 1- After the first vaccination I experienced an exacerbation of my Complex Regional Pain Syndrome (reported previously). It subsided in the interim between shots. After my second shot I have another exacerbation of my Complex Regional Pain Syndrome with burning at sites where I have had CRPS in the past. 2- Left arm from shoulder to elbow swollen shortly after the time of 2nd vaccination. It has remained swollen 3 weeks after vaccination. Last Thursday April 1st I received my maintenance dose of my allergy shot one in my left arm and one in my right arm. At the time of the shot I experienced excessive pain in my entire left arm different than with prior shots. My left arm swelled up even more. It is now 2" larger than my right arm. There is still pain and swelling in the left arm but range of motion is intact. Saw the allergist today. Only thing to do is to take an NSAID at this point. 3- joints in my left hand fingers are swollen. They were not swollen prior to the second vaccination. Rings on my left hand ring finger that were loose prior to 2nd vaccination are now tight.
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| 64 | 2021-04-04 | muscle pain, musculoskeletal stiffness |
pt states she started having left leg pain. She has muscle aches and pains in her leg so bad that s...
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pt states she started having left leg pain. She has muscle aches and pains in her leg so bad that she can hardly lift it and has not been able to climb her stairs in her house. She is sleeping sitting up since she cannot lay down. She says her pain level is still a 6 out of 10. Both feet are swollen and lower part of her legs are cold and stiff and the upper part of legs are warm. She has been taking naproxen 520mg to help with the pain. She says this has not helped with the pain. Pt will contact her PCP.
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| 64 | 2021-04-04 | muscle pain |
started on Saturday 4/3 with stiff joints, achy muscles and fatique but by Sunday 4/4 was feeling mu...
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started on Saturday 4/3 with stiff joints, achy muscles and fatique but by Sunday 4/4 was feeling much better
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| 64 | 2021-04-07 | muscle pain |
Severe Nausea; Fatigue; Muscle and body aches; Muscle and body aches; headache; low grade fever; mal...
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Severe Nausea; Fatigue; Muscle and body aches; Muscle and body aches; headache; low grade fever; malaise; severe Tremor; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Mar2021 at 15:15 on the left arm as single dose for COVID-19 immunization. Medical history included bipolar disorder type 2, known allergies to sulfa. Concomitant medications included taking unspecified other medications in two weeks. The patient did not receive other vaccine in four weeks. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies. The patient did not have covid prior vaccination and there was unknown if the patient had covid tested post vaccination. On 13Mar2021 at 12:00 PM, the patient experienced severe nausea, fatigue, muscle and body aches, headache, low grade fever, malaise 3 days after vaccine since then patient had developed a severe tremor; that all events resulted in disability or permanent damage. Patient received a positive result from a serum antibody test for covid 19 on 29Mar2021 (reported as two days ago, as of 31Mar2021). Patient cancelled her second vaccination appointment. Lab data included serum antibody test was positive on 29Mar2021. There was no treatment received for the adverse events. The outcome of events was not recovered. Information about Batch/Lot number has been requested.
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| 64 | 2021-04-11 | muscle pain |
Received second shot in left deltoid 4/3, mylagia 4/4, nausea 4/5, chest pressure and shortness of b...
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Received second shot in left deltoid 4/3, mylagia 4/4, nausea 4/5, chest pressure and shortness of breath started 4/6
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| 64 | 2021-04-14 | joint swelling, joint pain |
Vaccine administered 4.13.21. ED -- > Hospitalized on 4.14.21. Septic arthritis vs. reactive arthr...
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Vaccine administered 4.13.21. ED -- > Hospitalized on 4.14.21. Septic arthritis vs. reactive arthritis vs. other - 64 y.o. female with a history of Crohn's complicated by multiple small-bowel obstructions requiring bowel resection and lysis of adhesions, chronic hyponatremia, hemochromatosis, iron deficiency anemia. She presented to the emergency department with acute left knee and wrist pain. # Knee Pain # Wrist Pain Acute, progressive polyarthritis in the setting of recently receiving her 1st COVID vaccine. Imaging revealed small diffusion in the left knee with concerns for septic arthritis. Arthrocentesis with WBC count 35,000, no organisms or crystals. Labs significant for leukocytosis and elevated CRP and ESR. Pain has progressed to involve multiple joints particularly on the left side. Given polyarticular involvement, reactive arthritis secondary to immunization verses Crohn's disease seems likely, although cannot definitively rule out septic arthritis at this time. Plan: o Monitor off antibiotics for now o Follow blood and fluid cultures o Trend ESR, CRP o Orthopedic surgery following o Pain control with tylenol, oxycodone o Consider GI consult if picture appears consistent with Crohn's related arthropathy # Acute on Chronic Hypo-osmolar Hyponatremia Sodium 125, baseline appears to be 125-130. Thought to be SIADH based on past endocrinology evaluation. Plan: o Check serum, urine osm, TSH, cortisol o BMP daily o 2 L fluid restriction o Hold home spironolactone # Left knee and wrist pain with swelling. Likely secondary to reactive arthritis as a side effect of 1st COVID vaccine on 04/13/2021. White count concerning for septic arthritis of the left knee as well. # leukocytosis with elevated sed rate and CRP, possible reactive arthritis versus septic arthritis -follow-up on cultures from knee arthrocentesis. So far shows a white blood cell count of 35000, no organisms or crystals -monitor complete blood count -orthopedics following -pain control -trend ESR, CRP -monitor peripheral blood cultures x2 -monitor off antibiotics ORTHOPAEDIC TRAUMA CONSULT CC: Swollen, painful joint A: 64 y.o. female w/ with acute onset of left pain, swelling after COVID vaccine concerning for septic arthritis vs gout vs pseudogout. Joint was aspirated, and labs are consistent with reactive arthritis. Anterior femoral cortical defect noted on XR. ESR 47, CRP 10.5, WBC 16, afebrile Recent Labs 04/12/21 1152 04/14/21 0252 WBC 11.32* 16.31* Recent Labs 04/14/21 0252 CREACTIVEPRO 10.5* No results for input(s): SEDRATE in the last 72 hours. P: -CT ordered R/o septic arthritis -Joint arthrocentesis completed in ED -synovial fluid labs- WBC: 32K, gram stain negative, crystals negative -Plan for admission to medicine vs ED obs to monitor cultures given elevated synovial WBC -pain control -ESR/CRP elevated -WBAT LLE -No abx needed at this time for knee
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| 64 | 2021-04-20 | muscle pain |
4/09/21 8p.m. fatigue started and patient went to bed with headache 4/10/21 Nausea, vomiting, muscle...
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4/09/21 8p.m. fatigue started and patient went to bed with headache 4/10/21 Nausea, vomiting, muscle aches, dizziness, pulse slower than usual, low blood pressure. symptoms continued for days 4/14/21 ER. Dehydration secondary to vomiting. Hospitalized overnight. Received IV fluids, IV potassium, and protonix. Patient reported that her troponin was elevated, her potassium was low, but she felt much better after infusions. Patient left hospital AMA 4/15/21. Patient reports she now feels well, just a little fatigue.
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| 64 | 2021-04-21 | neck pain |
Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my lef...
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Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my left side, radiating up into my left ear & across my chest. My chest was tight. It hurt in my neck and shoulder and chest to take a deep breath. Shortly after, I felt jittery inside & started getting chills. The backs of my legs were quaking against the chair and I got really cold. My blood pressure went up to 149/78. I also had one bout of diarrhea.
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| 64 | 2021-04-24 | arthritis, facial discomfort, rheumatoid arthritis |
Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms las...
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Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing; Headache; distorted facial sensory; slight torso rash; tremor; spasticity; cognitive fog; fatigue; joint/tendon stiffness/inflammation; joint/tendon stiffness/inflammation; slightly increased temp; sensory distortion; cutaneous vasculitis on feet (aka "COVID toes"); slow digestion; This is a spontaneous report from a contactable consumer. A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on right arm on 10Mar2021 13:00 (Batch/Lot Number: EN6200) at single dose (at the age of 64 years old) for COVID-19 immunisation. Medical history included known allergies: oats, also saturated fats (trigger multiple sclerosis symptoms), intolerant of many drugs but not allergic, Multiple sclerosis/fibromyalgia, systemic rheumatoid disease, Raynaud's, underweight and very low bone density . Concomitant medications included naltrexone taken for an unspecified indication, start and stop date were not reported. On 11Mar2021, the patient experienced headache and distorted facial sensory, slight torso rash, flare of multiple sclerosis/fibromyalgia and rheumatoid arthritis symptoms with various symptoms lasting a few hours to weeks/continuing. Includes tremor, spasticity, cognitive fog, fatigue, joint/tendon stiffness/inflammation, sensory distortion, cutaneous vasculitis on feet (aka "COVID toes"), slow digestion, slightly increased temp. No new symptoms yet. Postponed 2nd dose due to flare. The patient received no treatment. The outcome of the events was recovering.
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| 64 | 2021-04-26 | weight decreased, back pain |
Acute onset of unspeakable back pain 10/10; Unable to move without screaming and crying; Unable to m...
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Acute onset of unspeakable back pain 10/10; Unable to move without screaming and crying; Unable to move without screaming and crying; Unable to move without screaming and crying; Lost 7.8 lbs in 6 days; This is a spontaneous report from a contactable physician. A 64-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: ER8733), via an unspecified route of administration, administered in Arm Left on 29Mar2021 09:30 (received at 64-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to receiving bnt162b2. Medical history included refractory lymphocytic microcolitis. The patient was not pregnant. She had no COVID prior to vaccination. Concomitant medication(s) included budesonide (BUDESONIDE) taken for an unspecified indication from 01Apr2021 to an unspecified stop date; vedolizumab (ENTYVIO) taken for an unspecified indication from 09Mar2021 to an unspecified stop date. The patient previously took diflucan, nitrofurantoin, flagyl [metronidazole] and experienced allergies (known allergies). On 05Apr2021 06:00 AM, the patient had an acute onset of unspeakable back pain 10/10. She was unable to move without screaming and crying. The patient received Flexeril and was hospitalized 5 days. The patient underwent laboratory test and procedures which included: CRP (C-reactive protein) =170, Sedimentation rate=34. She had no cardio or pulmonary issues. She lost 7.8 lbs in 6 days (weight 103). It was reported that all adverse events occurred on 05Apr2021 06:00 AM. The patient was tested for COVID post vaccination via nasal swab on 02Apr2021 and 07Apr2021 with results of negative. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient received corrective treatment in response to the adverse events, which included Dilaudid and Valium and hold still in bed. Outcome of the events was recovering.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 64 | 2021-05-02 | muscle pain | diarrhea, severe muscle aches, headache, extreme fatigue |
| 64 | 2021-05-04 | joint pain, musculoskeletal stiffness, muscle pain, musculoskeletal chest pain |
Kidney infection; UTI; tightness around her rib cage; size of her arm at the injection site is down ...
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Kidney infection; UTI; tightness around her rib cage; size of her arm at the injection site is down to 2.5 inches by and inch.; allergic reaction; when they injected the vaccine that it burned; lethargic; half a bandage was covered in blood; it felt like three baseballs are sitting on her arm.; The muscles were so tight in her ribcage that she couldn't take a deep breath.; She states that the front of her shoulder, the sides, and the back of her arm was all hard and tense.; teeth chattered after getting the vaccine; Dizziness; difficulty breathing/hard time breathing; headache; fatigue; can still feel where the injection went; feels like an electrical shock; arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting; nerves were jerking starting at her temple going down throughout her body to her arms and fingers; itching; muscle aches; joint aches; arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting; arm pain that radiated under her arm to her rib cage; nerves were jerking starting at her temple going down throughout her body to her arms and fingers; hit a nerve upon vaccination; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6206), dose 1 , single dose via an unspecified route of administration in the right arm on 27Mar2021 at 11:00 (at the age of 64 years-old) for COVID-19 vaccination. Medical history included hypertension from an unknown date and unknown if ongoing History: Caller states that she does have health problems but they are not relevant to this event. She takes high blood pressure medication and is diabetic, diabetes mellitus from an unknown date and unknown if ongoing History: She has health problems but they are not relevant to this event. She takes high blood pressure medication and is diabetic. Hostorical vaccine included tired when she gets flu shot and got the thing where she couldn't lift her arm up and it hurt down the ribcage; still hurts in the lower quarter along the back side of the rib cage; still tender and goes to the bottom where the rib cage ends when she got the pneumonia shot . She is not sure if it effects the lungs more. The patient had no family history relevant to the adverse events. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medications were not reported. The patient experienced kidney infection, urinary tract infection (UTI), itching all over and that lasted two days and didn't get hives, muscle aches and in the beginning she couldn't get out of bed, fatigue, arm pain that radiated under her arm to her rib cage right after the vaccine/arm hurting, hurts down her arm, nerves were jerking, feels like an electrical shock in her, would feel like her eyebrow or her nose would twitch in the center; it was so bizarre, starting at her temple going down throughout her body to her arms and fingers, it was jerking like lightening fire, the jerking started at the temple on right side and went down the face, it made her knees and ankles jerk, her arm was jerking, she still has some jerking in her left hand so it jerks over to the thumb, she can't control that, the nerves were doing their own thing, her leg and knee would move with out her wanting it to, that the moving is still happening in her shoulder, arms, knees, leg, and foot and joint aches, they hit a nerve upon vaccination and can still feel where the injection went on 27Mar2021, headache and difficulty breathing/hard time breathing and changed her position to sitting up more than laying down on 28Mar2021, dizziness on 29Mar2021, really tired for a good week and a half, size of her arm at the injection site is down to 2.5 inches by and inch, arm felt like it was big in the front, on the side and the back, it felt like three baseballs are sitting on her arm, allergic reaction, it burned when they injected the vaccine, more lethargic than normal on an unknown date. It was also reported that she had difficulty breathing, described as tightness around her rib cage on day 3 and was having a harder time breathing when laying down on day 2.5-3. She states that it still hurts down her arm. It took 4 days for her to be able to lift her arm to her head. She didn't want to lift up because it was still tender around the chest area, especially on right side. it was still tender around the chest area, especially on the right side. The muscles were so tight in her ribcage that she couldn't take a deep breath. On an unknown date, half a bandage was covered in blood and the front of her shoulder, the sides, the back of her arm was all hard and tense and teeth chattered after getting the vaccine. There was no laboratory tests performed. Treatment was received for difficulty breathing/hard time breathing and fatigue. She used her inhaler for her breathing and took ibuprofen (ADVIL, lot: RA467, expiration date: Jul 2022) liquid gel minis at night for her pain. She was prescribed cephalexin. She had an albuterol inhaler on the 28th, 29th, 30th, and 31st, so she took that treatment for 3 days. She was only trying to use one dose of the albuterol inhaler because it can raise the blood pressure, but she also wanted to breathe easier. The muscles were so tight in her ribcage that she couldn't take a deep breath. She still has that in the right lower quarter from her back side ribcage under the arm to the side of the leg. The events did not require emergency room or a physician's office visit. The clinical outcome of Itching was recovered on 29Mar2021 and dizziness was recovered on 30Mar2021, headache recovered around 31Mar2021, unknown for her leg and knee would move with out her wanting it to, felt like three baseballs are sitting on her arm, hit a nerve upon vaccination, half a bandage was covered in blood, kidney infection, urinary tract infection (UTI), fatigue, tightness around her rib cage, size of her arm at the injection site is down to 2.5 inches by and inch, allergic reaction, injected the vaccine that it burned and lethargic and recovering for muscle aches, joint aches, difficulty breathing/hard time breathing, pain in arm, nerves were jerking and feels like an electrical shock, arm pain that radiated under her arm to her rib cage and the front of her shoulder, the sides and the back of her arm was all hard and tense.
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| 64 | 2021-05-04 | joint pain, muscle pain |
Monday, the day after the 2nd vaccine injection, I had a Temperature of 103.1, Chills, Muscle & join...
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Monday, the day after the 2nd vaccine injection, I had a Temperature of 103.1, Chills, Muscle & joint pain, dizziness, Fatigue Tuesday day, felt better. I was able to go out to the grocery store. Around 1 p.m. on Tuesday, I began feeling inflammation on the gums of my teeth, and roof of my mouth felt like it was burned; it got so bad that I could not eat or drink due to tongue hitting the roof of my mouth & causing MUCH pain. I did the best I could on Wednesday but then could no longer take it. I contacted my doctor who prescribed viscous lidocaine in order for me to eat & drink. I was only able to eat very soft food. My doctor had not come across anyone with this side effect. But the lidocaine helped a lot and I had to use it for several days. Symptoms started to subside on Saturday and are improving daily but it is still very sensitive even as of this time, 10 days after this 2nd vaccine shot.
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| 64 | 2021-05-06 | joint pain, back pain |
right breast pain; Shoulder pain; can't move shoulder/ can't move her arm/ her shoulder is immobile;...
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right breast pain; Shoulder pain; can't move shoulder/ can't move her arm/ her shoulder is immobile; Shortness of breath; Anxiety; breast is hard; shoulder pain was going down her back to the trapezius/ all the way to the back; This is a spontaneous report from a contactable nurse, the patient. This 64-year-old female patient reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: ER8731) via an unspecified route in the left arm on 18Apr2021 at 12:15 (at the age of 64-years-old) as a single dose for COVID-19 immunization. Medical history included tick bite, blood pressure, nerve pain, gastroesophageal reflux disease (GERD), and sciatica. The patient had no family history. The patient had no other prior vaccinations (within 4 weeks) of the COVID vaccine. Ongoing concomitant medications included olmesartan for blood pressure, duloxetine for nerve pain, omeprazole for GERD, famotidine for GERD; all taken for years, meloxicam for sciatica taken for 2 months and ongoing and doxycycline from 16Apr2021 and ongoing for tick bite (reported that she kept forgetting to take it). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727) on 28Mar2021 at 12:00 in the left arm as a single dose for COVID-19 immunization. That dose went in the deltoid and she had no issues. Then she received the second dose on 18Apr2021 at 12:15 in the left arm. She believes it was administered in the soft tissue behind the deltoid. She noticed the person who gave the injection went behind the muscle toward the back of the arm. The next day after the second dose, she felt fine. Then the second morning it felt as if her shoulder was dislocated; and her breast is hard and painful; and she can't breath. She called her doctor who said that was not a common side effect but she stated she knows it is a side effect. The doctor recommended she go to the ER but patient didn't want to go. She stated that she doesn't know if missing the muscle is going to let the medication absorb or if it has penetrated the soft tissue. The clinical course of events was further described as follows: On 20Apr2021 at 08:00, the second morning, she woke up and felt severe pain in her right breast and shoulder all the way to back; adds she can't move her arm and her breast is so painful she can't touch it and her shoulder is immobile. She is also having very bad shortness of breath, adds she thought that may be from anxiety; so later in the day she took a alprazolam (XANAX). She added that she put up with the pain all morning and thought maybe she was working herself up so she took one half of a Xanax to calm down, to see if it was just anxiety but the shortness of breath and pain were still there. She reported she was continuing to feel all of these effects at the same level. She doesn't want to go to the ER because of the expense. The shoulder pain was going down her back to the trapezius. She clarified that she can move her shoulder and her arm, but the pain was so breathtaking that she doesn't move it and she has her arm in a sling. There were no relevant tests performed. The clinical outcome of the events right breast pain, breast is hard, shoulder pain, shoulder pain going down her back, shortness of breath, can't move shoulder/arm/ shoulder is immobile, and anxiety was not recovered. The patient mentioned that she doesn't know if not getting the shot in the deltoid caused her symptoms or not.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 64 | 2021-05-07 | weight decreased |
feeling so bad; couldn't hold anything down/Vomiting that wouldn't stop/vomiting; Diarrhea; Nauseous...
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feeling so bad; couldn't hold anything down/Vomiting that wouldn't stop/vomiting; Diarrhea; Nauseous; It was just bile coming up; Headache; Was passing clots/were clots/in the vaginal area; Was passing clots/were clots/in the vaginal area/vaginal bleeding; Being dehydrated; couldn't hold her own weight up; stomach pain; So sick; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; A sharp pain in her side; Stools were dark tarry stringy stuff; Stools were dark tarry stringy stuff; Passing blood in her urine; allergic internal reaction; Weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, at age 64 years, administered in left arm on 05Apr2021 10:30 (Batch/Lot Number: ER8734) as single dose, for COVID-19 immunization, in order to go back to normal, without a mask so she was told she had to have one. Medical history included hysterectomy, anxiety, disorder in thyroid and cholesterol. Patient had family history of dementia, had to stay home and take care of her mom who is a heart patient and has dementia. Patient had no history of previous immunizations. Patient's concomitant medication includes unspecified medications one is for thyroid, one is for cholesterol and the other 2 are for anxiety. Patient had no prior vaccinations within 4 weeks. No additional vaccines administered on the same date. Patient's symptoms started with a headache the morning after the shot (05Apr2021), was on and off for a couple of days, lasted 3 days or so for a couple days and she took paracetamol (TYLENOL). On 09Apr2021, Friday morning, patient woke up so nauseous she couldn't hold anything down. It was just bile coming up, and she had severe diarrhea and so sick vomiting that wouldn't stop, stomach pain, couldn't hold her own weight up. She got medication at a walk in clinic and that didn't stop it. She started out at acute/urgent care, where she was taken by her daughter on Sunday, 11Apr2021, because she was feeling so bad and was tested for COVID and they said if it does not get better to go to the Emergency Room and she continued having problems. It was not COVID. They said she was dehydrated and send her home to push fluids and drink Pedialyte. Monday or Tuesday (Apr2021) she was in the ER all night (she does not remember the day because all of her days are mixed up). They did CAT scans on her abdomen and ran blood work. They didn't see anything in her abdomen. Her white blood cell count and kidney and liver function were all elevated and they said it was from being dehydrated from diarrhea and vomiting. They gave her fluids and sent her home. Within another 48 hours she still had vomiting and diarrhea, it was a clear bile and a sharp pain in her side. Her stools were dark tarry stringy stuff so she went back to the ER and waited in the lobby for 9 hours. In that 9 hours as she was waiting, she felt like she had to go to the bathroom. She was then wheeled into the bathroom and started passing blood. It wasn't coming from the urethra. It must have come form the vagina, she doesn't have a uterus. There were clots. She started passing blood in her urine but most was in the vaginal area but she has already had a hysterectomy. She was passing clots and her doctor who works in the healthcare field looked at it and said they were clots. Very shortly after, she passed the clot and the pain went away. The pain was passing clots/were clots/in the vaginal area at one point went away but she still have nausea and diarrhea and they gave her more fluids and sent her home. They didn't really want to address the vaginal bleeding. Patient have not been back and was not sure if she is still dehydrated. Patient was still pushing fluids and still not back to normal. Patient's daughter told her that since it was 5 days later it was not a reaction. Patient was thinking maybe it was an allergic internal severe reaction. Patient was weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter. She stated her daughter-in-law was doing research and found a blog and there are woman the caller's age complaining of these symptoms (unexplained bleeding) after the vaccine. She asked if this was from the vaccine. She stated she was so sick that if there is even a chance then she doesn't want the second dose. She asked if this is a coincidence or has it been reported. She stated she is trying to make a decision on if she should get the second dose because she heard other people have symptoms and take the second shot. The outcome of the events passing clots/were clots/in the vaginal area, headache, a sharp pain in her side, passing blood in her urine, passing clots/were clots/in the vaginal area/vaginal bleeding was recovered on Apr2021, while for the other events, it was unknown.
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| 64 | 2021-05-08 | joint pain, rheumatoid arthritis |
3 days after 1st vaccine experienced excruciating shoulder/elbow joint pain. Unable to comb hair an...
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3 days after 1st vaccine experienced excruciating shoulder/elbow joint pain. Unable to comb hair and much difficulty getting dressed. 2 days after 2nd vaccine experienced severe wrist/finger joint pain. On a scale of 1-10, pain was a 12.
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| 64 | 2021-05-11 | joint swelling |
joint swelling, hives all over the body and would move, muscular swelling , hospitalized on Jan 2n...
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joint swelling, hives all over the body and would move, muscular swelling , hospitalized on Jan 2nd due to facial and neck swelling i am many medications and under a dr. care for on going symptoms now deemed chronic th=e 17th of May will be 5 months
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| 64 | 2021-05-11 | muscle pain |
24 hours post-vaccination, pt developed abdominal pain, dizziness, weakness, frequent diarrhea, myal...
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24 hours post-vaccination, pt developed abdominal pain, dizziness, weakness, frequent diarrhea, myalgias. After 3 days of symptoms, pt was taken to ER by EMS and admitted w diagnosis of colitis, likely ischemic.
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| 64 | 2021-05-12 | muscle pain, joint pain |
Severe headache; Muscle & joint pain; Muscle & joint pain; This is a spontaneous report from a conta...
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Severe headache; Muscle & joint pain; Muscle & joint pain; This is a spontaneous report from a contactable 64-year-old female consumer reported for herself that: A 64-year-old female patient received BNT162B2 (COMIRNAT, solution for Injection, Batch/Lot number: Unknown), via Intramuscular route of administration administered at right arm as single dose on 25Jan2021 11:30 for COVID-19 immunization. The patient was allergies to penicillin, sulfa and codine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history included fibromyalgia, migraines, bipolar disorder, kidney disease and depression sinusitis. Patient has not had symptoms associated with COVID-19. Concomitant medications included Exceeding migraine (ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL), Azelastine HCI and Flucticasone. On 25Jan2021 at 12:15 the patient experienced severe headache, muscle & joint pain lasted 3 days after the vaccination. The events were assessed as non-serious. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On an unspecified date, the outcome of the events were recovering. Follow-up attempts have been completed and no further information is expected.
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| 64 | 2021-05-19 | muscle tightness, back pain, neck pain, musculoskeletal stiffness, joint pain |
felt achy; does not have the energy; sore inside my mouth; sound can hurt my ears; base of my left t...
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felt achy; does not have the energy; sore inside my mouth; sound can hurt my ears; base of my left thumb hurts underneath the thumb where the thumb attaches to the hand; left hand cramp and tightness; Couldn't talk; could barely open her eyes / not be able to open her eyes; fell to the floor; food can taste extra, extra intense; ALT 71 (normal 7-52); sodium 131 (normal 136-144); MCH 34.20 (normal 26-34); MCV 100.30 (normal 80-98); i have a hard time seeing my computer screen; Headache; back pain; neck pain; shoulder pain; short term memory loss/memory problems; skin hurts; flustered; my body temperature, I can be freezing one minute and so hot; brain fog; can't find the words; I feel like I have ADD but on steroids; worked really hard to keep focus; not feeling well; itchy scalp that would be due to the Shingles; Muscle cramps; Muscle tightness; hard to walk; intense anxiety; big emotions, big anger, really really intense; big emotions, big anger, really really intense; exhausted/ fatigue; shingles; like the flu; staring into space; myoclonic jerks; hard time sleeping; stomach gas and bloating; stomach gas and bloating; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EJ1686), via an unspecified route of administration in the left arm on 17Jan2021 (at the age of 64-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing preglaucoma diagnosed 3-4 years ago, ongoing anxiety and depression her whole life, bronchitis at age 5, sinus infections, ongoing sinus allergy "stuff" and allergies (now the patient managed the allergies and did not get sinus infections), "vagititis" over 10 years ago and just essentially being dry, menopause a long time ago, both big toes have some fungus for probably 3 years (toenails look ugly, discolored and thick), ongoing arthritis and bone spurs to C5 and C6 to the area of the neck for which the patient did physical therapy (PT) for about 2 years, low on b-12 when she had shingles last time in 2016, "because I dont want to get Covid" (prophylaxis therapy), nearsighted and wore bifocals. Concomitant medications included bupropion for anxiety and depression for 5 years or longer, loratadine for allergies, COLECALCIFEROL (VITAMIN D3) for depression for 10 (maybe 20) years or more, vitamin b complex (SUPER B COMPLEX) from 2016 and ongoing for "low on B-12", cyanocobalamin (VITAMIN B-12) from 2016 for low B12, latanoprost for preglaucoma, clonazepam from 2012 and ongoing for anxiety, ESTROGENS CONJUGATED (PREMARIN) vaginal cream for "vagititis" and just essentially being dry, ascorbic acid (VITAMIN C) for "because I dont want to get Covid" and an unspecified complete multivitamin for women 50 and older from 2020 "so I wouldn't get Covid". The patient previously got the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK5730) in the left arm on 30Dec2020 (at the age of 64-years-old) for COVID-19 immunization. Around the middle of Feb2021, the patient had a hard time sleeping. She still napped during the day most days. Also around middle of Feb2021, the patient noticed muscle jerks, which came and went. It had gotten worse. The doctor said these were myoclonic jerks. The worst was on 28Mar2021. In the middle of the night, the patient called her on call doctor and asked if it might be a seizure. The physician said it was not a seizure. The weekend of 06Mar2021, the patient started to not feel well. She did not sleep well that Friday or Saturday night. She could not access her memory (short term memory loss) as of 07Mar2021, was flustered and it was clear that something was off as the day progressed. On 07Mar2021, the patient felt her skin hurt, like when you had a fever and the skin hurts. This came and went. Around 07Mar2021, the patient felt intense anxiety which branched out into other intense emotional reactions (big emotions, big anger). On an unspecified date, the patient had a sore inside the mouth. Around 07Mar2021, the patient felt freezing one minute and so hot the next. On 07Mar2021 at 03:00, the patient experienced a bad headache. It was like her neck and her back and her shoulders had intense pain, cramping pain and she had to soak in Epsom salt. The severe headache happened twice, lasted about 2-3 days, moved from the right side of the head, or top of the head. She stayed home from work on 08Mar2021 and 09Mar2021. The patient was exhausted and felt achy, like the flu. She had an appointment with the doctor on 15Mar2021. She was not feeling well at this point. The patient developed shingles (one spot on the right-hand side on back of head) sometime after 15Mar2021 and was diagnosed on 22Mar2021. The patient had an itchy scalp due to the shingles and claimed shingles caused memory issues and brain fog, since 07Mar2021, (it seemed like she got "COVID brain"). The patient was prescribed Valacyclovir 1 mg oral tablet every 8 hours, 30 tablets, for the shingles on 22Mar2021. The open spot on the scalp crusted over by 01Apr2021 when the patient saw the physician again. The patient stated that shingles has lasting effects: brain fog, can't find the words, short-term memory problems have been coming and going since 07Mar2021, felt liked she has attention deficit disorder (ADD) on steroids, worked really hard to keep focus. This has worsened, maybe manifested more so in the last 3-4 weeks or so. Sometimes when she got anxious, her prefrontal cortex did not function well. After being diagnosed with shingles, the patient began to take propranolol 40 mg in Mar2021 as needed (patient takes 1/8 or part of 1/8 of a tablet, just biting off a tiny piece). Initially when she had shingles, she had "some finger in the light socket, fight or flight internally"; the propranolol helped with this. She took it very regularly in Mar2021 and had taken once a week at most the last 2-3 weeks. The patient also took "Brain Goo" as of 22Mar2021 which caused the stinkiest gas in the universe, and the patient was bloated, (reported as from Feb2021) depending on what she ate, and because of that, the following week, the patient took an anti-gas pill, simethicone. She had muscle cramps (in the left upper thigh on the inside of the leg and outside of the leg) and tightness, in Mar2021, that made it hard to walk. The other area that tended to cramp up and cause problems were the arches, mostly the left arch. She reported it was probably 24Apr2021, she came downstairs in the afternoon or early evening and had such an intense cramp like a Charlie Horse and fell to the floor. Muscle cramps come and go, they shift around, it's in the left arch. It's not intensely sharp like it was that day. Right now, her left arch has a knot. The patient began taking tizanidine around 08Apr2021 at 4mg 1 tablet 3 times a day for muscle cramps and tightness, which can get painful, and tizanidine helps relax that. The patient experienced fatigue due to which the patient cannot go to the grocery store by herself very easily as she gets wiped out. The patient had to hang on to the cart because she does not have the energy. She described fatigue and stamina as she had energy for a while and then she crashed. She reported she had to carry protein with her because she can literally crash. She reported her left leg gave out and she had to grab onto the counter and she almost went to the floor. On 24Apr2021, the patient couldn't talk and could barely open her eyes. It felt like her body was shutting down. She couldn't get herself up off the couch to go to the bedroom. This had not happened again. She told her physician about it who was sending her to a neurologist. On 02May2021, her left hand knotted up- had a cramped muscle and tightness. The base of her thumb hurt (underneath the thumb where the thumb attaches to the hand). The patient felt that sound can hurt her ears, which came and went. The patient had a hard time seeing the computer screen, which started between 01Apr2021- 08Apr2021. The patient mentioned this to the physician. She was nearsighted and wore bifocals and will take her glasses off to see the screen better). Food tasted extra intense as of 15Apr2021. On 06May2021, the patient was exhausted after being on the phone so long yesterday. On 06May2021, the patient reported staring off into space "like she could die and it wouldn't matter" and it felt like her brain was cramped up (like her brain was going to shut down). Caller reported that she has been staring off into space steadily, and it was kind of scary. Caller reported that the staring off into space has not occurred again like the first time where she felt like her brain was cramped. Caller reported that she feels like the staring off into space was connected in the same part of her brain that caused her to not be able to talk or open her eyes on the night of 24Apr2021. The patient reported that the staring off into space had continued on and off but not to that degree of intensity. She reported that the first time she stared off into space, she felt like she couldn't interrupt or stop staring off into space. Caller reported that she doesn't know how she stopped starting off into space the first time, but now when she stared off into space she can move her eyes. Caller reported that it felt like she had a cramp in her brain because she couldn't move her eyes. The staring into space was now better otherwise she would have gone to the emergency room. The patient underwent laboratory tests which included on 01Apr2021 which included: ALT 71 (normal 7-52), sodium 131 (normal 136-144), MCH 34.20 (normal 26-34), MCV 100.30 (normal 80-98), and on 02Apr2021, sodium 144, SARS-CoV-2 lgG Ab Antibody Test: reactive (detected value reactive, range non-reactive). The clinical outcome of staring into space, couldn't talk, "could barely open her eyes / not be able to open her eyes" was resolved on an unspecified date; herpes zoster and itchy scalp that would be due to the Shingles, sore inside my mouth was resolved on Mar2021; hard time sleeping, myoclonic jerks, not feeling well, "short term memory loss/memory problems", skin hurts, intense anxiety, "big emotions, big anger, really really intense", "my body temperature, I can be freezing one minute and so hot ", headache, back pain, neck pain, shoulder pain, exhausted/fatigue, brain fog, " I feel like I have ADD but on steroids", worked really hard to keep focus, muscle tightness, "base of my left thumb hurts underneath the thumb where the thumb attaches to the hand", left hand cramp and tightness, i have a hard time seeing my computer screen, food can taste extra, extra intense, was not resolved; flustered, felt achy, like the flu, can't find the words, hard to walk, fell to the floor, does not have the energy, sound can hurt my ears, ALT 71 (normal 7-52), sodium 131 (normal 136-144), MCH 34.20 (normal 26-34), MCV 100.30 (normal 80-98) was unknown; stomach gas and bloating, muscle cramps was resolving. Follow-up attempts are needed. further information is expected
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| 65 | 2021-01-04 | joint pain, muscle pain |
9 to 10 days after administration I started with left shoulder and bicep pain. vaccine was given lo...
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9 to 10 days after administration I started with left shoulder and bicep pain. vaccine was given low in the arm and away from the joint so I did not get concerned at the beginning. The pain has progressed despite range of motion exercises, ibuprofen, heat and topical steroid cream. It has affected the use of my arm and I started myself on 30 mg of prednisone today with concern of SIRVA. I am unable to seek any medical care at this time as I am driving my husband for cancer treatment and won't be home until Saturday the 9th of January. I wanted to report these symptoms so if anyone else has similar symptoms it can be counted.
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| 65 | 2021-01-04 | joint swelling |
swollen arm swollen shoulder and swollen clavicle; lymphadenopathy; hands swelled, were red and itch...
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swollen arm swollen shoulder and swollen clavicle; lymphadenopathy; hands swelled, were red and itchy/swollen arm swollen shoulder and swollen clavicle; body rash to her arms, legs, abdomen with bubbly, clear bumps the size of a pea; hands swelled, were red and itchy; hands swelled, were red and itchy; This is a spontaneous report from a contactable nurse, the patient. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 17Dec2020 (at the age of 65 years old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 18Dec2020, the patient experienced hands swelled, were red and itchy, she took a shower and then experienced a "body rash to her arms, legs, abdomen with bubbly, clear bumps the size of a pea, as well as lymphadenopathy". The next day (19De2020) she started having a "swollen arm swollen shoulder and swollen clavicle". The clinical outcome of "body rash to her arms, legs, abdomen with bubbly, clear bumps the size of a pea, as well as lymphadenopathy" and "swollen arm swollen shoulder and swollen clavicle" was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 65 | 2021-01-04 | muscle pain |
She thought maybe she had food poisoning bc of the weird symptoms; headache; achy muscles; loose sto...
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She thought maybe she had food poisoning bc of the weird symptoms; headache; achy muscles; loose stools; sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), on 20Dec2020 at single dose for covid-19 immunisation. Medical history included None. There were no concomitant medications. The patient experienced loose stools on 25Dec2020, headache on 26Dec2020, achy muscles on 26Dec2020, sore arm on 20Dec2020, she thought maybe she had food poisoning bc of the weird symptoms on an unspecified date. She initially had a sore arm and the usual effects which she expected. Then, about six days into it she started having a headache and achy muscles. It all started with loose stool. She did get a COVID test because of signs of COVID. But it was negative. She thought maybe she had food poisoning bc of the weird symptoms. The headaches were bad, but they were not as bad currently. She had a loose stool that lasted a couple of days. The headaches were really mild currently. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Dec2020. Outcome of loose stools, sore arm was recovered in Dec2020, headache was recovering, achy muscles was not recovered, other was unknown.
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| 65 | 2021-01-04 | neck pain, musculoskeletal stiffness | advanced stiff neck that is not going away pain from bottom of ear down neck to injection site |
| 65 | 2021-01-04 | weight decreased, muscle pain |
Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 ...
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Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Pain, Edema and erythema in 4 cm circumference around injection site; Myalgia; headache; anorexia; fatigue; weight loss; sweats; This is a spontaneous report from a contactable physician (patient). A 65 years old years female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EM9899) via an unspecified route of administration at Left arm on 22Dec2020 01:15PM at single dose for COVID-19 immunization. The patient's medical history included hypertension, body mass index (BMI) 30, hypothyroidism and Covid-19. Known allergies: penicillin, sulpha drugs, seasonal allergies. No other vaccine in four weeks. The concomitant was reported as hydrochlorothiazide, losartan potassium (HYZAAR), levothyroxine sodium (SYNTHROID), Metformin. The patient experienced pain, edema and erythema in 4 cm circumference around injection site myalgia, headache, anorexia, fatigue, weight loss, sweats, all started from 24Dec2020. No treatment received for events. The outcome of the events was recovering.
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| 65 | 2021-01-05 | limb discomfort |
stated that she is having chills; stated that her arm is harsh; stated that her arm is sore; This is...
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stated that she is having chills; stated that her arm is harsh; stated that her arm is sore; This is a spontaneous report from a contactable nurse reported for herself. A 65-year-old female patient received bnt162b2, via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history included covid-19 from Apr2020 to an unknown date. She further stated that she had COVID back in April and survived. Stated that she had the pneumonia part of it and went back to work in June. The patient's concomitant medications were not reported. On an unknown date, patient was having chills since she had the shot. Stated that her arm was harsh and feels real sore. Patient wanted to know if the chills were common. The outcome of the events was unknown. Information on Lot/Batch number has been requested.
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| 65 | 2021-01-07 | joint pain, muscle pain | awake most of the night, body aches, muscle pain, joint pain, chills, nausea, HA, ok today |
| 65 | 2021-01-07 | bone pain | Body aches, bone pain and extreme fatigue, loss of appetite |
| 65 | 2021-01-07 | muscle pain |
Abdominal cramps; "someone's pulling my hair"; headache; muscle pain; feeling sick; feeling warm; Th...
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Abdominal cramps; "someone's pulling my hair"; headache; muscle pain; feeling sick; feeling warm; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unspecified route of administration in the left arm on 02Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included amlodipine (unknown manufacturer) and multivitamins. On 02Jan2021 at 03:00 AM the patient experienced abdominal cramps, "someone's pulling my hair", headache, muscle pain, feeling sick, feeling warm with outcome of recovering. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. No follow up attempts are possible. No further information is expected.
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| 65 | 2021-01-09 | muscle pain |
Vaccinated at 8 am,at about 7 pm I had site and muscle pain 12/31/20,then 48 hours I had loss of s...
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Vaccinated at 8 am,at about 7 pm I had site and muscle pain 12/31/20,then 48 hours I had loss of smell and taste,body aches,I was itchy all over,could not sleep that nite,I called did the Conversation at work and told me not to go to work,the next day 1/3 /21,employee health called me to get tested and tested positive on 1/4/21,I was place on quarantine for 10 days,I tried calling your office with 800 number and left my number nobody called me,I also experienced eye irritation,cough ,short of breath,low grade fever,nausea fatigue
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| 65 | 2021-01-10 | joint pain, neck pain |
Pain in the left shoulder and left base of the neck. Patient received her COVID vaccine on 1/7/2021...
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Pain in the left shoulder and left base of the neck. Patient received her COVID vaccine on 1/7/2021 in the left arm and developed the pain in her left upper shoulder the following morning on 1/8/2021 and continues through today (1/11/2021). Patient has not seen a provider or received treatment at this time, but will see her PCP today.
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| 65 | 2021-01-10 | joint pain |
Numbness of the left side of the face and headache on the left side and part of the tongue; Numbness...
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Numbness of the left side of the face and headache on the left side and part of the tongue; Numbness of the left side of the face and headache on the left side and part of the tongue; The left side of my body, like burning (ankle, elbow); The left side of my body, like burning (ankle, elbow); This is a spontaneous report from a contactable healthcare professional (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular at left arm on 30Dec2020 11:30 at SINGLE DOSE for COVID-19 immunization. Medical history included known allergies to Uva roja. The patient is not pregnant. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was in the Doctor's office/urgent care. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) included atorvastatin (LIPITOR) and fexofenadine hydrochloride (ALLEGRA). The patient previously took titanium and experienced allergies. On 30Dec2020 , the patient experienced numbness of the left side of the face and headache on the left side and part of the tongue. The left side of patient's body, like burning (ankle, elbow). No treatment received for the events. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovered on unspecified date. Information on lot/batch number has been requested.
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| 65 | 2021-01-10 | muscle pain |
I developed rigors with high fever 39.4 C. I was coughing, non-productive cough, pain at the base o...
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I developed rigors with high fever 39.4 C. I was coughing, non-productive cough, pain at the base of my lungs from coughing, running nose, muscle pain, GI problems- vomited once and stool foul smelling, loose. I developed hematuria- visit to Patient first, placed on an antibiotic. Continued with high fever and shivers- went to Emergency Department, admitted. Started on cefuroxime- fever and symptoms subsided. Discharged home. One week at home- getting stronger by day. Back to work January 11, 2021
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| 65 | 2021-01-10 | muscle pain | Headache, Muscle aches and chills |
| 65 | 2021-01-11 | joint pain |
non stop diarrhea; nausea; chills; joint pain; sore at the injection site; This is a spontaneous rep...
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non stop diarrhea; nausea; chills; joint pain; sore at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 02Jan2021 07:30 at single dose for covid-19 immunization. The patient's medical history was none, and there were no concomitant medications. The first dose patient received on 02Jan2021 morning, and she just had symptoms she expected, she was sore at the injection site and she had some joint pain on 03Jan2021, but those disappeared on 04Jan2021. On 05Jan2021, she woke up and had non stop diarrhea with a little bit of nausea. Patient had not had a fever, but did feel chilled. Patient didn't think she ate anything bad. She was suspecting this may be a side effect of the vaccine. Patient didn't have a prescribing doctor. She got it at the hospital she worked at. She received it the 02Jan2021 7:30 am. Patient started the diarrhea on 05Jan2021 morning at 8:30. The nausea was on and off, but started this morning as well. Patient didn't take any ongoing medication. Outcome of events sore at the injection site and joint pain was recovered on 04Jan2021, outcome of event diarrhea was not recovered, and outcome of events nausea, and chills was recovering.
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| 65 | 2021-01-11 | arthritis, joint pain, muscle pain, back pain, neck pain |
Joint pain/Her knee really hurts; Muscle pain; Headache; Chills; Her back hurts, especially at night...
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Joint pain/Her knee really hurts; Muscle pain; Headache; Chills; Her back hurts, especially at night/Her lower back hurts; Her neck is really bad; Her hands hurt; mild arthritis; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via an unspecified route of administration in left upper arm on 30Dec2020 15:20 at single dose for covid-19 immunization in hospital and vaccine was not administered at Military Facility. Medical history included car accident where she broke her neck, usually she is hot all the time, she is a health person and she went the whole year without a cold. There were no concomitant medications. Prior vaccinations included regular flu shot, but she thought it was longer than 4 weeks. There was no vaccines was administered on same date of Pfizer bnt162b2. The patient clarified the side effects she was experiencing as: joint pain, muscle pain, occasional headache, and chills that were coming in and out. The patient explained she got the vaccine on 30Dec2020. The patient started to have the joint pain 3-4 days after getting the vaccine in Jan2021. She stated it was still uncomfortable. Her back hurts, especially at night. It was like all the time, but more so at night. Her neck was really bad. Pretty much every place she had mild arthritis she hurt. She felt it mainly in her neck. She mentioned historically she was in a car accident where she broke her neck. The pain in her neck was almost to the point where she was when she was initially healing from the accident. Her hands hurt. Her lower back hurts. Her knee really hurts. It all hurt more than normal. The muscle pain started 3-4 days after she got the vaccine in Jan2021. The muscle pain was sporadic. She would feel it a little bit and then it went away and then she would feel it again. The headache started within the last 2-3 days in Jan2021. She thought it had gone away for the most part. She just got an occasional headache when her neck hurt a lot. It kind of went with the neck hurting. The chills started around 02Jan2021 or 03Jan2021. Usually she is hot all the time. However, lately she had been feeling chills. She was not sure if it was due to weather or if she was really having chills. This is unusual for her. She stated the chills was kind of the same or maybe a little better. She had a COVID test done on 26Dec2020 which was negative. She had to have the test done for pre-surgical reasons. The adverse events did not require a visit to emergency room or physician office. The outcome of joint pain/knee really hurt, muscle pain and chills were not resolved, outcome of rest events were unknown.
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| 65 | 2021-01-12 | back pain, joint pain |
24 hr after vaccine developed body aches in shoulders, hip and back. Moderate to severe fatigue and...
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24 hr after vaccine developed body aches in shoulders, hip and back. Moderate to severe fatigue and sore left arm at site of injection. Symptoms remained for 36 -48 hrs. Took Tylenol for body aches , increased fluid intake and rested for 2 days. Completely resolved by day 3
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| 65 | 2021-01-12 | neck pain |
Most extreme chills Fever 100 F Headache Neck ache Body aches Fatigue All lasted until about 6pm and...
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Most extreme chills Fever 100 F Headache Neck ache Body aches Fatigue All lasted until about 6pm and then patient was fine. Got Covid at work in March 2020
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| 65 | 2021-01-13 | joint pain |
Awoke on 1/8/21, about 18 hours after injection with body aches and aching joints persisting for the...
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Awoke on 1/8/21, about 18 hours after injection with body aches and aching joints persisting for the rest of the day, taking ibuprofen every four hours. 1/9/21 I woke with moderate itching of scalp, body aches continue. Throughout the day I had large itching whelps at different places on my body. At 11:00am my temperature was 100.5, at which time I also had moderated chills for about an hour. I took ibuprofen and tylenol and benadryl at 4 hour intervals. after the chills stopped (about an hour) symptoms began to calm down. Sunday I woke with no symptoms at all.
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| 65 | 2021-01-14 | muscle pain | CHILLS, HEADACHE, MUSCLE PAIN |
| 65 | 2021-01-15 | muscle pain |
Had fever of 102.3 deg F oral. Took 1000 mg of acetaminophen and fever broke. No further fevers occ...
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Had fever of 102.3 deg F oral. Took 1000 mg of acetaminophen and fever broke. No further fevers occurred. Also had muscle aches during fever.
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| 65 | 2021-01-15 | neck pain | LEFT ARM SORENESS AND NECK PAIN. |
| 65 | 2021-01-17 | joint pain |
Patient reports re-occurrence of Left arm pain, redness, swelling and warmth 10 days post vaccinatio...
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Patient reports re-occurrence of Left arm pain, redness, swelling and warmth 10 days post vaccination. States she had these same symptoms up to 3 days after vaccine but they resolved. She is also reporting onset of headache, joint pain yesterday (9 days post vaccine) and low grade temp today (10 days post vaccine).
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| 65 | 2021-01-19 | muscle pain | fever, myalgia, rash, headache, nausea, fatigue |
| 65 | 2021-01-20 | joint pain |
vaccine was supposed to be in left deltoid. it was injected too high and i am experiencing extreme j...
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vaccine was supposed to be in left deltoid. it was injected too high and i am experiencing extreme joint pain in left shoulder.
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| 65 | 2021-01-21 | joint pain |
First: headache for 6 days. Body aches and low grade temp intermittently. Itching on day 8? Second:...
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First: headache for 6 days. Body aches and low grade temp intermittently. Itching on day 8? Second: chills and low grade temps x 10 days. Joint pain x 10 days. Itching on day 13. Intermittent headaches and brain fog x 10 days.
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| 65 | 2021-01-21 | armpit pain | Severe migraine Brain fog Lymph node under left arm is extremely painful to touch Body aches |
| 65 | 2021-01-21 | muscle pain, joint pain |
First: headache x 6 days . Pruititis day 10 which incurred eruption on finger. Generalized muscle...
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First: headache x 6 days . Pruititis day 10 which incurred eruption on finger. Generalized muscle and joint pain x 7 days with low grade temp and chills. Fatigue Second dose: low grade temp and chills and body aches x 10 days. Fatigue. Brain fog
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| 65 | 2021-01-21 | muscle pain |
Nausea on 1/19. Awoke on 1/20 with extreme muscle aches and fatigue, more nausea in evening, fatigu...
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Nausea on 1/19. Awoke on 1/20 with extreme muscle aches and fatigue, more nausea in evening, fatigue,. Got up on 1/21 still slightly achy but headache all day. Slept a great deal and took advil.
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| 65 | 2021-01-21 | muscle pain | sore arm at the site of injection, mild muscle aches |
| 65 | 2021-01-23 | joint pain |
Reported fever of 101 degrees F yesterday with joint pains and today diarrhea with continued joint p...
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Reported fever of 101 degrees F yesterday with joint pains and today diarrhea with continued joint pains. Has had BM five times already. Temp decreased to 100 degrees F. along with diarrhea and joint point
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| 65 | 2021-01-24 | back pain |
BY the evening I developed a headache and had serve pain for about 5 days in the middle of my back....
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BY the evening I developed a headache and had serve pain for about 5 days in the middle of my back. After that my nose got stocked up and I ended up getting Covid.
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| 65 | 2021-01-24 | muscle pain | Diarrhea Chills Muscle aches Extreme fatigue |
| 65 | 2021-01-25 | joint swelling, joint pain |
Noticed 10 days later, my rt hand 5th digit swollen at the PIP, DIP joints. PIP joint swelling >DIP...
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Noticed 10 days later, my rt hand 5th digit swollen at the PIP, DIP joints. PIP joint swelling >DIP joint with occasional pain at the PIP joint. No recent or remote injury to the digit. Joints are still swollen.
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| 65 | 2021-01-25 | muscular weakness |
post vaccine 15 minutes pt. reports dizziness. EMS evaluation: HR 50-56, pt. reports heart rate not ...
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post vaccine 15 minutes pt. reports dizziness. EMS evaluation: HR 50-56, pt. reports heart rate not usually low. when standing up with EMS, pt. (R) leg weakness. Husband reports vomiting earlier in day. EMS to local hospital.
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| 65 | 2021-01-25 | muscle pain |
First night awoke 3am with muscle pain and fever. By morning also had sinus congestion/headache/eye ...
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First night awoke 3am with muscle pain and fever. By morning also had sinus congestion/headache/eye ache; fatigue. Temp continue to rise throughout day, reaching 100.8 by 5:30pm. All symptoms began to dissipate by 9pm, awakening normal by morning..
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| 65 | 2021-01-26 | muscle pain |
horrible muscle pain in the left leg/ horrible muscle pain in the left side of her leg; This is a sp...
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horrible muscle pain in the left leg/ horrible muscle pain in the left side of her leg; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/bath number and expiration date not provided), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller had been having horrible muscle pain in the left leg for 2 weeks now after her first dose in 21Dec2020 and wanted recommendations on what she should do and if she should get her second dose and what the duration of symptoms was. Caller was asking if she can go back and get the second dose at a later date. Told caller no information regarding use outside of 3 weeks, however, her healthcare professional would have access to information from CDC. Caller was the activity director at a long term care facility. Received first dose of COVID-19 Vaccine on 21Dec2020. Has been having horrible muscle pain in the left side of her leg that had been going on for two weeks. Some days it was really bad. Stated she was in constant pain for two weeks. This happened to be a bad day. Stated it was taking her oxygen just to talk to this the agent. Was very leery about taking COVID-19 Vaccine and this was exactly why. She was agitated. Wanted to know if there's something Had been told there's nothing that can be done and to contact her local provider. She stated that sucks. The patient was due for the second dose in 4 days. Doesn't know if she should take it or not. The event was non-serious per the reporter. The outcome of the event was unknown. Information about lot/batch number has been requested.
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| 65 | 2021-01-27 | muscle pain, muscle tightness |
Headache; Chapped lips; Body is aching from her groin and going down, especially in both thigh areas...
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Headache; Chapped lips; Body is aching from her groin and going down, especially in both thigh areas; Fever; Tightness in jaw; Sore arm and muscles; Sore arm and muscles; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 12Jan2021 08:40 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tightness in jaw within one hour after vaccination and noticed on her way home, sore arm and muscles on 12Jan2021, fever last night (13Jan2021). Her body was aching from her groin and going down, especially in both thigh areas on 13Jan2021. It woke her up. She didn't take anything for it. She laid there until she went back to sleep. It was gone now. The patient also experienced a headache on an unspecified date and chapped lips on 14Jan2021. The outcome of the events chapped lips and headache was unknown, tightness in jaw was not recovered, body is aching from her groin and going down, especially in both thigh areas were recovered while other events were recovering.
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| 65 | 2021-01-28 | joint pain |
01/23/2021 to present: bilateral arthralgias of the hands, wrists, elbows, shoulders, knees, ankles,...
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01/23/2021 to present: bilateral arthralgias of the hands, wrists, elbows, shoulders, knees, ankles, feet. No joint swelling noted.
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| 65 | 2021-01-28 | groin pain |
2nd dose 1/26/2021 on the morning of 1/29/2021 Woke up with intense rash and hives all over my neck ...
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2nd dose 1/26/2021 on the morning of 1/29/2021 Woke up with intense rash and hives all over my neck , inner arms and groins. I was very itchy. After concluding nothing has really changed in my diet, toiletries etc... I read the notice from the vaccine, and went to emergency . Here I was treated for an allergic reaction.
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| 65 | 2021-01-28 | muscle pain |
Very sore shot site and muscle soreness like when I had Covid a little better today but yesterday it...
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Very sore shot site and muscle soreness like when I had Covid a little better today but yesterday it was rough.
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| 65 | 2021-01-30 | back pain, joint pain |
"Pfizer-BioNTech Covid-19 Vaccine EUA Six days after after I received the second dose of the vaccine...
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"Pfizer-BioNTech Covid-19 Vaccine EUA Six days after after I received the second dose of the vaccine I started having a right hip pain. The next day, I started having constant low back pain, bilateral hip pain, left shoulder pain and pain below both thumbs. Aleve relieved the pains only for 6 hours and then start again. My sleep was so disrupted for 7 days. I finally say Dr. on 1/19/2021
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| 65 | 2021-01-30 | muscle pain | Fever 191.2, muscle aches , headache. |
| 65 | 2021-01-31 | back pain |
Body aches, random shooting pains through body. Upper back pain, abdominal pain, severe coughing th...
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Body aches, random shooting pains through body. Upper back pain, abdominal pain, severe coughing that evening, headache, sore arm. Took Tylenol.
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| 65 | 2021-01-31 | muscle tightness |
Rash on face and neck starting within 10 minutes of vaccine. Swelling in cheeks and left neck, and t...
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Rash on face and neck starting within 10 minutes of vaccine. Swelling in cheeks and left neck, and tightness starting in left neck. Itching in the eyes.. Benadryl 50 mg po taken and pepcid 40 mg po taken at home. To emergency room within 1 hour after the vaccine due to tightening and swelling in the neck. They gave me Solumedrol IM and po zyrtec and observed me for awhile. Tightening in the neck eased up and I went home. By bedtime I turned pastey white color, no rash. In the morning I broke out in another rash on my face and neck. Rash resolved by the second day.
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| 65 | 2021-02-01 | joint pain | initial more pain, swelling lasting 1 week with itching, then upper arm pain shoulder pain |
| 65 | 2021-02-01 | neck pain |
Starting on 1/17/21 had fever of 101.6, 1/18/21 fever of 101.2, 1/19/21 fever of 102.6. From 1/19-1...
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Starting on 1/17/21 had fever of 101.6, 1/18/21 fever of 101.2, 1/19/21 fever of 102.6. From 1/19-1/23 she had defervesed to normal temp. Afternoon of 1/23/21 temp 101.4, 1/24/21 fever of 103 and 101. On 1/25/21 the nurses called the doctor and said that she was lethargic. Dr. found her to be hypotensive, lethargic, tacchycardic, They sent her to the ER. She also had during that day they found her with neck pain with movement, chills and fever. From 1/25-today she is still admitted to the hospital. They found her to have staph aureus sepsis - source unknown, encephalopathy related to sepsis, they did rule out meningitis, hyponatremia, UTI with E-coli and some staph, urinary retention, rhabdomyalisis with acute kidney injury and dehydration. They are treating her with antibiotics, getting better but still hospitalized.
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| 65 | 2021-02-02 | joint pain |
16 hours: awakened at 1:30am with joint pain; 19 hours 99.4 temp; 26 hours: 100.5 temp and chills co...
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16 hours: awakened at 1:30am with joint pain; 19 hours 99.4 temp; 26 hours: 100.5 temp and chills continuing through day and night; 34 hours: 102 temp, fatigue; 40.5 hours: awakened with severe headache, fever continues; 46 hours (7am) sweating for about 10 minutes and then all symptoms were completely gone. I took Tylenol or Advil every 4-5 hours. The fever never went down even after taking the Tylenol.
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| 65 | 2021-02-03 | musculoskeletal discomfort, back pain |
a "significant discomfort" on her lower back also described as being "pretty painful"; a "significan...
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a "significant discomfort" on her lower back also described as being "pretty painful"; a "significant discomfort" on her lower back also described as being "pretty painful"; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on Jan2021 (at the age of 65-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no previous back injuries. On an unspecified date in Jan2021, the patient experienced a significant discomfort to her lower back also described as being "pretty painful" during the first two days post vaccination. The clinical outcome of a "significant discomfort" on her lower back also described as being "pretty painful" was resolving, reported as "much better today" and "almost" gone. Information on lot/batch number has been requested.
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| 65 | 2021-02-03 | muscle pain |
After receiving second dose of Phizer COVID19 Vaccine I became ill with shaking chills, muscle aches...
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After receiving second dose of Phizer COVID19 Vaccine I became ill with shaking chills, muscle aches, headaches and fatigue. Event started at home the day after receiving vaccine.
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| 65 | 2021-02-04 | joint pain, muscle pain | Body aches, joint pain, muscle ache, headache, flu like symptoms. |
| 65 | 2021-02-04 | joint pain |
Light headed and mild heart arrhythmia (fast beat). After 10 days, chills, joint pain and sore thro...
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Light headed and mild heart arrhythmia (fast beat). After 10 days, chills, joint pain and sore throat
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| 65 | 2021-02-04 | joint pain |
fatigue; arm soreness; flare up of right hip pain; flare up of right hip pain; This is a spontaneous...
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fatigue; arm soreness; flare up of right hip pain; flare up of right hip pain; This is a spontaneous report from a contactable Nurse (patient). A 65-years-old female patient received second dose of bnt162b2 (BNT162B2, LOT: EL 3248), via an unspecified route of administration from on 10Jan2021 10:30 at SINGLE DOSE on Left arm for covid-19 immunisation. Medical history included Prediabetes, spinal stenosis of right back, right hip pain, known allergies: Penicillin, sulfa, yellow jacket venom. No pregnant. The patient had no covid-prior-vaccination. The patient Historical Vaccine included COVID 19 for covid-19 immunisation at 65 years old, product=COVID 19, brand=PfizerBioN Tech, lot number=EJ 1685, administration date=20Dec2020, administration time=08:00 AM, vaccine location=Left arm; and After 12 hours (08:00 PM) experienced Blurred vision, fatigue , dizziness, tachycardia, arm soreness, after first vaccine 20Dec2020. Concomitant medication included gabapentin (GABAPENTIN), metformin (METFORMIN), paracetamol (TYLENOL), diclofenac (DICLOFENAC), zinc (ZINC). The patient experienced fatigue and arm soreness, and flair up of right hip pain after had received a epidural right hip block 5 days before 2nd injection since Jan2021. No treatment received. The event recovered in Jan2021. No covid-tested-post-vaccination.
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| 65 | 2021-02-05 | musculoskeletal stiffness |
Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection giv...
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Vaccine 10 am- fine all day and evening. Awoke at 3:40 am and rolled off of arm where injection given and a wave of pain and nausea and malaise overwhelmed me. I passed completely out still lying in bed (so out that I wet myself in bed) and gradually came to, still feeling horrible. Got up, changed clothes, and major chills when I returned to bed. Around 6am I felt nauseous, got up to vomit, but instead passed completely out on the bathroom floor for about 15 minutes. Remainder of day I felt very stiff, low energy and slightly woozy. By afternoon, energy was returning (I vacuumed the house). Minimal pain in arm this time compared to previous.
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| 65 | 2021-02-07 | joint pain, back pain, neck pain |
Chills, headache, body aches, joint pain , neck and low back pain, eye and mouth pain, skin sore to ...
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Chills, headache, body aches, joint pain , neck and low back pain, eye and mouth pain, skin sore to touch all over, excessive tiredness, lethargy, loss appetite.
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| 65 | 2021-02-07 | back pain |
Severe Nausea- early morning. At night upon going to bed , severe stomach, abdominal and back pain. ...
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Severe Nausea- early morning. At night upon going to bed , severe stomach, abdominal and back pain. Lasted all night long - could not get into a position to lessen pain. Got out of bed in the morning and sat for a while. Went back to bed a couple hours later, propped myself up on bed, pain subsided after a couple hours. Spoke with the nurse at my doctors-she advised most likely effects from the second COVID shot
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| 65 | 2021-02-08 | joint pain, armpit pain, musculoskeletal stiffness |
My right arm at the injection started aching during the first night. The next day my underarm and s...
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My right arm at the injection started aching during the first night. The next day my underarm and shoulder started hurting and feeling stiff. Hurts to raise my arm.
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| 65 | 2021-02-08 | muscular weakness |
Second COVID vaccine on 1/14/21 - The patient is received her second dose of Pfizer vaccine at Hosp...
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Second COVID vaccine on 1/14/21 - The patient is received her second dose of Pfizer vaccine at Hospital. Post dose she experienced intermittent sensation of tingling on left posterior neck area with no paresthesia and difficulty lifting bilateral extremities. Three days after administration of the vaccine she began noticing weakness in her legs that eventually progressed to her arms bilaterally. She developed pitting edema and SOB. Per infectious disease MD, the main suspicion is for GBS Guillain-Barre Syndrome given exam findings. Pt's weakness and resulting inability to ambulate may have pushed pt into CHF exacerbation. Patient received 3 days of IVIG which was discontinued due to worsening mental status. Naranjo scale score of 2 indicates possible ADR.
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| 65 | 2021-02-09 | arthritis, joint pain |
Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm wa...
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Stomach pain; Nausea; headache; Joint pain; did not feel good; more tired than usual; redness/arm was red; arm was hurting; arm red with a red bump; diarrhea; she has arthritis and her pain has gotten worse; This is a spontaneous report from a Pfizer-sponsored program. A nurse aide (consumer or other non hcp) reported for herself that the 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: E13302), intramuscular injection in the left arm on 20Jan2021 at single dose for COVID-19 prophylaxis. Medical history included ongoing arthritis from an unknown date. Concomitant medication included duloxetine hydrochloride (CYMBALTA) and ibuprofen for arthritis. The patient got the vaccination on 20Jan2021 and experienced redness, pain and nausea on an unspecified date in Jan2021. She said that that night (on 20Jan2021) and the next morning her arm was hurting and it was red with a red bump. On Thursday (21Jan2021) and Friday (22Jan2021), she felt joint pain, no fever, and did not feel good. The patient experienced more tired and did not feel good on 21Jan2021. The patient experienced headache on 23Jan2021. Saturday (23Jan2021) she was more tired than usual and on Sunday (24Jan2021) she was home and felt completely tired and had stomach pain, joint pain, nausea, headache, but did not have a fever. She was feeling the same today (on 25Jan2021) and worse. The patient said that her arm was not red anymore, but it still had a small bump. Stomach pain comes and goes. She stated that she had some diarrhea, but not much in Jan2021. Her nausea comes and goes as well. She said that it was like you want to throw up, but she had not thrown up. She said that you just know that something was not right. She said that her headache was like a heaviness on top of her head and forehead. She said that it was bothering her but it was not terrible. Next dose is due on 10Feb2021. The patient said that she worked in a facility with elderly people. She said that she has arthritis and her pain has gotten worse in Jan2021. She said that even with the medication. She did not take her medication until Thursday evening to see if she had any effects from the vaccine. She took Ibuprofen 800mg and CYMBALTA for her arthritis. She said that her tiredness had nothing to do with her medications. She said that it was very rare that she even had a headache. The reason that she called was to see if she should she do anything, is it safe for her to go back to work. Event Joint pain, more tired and did not feel good were reported as worsened. The outcome of event arm was red was recovered on an unspecified date in Jan2021. The outcome of events arm was hurting, arm with a red bump, diarrhea was recovering. The outcome of events Joint pain, did not feel good, more tired than usual, Stomach pain, Nausea, headache was not recovered. The outcome of the other events was unknown.
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| 65 | 2021-02-09 | back pain, joint pain |
On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, h...
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On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine; This is a spontaneous report from a contactable nurse (patient). A 65-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 11Jan2021 14:00 at SINGLE DOSE on Right arm for covid-19 immunisation. Medical history was none. No-covid-prior-vaccination. No Known- allergies. Concomitant medication included atenolol (TENORMIN), clonazepam (KLONOPIN), sertraline hydrochloride (ZOLOFT), atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]). No-other-vaccine-in-four weeks. Since 19Jan2021, On the 8th day after vaccine, I had 24 hours of stomach ache, chills, fatigue, headache, backache, hip ache, and then stomach ache for a few days, and then totally fine. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit]. No treatment received. Covid-test-post-vaccination: included Nasal Swab, Pixel by Labcorp, covid test date on21Jan2021 was Negative. The event recovered in Jan2021. Information about lot/batch number has been requested.
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| 65 | 2021-02-09 | muscle pain, back pain, joint pain |
feeling pretty bad/ feel awful; she doesn't want to eat; her back hurts; she's irritable; depressed;...
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feeling pretty bad/ feel awful; she doesn't want to eat; her back hurts; she's irritable; depressed; pain in the injection site; joint pain; muscle pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3247), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunization. The patient thinks she could have COVID last Mar2020. She was not sure because her doctor's office was close for around a month and she couldn't get tested. There were no concomitant medications. On that day, 19Jan2021, after she received the vaccine she started feeling pain in the injection site, joint pain, muscle pain and fatigue. On 25Jan2021, she was feeling pretty bad, she doesn't want to eat, her back hurts, she's irritable and depressed. The patient would like to know if these side effects could be associated with the vaccine in someone who had the virus. She felt awful and she felt like she has gone right back to where she was 8 months ago, 10 months ago and started over with fatigue and everything. It was awful. She thinks she could have had COVID in Mar2020 and the symptoms she was having now, she had then and when she has had basically the whole time and that would just come back worse. There was no treatment received for the events. The outcome for the events was unknown.
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| 65 | 2021-02-10 | muscle tightness, joint pain, muscle pain |
Vac administered at 10:30am yesterday. In Observation >10:45am.. no side effects at that time. While...
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Vac administered at 10:30am yesterday. In Observation >10:45am.. no side effects at that time. While in a store buying flowers... approximately 11:45am... experienced sudden and overwhelming onset of profuse heat and perspiration. Eyeglasses immediately fogged up, perspiration ran down my back and ran under my face mask. I felt lightheaded and faint. My husband confirmed that my back was "on fire". Last night, I was awakened by extreme chills and shivering... every muscle and joint tense and painful. This continued for some time and then I became feverish with bed cloths and bedding soaked. Had a temp of 102 @7:30 am with HA and muscle & joint pain.
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| 65 | 2021-02-10 | muscle pain, joint pain |
This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant fe...
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This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number unknown), via an unspecified route of administration on 22Jan2021 at 14:00 (at the age of 65-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included Covid in Mar2020 during which the patient suffered with symptoms and fever for 17 days followed by several weeks of feeling weak. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jan2021 at 19:00, after taking the first dose, the patient experienced tiredness, joint pain, headache, muscle pain, chills, fever of 101.5, and nausea, which the patient stated were the same symptoms the patient had experienced when the patient was diagnosed with COVID-19 in Mar2020. The patient did not receive any treatment for the events. The patient sated these symptoms lasted 2 1/2 days until temp was normal and symptoms started to fade. The clinical outcome of fever was recovered on an unknown date in 2021.The clinical outcomes of tiredness, joint pain, headache, muscle pain, chills, nausea were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 65 | 2021-02-11 | muscle pain |
heaviness and burning in chest, tingling/burning/stabbing pains all over skin, red lesion on center ...
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heaviness and burning in chest, tingling/burning/stabbing pains all over skin, red lesion on center of lower back- felt like WORST SHINGLES ATTACK I'VE EVER HAD and I HAVE HAD THE SHINGRIX VACCINE!, 101 fever, body aches, muscle soreness, fatigue.
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| 65 | 2021-02-11 | neck pain |
Tues: sore arm, sore glands in neck, hurt to turn. Thurs. 2 am.started with Stomach cramps and di...
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Tues: sore arm, sore glands in neck, hurt to turn. Thurs. 2 am.started with Stomach cramps and diahrea also chills . Fri. Am stomach still not feeling great. Some cramping and gas and a little nausea. Feel cold
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| 65 | 2021-02-13 | back pain | Flu symptoms: migraine, chills, body aches and pains, fever, back pain |
| 65 | 2021-02-13 | musculoskeletal discomfort |
Tenderness of deltoid. Fever within 8 hours (2 degrees over baseline temperature), heart rate not b...
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Tenderness of deltoid. Fever within 8 hours (2 degrees over baseline temperature), heart rate not below 100 bpm for 48 hours, fever lasts 48 hours. Headache 3 days with gradual dissipation. Dizziness and nausea begin 6:00am on day 3. Cold sweaty hands and feet along with tremors accompany dizziness.
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| 65 | 2021-02-14 | muscle pain, joint pain | tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell |
| 65 | 2021-02-14 | muscle pain, joint pain |
Injection site soreness; headache (front of forehead across top of head all the way back to ears); s...
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Injection site soreness; headache (front of forehead across top of head all the way back to ears); sinus ache under eyes; muscle ache across shoulders; hint of nausea; early morning awoke to profuse sweating; tired.
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| 65 | 2021-02-14 | muscle pain |
Approximately 10 hours after vaccination (Pfizer-BioNTech Covid-19), developed severe arm pain, feve...
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Approximately 10 hours after vaccination (Pfizer-BioNTech Covid-19), developed severe arm pain, fever of 101.5F followed by shaking chills,, then fever again. Experienced myalgia and severe migraine-like headache with light sensitivity. The arm pain from shoulder to mid-palm was so severe that I couldn?t lift my arm. This resolved by approximately noon on 02/10/2021. The other symptoms largely resolved by midday 02/11/2021 wit residual low-grade headache, dizziness, and unsteadiness on my feet. I woke up on 02/11/2021 around 7AM with left axillary lymphadenopathy approximately the size of a tennis ball cut in half with associated moderate discomfort. The discomfort resolved by 02/14/2021, but the lymphadenopathy remains at about half the mass noticed originally.
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| 65 | 2021-02-15 | bone pain |
Bone directly in front of right ear, as well as the space between the bone and the ear, are tender t...
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Bone directly in front of right ear, as well as the space between the bone and the ear, are tender to the touch. Lower jaw out of whack with upper one, which affected teeth alignment. Painful to open mouth. Much better by Monday. The area by the ear is not nearly as sensitive to the touch, on Tuesday it's gone, but the jaw still doesn't feel normal.
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| 65 | 2021-02-15 | muscle tightness |
Patient received first dose of the COVID vaccine and was monitored for 30 minutes, felt fine at that...
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Patient received first dose of the COVID vaccine and was monitored for 30 minutes, felt fine at that time and was allowed to leave. Approximately one hour after receiving the vaccine patient experienced right side of neck and face up to eye becoming numb and tight. Tongue got a little numb also. Over the next two hours the symptoms lightened up and by morning just felt like she had a numbing agent at the dentist along right lip, nostril and check.
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| 65 | 2021-02-15 | musculoskeletal stiffness, limb discomfort |
She was eating after the vaccine which started as a stiffness, down both of her shoulders and into h...
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She was eating after the vaccine which started as a stiffness, down both of her shoulders and into her waist, severe nauea and headache. She felt like her feet were in cinderblocks. She took some Tylenol, and woke up at 4:00 AM and had two severe headaches and nausea since Sunday. That night she felt as though she could not stand it any longer. Went to UC and they tested her for the virus which was negative, and still having symptoms. She thought the symptoms would get less, but it has been quite a few days. She takes a short walk and the intense pain in her arms, and legs are terrible. Her PCP told her that there was nothing they could do, and what she had been doing what she needed to do. They also told her to go back to UC if she did not improve.
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| 65 | 2021-02-15 | neck pain, muscular weakness, joint pain, musculoskeletal stiffness |
Very Sore rt arm first sx at 2030 pm. Then during night,12 hrs later a headache/posterior neck, uppe...
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Very Sore rt arm first sx at 2030 pm. Then during night,12 hrs later a headache/posterior neck, upper body shoulders to wrists aching. Weakness of upper extremities. 2\16\2021 generalized weakness fatigue,Felt cold, discomfort to skin during shower from water pressure. Difficult getting dressed/ stiffness. Tylenol 500mg q6 hrs and rest all day TX. Feeling better by 4 pm
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| 65 | 2021-02-15 | neck pain |
After client received vaccine client states she has tingling in her fingers, pain in both sides of l...
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After client received vaccine client states she has tingling in her fingers, pain in both sides of lower neck, dry mouth. Vitals obtained by EMS O2 sat 99%, BP 168/87, Pulse 100. Client states she is feeling better. Client discharged home. Client advised to call if symptoms return.
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| 65 | 2021-02-16 | joint pain |
About 10 hours after vaccination a headache started. Then my joints started hurting almost like a ne...
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About 10 hours after vaccination a headache started. Then my joints started hurting almost like a nerve was firing off but only at the joints, ie knee, shoulder, toes, ankle, fingers, toes, etc. It would happen randomly. Never all joints at once. Very weird. Continued throughout the night making it difficult to sleep. In the morning, at 7 am, got up out of bed. Took 2 Advil. At 10:20 I still have the joint happening but not as frequent and not as strong. I still have the headache. It hasn't changed.
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| 65 | 2021-02-16 | joint pain |
My left leg significantly began buzzing for about 6- 7 minutes, then there was some uncomfortable ac...
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My left leg significantly began buzzing for about 6- 7 minutes, then there was some uncomfortable aching pain in that left knee and leg. Have never had this before as a symptom. My heart was racing for 3-5 minutes. Once or twice next 2 days, the leg buzzed for a few minutes and hurt up and down the leg.
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| 65 | 2021-02-17 | back pain, muscle pain |
Forty minutes after the vaccination, the top of my shoulders were a little achy - across my back. Th...
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Forty minutes after the vaccination, the top of my shoulders were a little achy - across my back. This lasted around one hour.; Forty minutes after the vaccination, the top of my shoulders were a little achy - across my back. This lasted around one hour.; I had a metallic taste in my mouth; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), lot number= EL9262, via an unspecified route of administration, in the right arm, on 22Jan2021 at 14:00 (at the age of 62 years-old) as a single dose for COVID-19 immunization. The vaccine administration was given at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor was diagnosed with COVID-19 prior to the vaccination. Medical history included being a breast cancer survivor. Concomitant medication included montelukast sodium (MONTELUCAST) daily, received within 2 weeks of vaccination. The patient previously took LEVAQUIN and LIVALO and experienced an allergy. On 22Jan2021 at 14:45, at forty minutes after the vaccination, the patient reported that the top of her shoulders were a little achy - across the back and also experienced a metallic taste in her mouth. This lasted around one hour. The patient was not hospitalized for the events nor received treatment. The clinical outcome of the events was not reported. Since the vaccination, the patient has not been tested for COVID-19.
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| 65 | 2021-02-18 | armpit pain |
3 hours post vaccine =headache, resolved post Tylenol and aspirin. In the middle of night had achy,...
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3 hours post vaccine =headache, resolved post Tylenol and aspirin. In the middle of night had achy, feverish feeling- no fever. About 26 hours after vaccine=underarm tenderness- unable to palpate anything but very localized, lasted 3-4 days in same location, gradually less tender.
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| 65 | 2021-02-18 | back pain |
Severe to VERY severe continuous lymph node/breast pain on shot side 1/27 through 2/4. Starting 2/4...
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Severe to VERY severe continuous lymph node/breast pain on shot side 1/27 through 2/4. Starting 2/4 intensity started to vary i.e no pain during hot shower but still severe pain majority of time. Slight reduction breast pain as spread to back pain and movement seems to help. On night of 2/3 spread to back ? shot side line of nodes paralleling spine and shoulder/neck area- back pain not as severe as original breast area and heat helps to reduce back pain Pain interferes with sleep - 2/4 finally able to get 4 hours sleep ( hot shower temporary relief while showering)( normal is 7 hrs) As of 2/5 still in moderate to severe breast area pain almost continuously. Hope I am recovering but its 10 days and still mostly constant incapacitating pain. Very slight intermittent node pain by Feb 17 when got second shot in other arm per Physician Assistant?s recommendation. So far after 51 hours 2nd shot adverse effects minimal and does not interfere with thinking or sleeping
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| 65 | 2021-02-18 | muscular weakness | Very bad pain and weakness in left arm and headache |
| 65 | 2021-02-18 | muscle pain |
Day one after vaccine, swelling and soreness of the arm that was vaccinated. 10 days after the vac...
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Day one after vaccine, swelling and soreness of the arm that was vaccinated. 10 days after the vaccine: muscle aches, hand/wrist swelling and pain, and diahrrea on day 13. This has lasted 3 days and has started to subside with the use of ibuprofen every 4 hours. Reported to Dr. on Day 12.
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| 65 | 2021-02-18 | neck pain, back pain |
1 PM I received the vaccine and withing 5 minutes had a slight pain on the left side of my head whic...
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1 PM I received the vaccine and withing 5 minutes had a slight pain on the left side of my head which then continued to a pain in my neck. also left side, then back pain, then slightly short of breath. I remained in the waiting area for over a half hour and felt no worse, but did report it to the young woman at the exit who said that was odd and seemed the kind of response with the second dose. I presumed it might be due to my already having antibodies. As I continued my day those symptoms quickly dispersed and I felt fine, albeit with a light soreness at the site on my left arm. At approximately 6pm I felt very fatigued and rested until 10pm, when I began to have chills, a headache and nausea. My left arm was also so sore I could not lay comfortably. I took Tylenol and aspirin both at 11:30 pm and attempted to sleep, which was fitful and disturbing. I had strange neurological events, such as odd visions in my half sleep and bizarre semi dreams but could not waken. At 4:00 AM I finally was able to pull out of this state and the last thing in my mind was a conversation with someone trying to explain what was happening to me, in my mind not vocal, that was in Italian. That is my second language. All day I had unwanted words, ideas etc. floating about in my brain. I could no longer sleep and was very weak, had terrible head and body aches and my legs also ached terribly. I was also slightly nauseous.These were all symptoms, minus the disturbing neurological one, that I had with Covid. I was too weak to leave the bed until much later in the day. I am still having effects but much less and I am at the 72 hour mark. I remained at rest all day and ran a low fever, then again a fever
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| 65 | 2021-02-21 | joint pain, neck pain |
Feeling mostly normal but tired fell asleep at 11PM day of second vaccine. Woke up 1 hour later and...
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Feeling mostly normal but tired fell asleep at 11PM day of second vaccine. Woke up 1 hour later and got up to go to the bathroom but felt fine. Went out to the hall bathroom so as not to wake husband in Master bath. Urinited and got up slowly as I always do and walked out to the hallway to go back to bed. I lost consciousness and came to when my husband who heard a thud came and found me out having fallen down the stairs.. head on the landing and feet above the landing. I have no recollection of it once leaving the bathroom and i would have headed away from the stairs which was just to the left of the bathroom doorway. I didn't feel any pain. Later found a bump on my forehead of the right side of my face and a bruised lip. He said my back was wet with sweat and I took a couple minutes to come to. After returning to the bed.. i immediately had to empty bowels. Diarrhea.. then the rest of the night in Chills. No fever. Slept most of the next day and night. Headache and joint aches and swelled lymph nodes in neck.. Fatigue through 20th. Mostly better by the 21st. Still today on 22 I am being careful when going from prone to standing. I feel more head pressure getting up and maybe I notice a little nausea when rising. I may just be worried about fainting again. It has never happened to me before. I do have very good blood pressure on the lower side so I was always careful to get up slowly but never fainted. Neck is sore.. Not sure if lymph nodes or something to do with fall.
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| 65 | 2021-02-21 | joint pain | Ongoing right shoulder pain and increased migraines |
| 65 | 2021-02-21 | joint pain |
all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness...
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all over body pain, headache, body ache, joint aches, very sore arm that was hard to move no redness but hot to touch, periodic cough, runny nose, throat felt like it was closing up, extreme fatigue and body weakness, unable to sleep first night
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| 65 | 2021-02-21 | joint pain |
Feeling achy all over body (flu-like) about 8 hours after shot and continued for about 3 days, even ...
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Feeling achy all over body (flu-like) about 8 hours after shot and continued for about 3 days, even soles of feet. Difficulty sleeping that night. Could not sleep on left side for about 3 days. Knees ached, difficulty walking.
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| 65 | 2021-02-21 | armpit pain, joint pain |
I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over a...
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I had injection site discomfort, about 4-6 hours after vaccination. I had generalized aching over all my body (joint/muscle pain) that started about 10 PM the night. I woke up Saturday morning with a bad headache, felt like I was pass out, I had chills. Saturday afternoon I noticed under right armpit the lymph nodes were swollen. The pain radiates throughout my chest and shoulder but most severe under the armpit. As of today 22nd I feel tired and I am still experiencing the swollen lymph nodes under my right arm pit. All the other symptoms have went away. The lymph node feels warm to touch, there is also a small area of redness around the injection site. I am still having post COVID-19 symptoms as well which include nasal issues, weakness and brain fog. I have had all these symptoms since November.
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| 65 | 2021-02-21 | bone pain, back pain |
my results came back stating I was positive; feel ill with a severe back pain on my left side. The s...
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my results came back stating I was positive; feel ill with a severe back pain on my left side. The same side where I was given the shot; cough; runny nose; headaches; a lot of pain in my bones; a lot of pain in my bones, and eye lids; Feel ill; This is a spontaneous report from a consumer (patient). A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on the left arm on 25Jan2021 at 11:00 at the age of 65 years old at a single dose for COVID-19 immunisation at the school/student Health Clinic. Medical history was none. The patient has no allergies to medications, food and other products. The patient is not pregnant and was not pregnant at the time of vaccination. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 at 07:00, patient began to feel ill with a severe back pain on her left side. The same side where she was given the shot. In addition, patient also experienced a cough, runny nose, headaches, a lot of pain in my bones, and eye lids. At first, she believed it was due to the vaccine but as she got worse, she decided to take a COVID test (nasal swab) on 31Jan2021 and the results came back stating she was positive. Since then the patient has been in quarantine. No treatment was received in response to the events. The patient was recovering from the events. The patient has a second vaccination appointment scheduled on 13Feb2021 and would like to know if she will still go as scheduled or will she need to go in a later date. Information on the lot/batch number has been requested.
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| 65 | 2021-02-21 | musculoskeletal stiffness |
sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread th...
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sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; sensations spread through her body/ twitching, burning, cramping, and tingling; she was up all night and couldn't sleep/ restless, had trouble getting sleep, had trouble getting in a comfortable position/ woke up frequently; restless, had trouble getting sleep, had trouble getting in a comfortable position, and woke up frequently.; tightness in her left leg; weird sensations in her legs/ sensations moved to her arms; Ongoing Restasis for Sjogren's syndrome; Ongoing Restasis for Sjogren's syndrome; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: L9261) via an unspecified route of administration on the left arm on 27Jan2021 14:30 at a single dose for COVID-19 immunization. Medical history included ongoing Sjogren's syndrome from 2015 (sees her Rheumatologist/ do blood work once a year to make sure her inflammation levels are okay), ongoing rosacea; dry eye syndrome (related to Sjogren's syndrome); spasming, burning and twitching (last 2 medications she was on in November and January she had similar type reactions in her muscles); arthritis flareup from Oct2019 (in her left leg, she saw her neurologist who did tests and they came back normal) and sinus infection in 2020. Ongoing concomitant medication included ciclosporin (RESTASIS) for Sjogren's syndrome, ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) for blood test: deficient and ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION) for dry eye syndrome related to Sjogren's syndrome. The patient previously took prednisone from Nov2020 and experienced weirdness in her legs got strong enough to keep her up at night and bad flare up for her leg symptoms; metronidazole for flare up or Rosacea (0.75% as needed, which she has used daily for last few weeks), meloxicam in Nov2020 and pantoprazole in Jan2021 and had bad flare up for her leg symptoms (symptoms subsided as soon as she stopped taking the medication after about 5 days); ibuprofen, acetaminophen and pepcid for her stomach. She had the vaccine, her first dose, on 27Jan2021, about a week ago. The first two days she didn't notice anything and then she had weird sensations in her legs on 28Jan2021. The second night she had a weird sensation in her legs which was similar to what she had experienced with the two medications she took in November and January. On 30Jan2021 the sensations spread through her body, she describes these sensations as twitching, burning, cramping, and tingling. She clarifies the sensations moved to her arms which did not happen with the other medications that she tried in November and January. Monday night, 01Feb2021, she was up all night and couldn't sleep and says she called the family doctor yesterday and he called in a prescription for Gabapentin 100 mg. She said she took the medication last night and she did sleep last night, but she was unsure if it was from exhaustion from the last few nights from not sleeping or the medicine, but she did sleep better and her symptoms were a lot less last night. Patient said she wanted to report this and that her concern is with the second dose; will she have a worse reaction, is there anything she can do or take and should she be concerned about it. She said the events gradually increased, they started mildly and then became significant. She felt the sensations a little bit in the day time but they start big time in the night when laying down. These sensations experienced in her legs started the second night, 28Jan2021, and then spread to her arms in the last couple of days which had not happened with her other incidences (with the medications mentioned above back in November and January). Clarified that the sensations spread to her arms on 29Jan2021, but the worst nights were 31Jan2021 and 01Feb2021. She said they were bad nights. She said in regard to her sleeping, starting on 29Jan2021, she was restless, she had trouble getting sleep and trouble getting in a comfortable position. She woke up frequently. Saturday the sleeping was a little worse, but she did sleep. She said on Sunday, 31Jan2021, and Monday, 01Feb2021, she hardly got any sleep. The sensations spread to her arms and it probably started a little on Saturday night, but Sunday and Monday it was very noticeable. She started Gabapentin; it was one a day before bed. The leg symptoms were still there last night. The sensations in her arms were not much at all. She did get up once with the leg cramp and was feeling tightness in her left leg but it never went into a cramp. The cramp was in her right leg, which was unusual because it was usually in her left leg. She stated she was unsure if her symptoms were starting to subside or if the Gabapentin had an immediate effect. The events did not require a visit to physician or ER. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.
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| 65 | 2021-02-22 | muscle pain, joint pain |
In the pt's words " received our second covid-19 vaccination on Sunday. I got my vaccination about 1...
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In the pt's words " received our second covid-19 vaccination on Sunday. I got my vaccination about 10:00. By 8:00 PM I was not feeling well. Had all of the side effects, chills, fever, muscle aches, joint pain and a wicked headache. Monday was the same minus the headache. Today, still have joint pain and feel very weak. The nurse that gave us our vaccinations said that if we experienced any of the side effects, we should let our primary physician know. Hopefully all of this is normal and I will be back to my normal self soon. I am concerned because most of the information I have read says 24 hours and effects should be gone. Not so with me. Hope all is well with you and your family. " Spoke w/ pt on phone and she stated her s/s are subsiding, other than the arthralgia, RN
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| 65 | 2021-02-23 | joint pain, muscle pain |
pt developed rash on b hands that appeared to be chillblains, along with usual side effects of myalg...
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pt developed rash on b hands that appeared to be chillblains, along with usual side effects of myalgias, fever, chills, arthralgias. rash lasted a little over a week and resolved on its own.
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| 65 | 2021-02-23 | back pain |
sudden onset severe mid abdominal pain x hours, one episode of vomiting, then persistent pain which ...
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sudden onset severe mid abdominal pain x hours, one episode of vomiting, then persistent pain which then also radiated to back. Whole episode lasted about 12 hours.
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| 65 | 2021-02-23 | musculoskeletal stiffness |
About 5 minutes after vaccine was given c/o neck feelingstiff and headache. He of migraines, asthma,...
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About 5 minutes after vaccine was given c/o neck feelingstiff and headache. He of migraines, asthma,, and sinuses. States burning feeling is easing yard headache spending to top of head. Client instruct to go home and have husband drive. Plans to take her migrain meds. Says her migraines can start this way too. Left AR 12:13
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| 65 | 2021-02-24 | joint pain, back pain |
She did not have any reactions initially, but noticed the morning after the vaccine that her regular...
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She did not have any reactions initially, but noticed the morning after the vaccine that her regular cup of coffee did not taste good. She then had a rash that started on the left side of her neck, went towards the back now. This started a few days after the vaccine, all on the left side. She also got a cold sore on her lip which she had all the time as a child, but not as an adult, which has pretty much resolved. She has been cold, chills and some dizzy spells. She did get a bump on her head concussion in December. One day last week she just stayed on the sofa with a blanket due to feeling poorly. 3 days ago on her back by her shoulder blade an area has been really sore. She did take some Tylenol for the back pain which did not help so she stopped this. She did not call her doctor. The rash is still there but not as intense. It has not itched, but she has felt it.
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| 65 | 2021-02-24 | muscle pain | Tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell |
| 65 | 2021-02-24 | neck pain, joint pain |
No discomfort until 2:00 a.m. on 2/11. Woke up in intense pain in right arm, shoulder, front right ...
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No discomfort until 2:00 a.m. on 2/11. Woke up in intense pain in right arm, shoulder, front right bodice, up the back of my neck and head on only the right side. I took Tylenol, placed hot packs on the area and drank fluids. I took Advil at 4:00 a.m. Fell asleep and woke up at 8 a.m. I had no temperature but headache was intense. I ate a small breakfast and stayed quiet with hot packs on all areas - 5 p.m. I was feeling much better - went to bed at 7:00 p.m. next morning I was ok.
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| 65 | 2021-02-27 | joint pain |
1. Pain on the injection site (left arm) for 36 hours. I was able to move the arm, there was no swel...
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1. Pain on the injection site (left arm) for 36 hours. I was able to move the arm, there was no swelling. 2. Wrist pain on the left hand, with any movement for 36 hours. I do not have carpal tunnel syndrome. I was not able to do any work because of the pain on one side of the wrist. Pain went away after the second night.
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| 65 | 2021-02-27 | muscle pain, joint pain |
injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swell...
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injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, malaise
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| 65 | 2021-02-27 | muscle pain, joint pain | flu-like symptoms - no fever, muscle and joint aches, headache, flare up of psoriasis, fatigue |
| 65 | 2021-02-27 | muscle pain | Headache, very sore muscles in body as if struck byatruck,fever 100.7 |
| 65 | 2021-02-28 | joint pain |
shaking; chills; loss of appetite; fever; joint pain; headache; This is a spontaneous report from a ...
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shaking; chills; loss of appetite; fever; joint pain; headache; This is a spontaneous report from a non-contactable consumer. A 65-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not available/provided to reporter at the time of report completion), via an unknown route of administration on 25Jan2021 at 10:00 AM at a single dose at the age of 65 years old for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID). Historical vaccine included at the age of 64 years, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 25Jan2021 at 22:00, after receiving 2nd dose of COVID-19 vaccine in morning, patient experienced chills, shaking, fever, joint pain, loss of appetite, and headache later that evening. She stayed home from work for 2 days and felt better 48 hours later. The reporter assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown since the vaccination, if patient was tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 65 | 2021-02-28 | joint pain |
Within a couple hours I had nausea my are hurt and I just didn't feel good. I woke up in the night w...
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Within a couple hours I had nausea my are hurt and I just didn't feel good. I woke up in the night with fever, chills, bad headache and body aches head to toe. Took Tylenol. Woke in the morning with fever (101.8), chills, bad headache, body aches head to toe, joint aches and nausea. Took Tylenol. Too sick to get up all of Saturday. Saturday afternoon vomited. Saturday evening fever broke and began feeling a little better. Sunday still had a bad headache, body aches and joint aches. Today, Monday, feeling better but still have a mild headache, body aches and joint aches. I also feel really week and tired.
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| 65 | 2021-02-28 | back pain |
Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe c...
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Body aches/random shooting pains throughout body; Fatigue; Upper back pain; abdominal pain; severe coughing that evening; headache; very sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EK9231), via an unspecified route of administration on the right arm on 14Jan2021 08:30 at a single dose for COVID-19 immunization at a hospital. Medical history included very chemically sensitive and drug sensitive, interstitial lung disease, and interstitial cystitis. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamin D, zinc, and an unspecified thyroid medication. On 14Jan2021 13:00, the patient experienced body aches, fatigue, random shooting pains throughout body, upper back pain, abdominal pain, severe coughing that evening, headache, and very sore arm. Treatment included self prescribed paracetamol (TYLENOL). Since the vaccination, the patient has not been tested for COVID-19. The patient has not yet recovered from the events.
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| 65 | 2021-02-28 | muscular weakness |
She didn't feel well last night; Weakness in left thigh and leg/leg was so weak she could not get up...
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She didn't feel well last night; Weakness in left thigh and leg/leg was so weak she could not get up; Fell down 3 times; This is a spontaneous report from a contactable consumer (patient) and healthcare professional. A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1283), via an unspecified route of administration on 25Jan2021 11:30 at single dose (arm left) for COVID-19 immunization. Medical history included costochondritis, vertigo, autoimmune disease, uses a walker, inflammation of the cartilage between the rib and sternum and pulled muscle. Concomitant medications included methylprednisolone (MEDROL) (also reported as steroid pak) from Jan2021 to Jan2021 for pulled muscle and ketorolac tromethamine (TORADOL) from Jan2021, both for inflammation of the cartilage between the rib and sternum. The patient previously took iodine and experienced allergies. It was reported that the patient just got the first Pfizer BioNTech Covid-19 vaccine yesterday, 25Jan2021, 11:30 am. Last night, at 19:00, she had weakness on the left side of the body, especially in the thigh, and she fell down 3 times last night. Her leg was so weak she could not get up. She just got off the phone with the doctors office and was told to report this. The patient did not received therapy for the events weakness in left thigh and leg/leg was so weak she could not get up and Fell down 3 times. On 26Jan2021, the patient experienced didn't feel well last night. She was also on a Medrol pack about a week ago and just finished her last dose last night when she took the vaccine. The nurse practitioner at the doctor's office was wondering if it could have been an interaction between the Medrol pack and the vaccine. She got an email saying she could get the vaccine, but didn't think to call the doctor office to ask about the Medrol pack (steroid pack) or if it could cause any interactions. So the office told her to call. Later mentions along with the Medrol pack, she got an injection in the office of Toradol and this was before getting the vaccine. She stated that she did have her on a steroid pack for a pulled muscle so that may have exacerbated the issue. The weakness and things have improved so she was still a little nervous and uses a walker and just making sure to take it easy today. The patient had no other vaccines in 4 weeks and other medications in two weeks included steroid Pak. Patient had no problems with vaccines in the past. The patient had no Covid prior vaccination and was not Covid tested post vaccination. The patient had no events following prior vaccinations. Patient stated that they had been lucky and they have been tested before and has not had it yet, so that was why they wanted to get the vaccine done. She just rested and her husband helped her to bed since she didn't feel well last night. She did not have any trouble breathing. Patient underwent a Chest x-ray in Jan2021 and nothing showed up on it, but just some old calcifications from many years ago. That was done sometime last week and she also had like 3 MRI's on an unspecified date. Patient was wondering if she should she get the second dose. Her next appointment was on 16Feb2021. She was pretty banged up and does not want to have to go through that again. Outcome of events was recovering.
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| 65 | 2021-03-01 | muscular weakness |
Guillain-Barre Syndrome. 3-day hospitalization, IVIg infusion. Symptoms of tingling feet (started in...
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Guillain-Barre Syndrome. 3-day hospitalization, IVIg infusion. Symptoms of tingling feet (started in toes and progressed to whole foot), lower leg weakness and fatigue began 16 days post vaccination. Hospitalization 4 days post symptom onset.
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| 65 | 2021-03-01 | musculoskeletal stiffness |
Approximately 19 hours after having the vaccination, I awoke with a sore arm, stiff neck, and pinpoi...
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Approximately 19 hours after having the vaccination, I awoke with a sore arm, stiff neck, and pinpoint headache. These symptoms continued throughout the day. At approximately 1:30 pm, I took 2x500mg acetaminophen and the stiff neck and headache pretty much went away.
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| 65 | 2021-03-01 | muscle pain, joint pain | Fever, chills, joint and muscle pain, headache, nausea, exhaustion,dizziness |
| 65 | 2021-03-01 | neck pain, muscle pain |
Received 2nd shot around 1:30pm,. Approximately 12 hours after 2nd shot woke up shivering and havin...
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Received 2nd shot around 1:30pm,. Approximately 12 hours after 2nd shot woke up shivering and having muscle cramps in legs and feet. I had to actually get out of bed to try and relieve the cramping. I was cold and muscles were cramping but with extra blankets was able to fall back to sleep. Woke up in the morning feeling very sore with muscle pain/aches. Neck was so sore I could barely keep my head up. My whole body hurt, had a bad headache and fever of 100.4 when I finally took it. For the next 24 hours all I wanted to do was sleep. When I woke up the following morning still had a slight headache that went away as day progressed. Just thought you might want to hear about this. Not sure what you do with this information but hope it is helpful.
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| 65 | 2021-03-01 | weight decreased |
Low grade fever, violent chills, night sweats, swollen neck glands, fatigue, malaise, weight loss la...
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Low grade fever, violent chills, night sweats, swollen neck glands, fatigue, malaise, weight loss lasting 6 weeks
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| 65 | 2021-03-02 | joint pain, muscle pain |
chest pain; dizziness; joint pain; muscle pain; bad headache; Extreme facial swelling began in areas...
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chest pain; dizziness; joint pain; muscle pain; bad headache; Extreme facial swelling began in areas of dermal filler, which was administered 10/2019 and progressed throughout face; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200, expiry date unknown) via an unspecified route of administration on 13Feb2021 13:15 in left arm at single dose for COVID-19 immunization. Medical history included migraine, joint pain and dermal filler in Oct2019; allergies to penicillin, mango, tree nuts, bees, shrimp. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication received within 2 weeks of vaccination included estrogens conjugated (PREMARIN), celecoxib (CELEBREX), levothyroxine, colecalciferol (D3), cyanocobalamin (B12), ascorbic acid (C) and Mul. The patient previously received first dose of BNT162B2 (lot number EL9262), on 23Jan2021 09:30 AM at Left arm. At 4:30 am 14Feb2021, the patient woke with chest pain, dizziness, joint and muscle pain; and bad headache. Extreme facial swelling began in areas of dermal filler, which was administered Oct2019 and progressed throughout face. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Benadryl and Tylenol (today 1 Celebrex). The outcome of the events was recovering. The events were reported as non-serious, did not result in death, life threatening, caused or prolonged hospitalization, disabling or incapacitating, congenital anomaly or birth defect
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| 65 | 2021-03-02 | joint pain, muscle pain |
Severe headache, joint pain, nausea, muscle pain, tiredness, chills with second shot. four days la...
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Severe headache, joint pain, nausea, muscle pain, tiredness, chills with second shot. four days later: itching, redness and welts on over both elbows, knees and ankles.
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| 65 | 2021-03-02 | back pain | Elevated blood pressure, Encephalopathy, Lumbago, Transient global amnesia |
| 65 | 2021-03-02 | muscular weakness |
Pt performed TV with PCP on 2/24/21. Per PCP " She relates that yesterday morning (2/23/21) she got ...
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Pt performed TV with PCP on 2/24/21. Per PCP " She relates that yesterday morning (2/23/21) she got her 2nd COVID-19 vaccination by Pfizer. She had no ill affects until approximately 10:30 p.m. yesterday (2/23/21) at which time she developed chills her symptoms worsened and by midnight she could not move her arms or her legs and her arms and legs felt numb. She did not have any difficulty breathing. She did not have any numbness in her chest and she did not have any shortness of breath. She did not have any rash and she did not have any swelling or have any headache. She relates that she is better now (2/24/21) although she does still feel like she has weakness of her arms and legs she is now able to walk. The only remaining parenthesia is a little bit of tingling in her right arm. She is still experiencing significant fatigue".
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| 65 | 2021-03-02 | muscular weakness |
experience left arm pain radiating from my shoulder down to my fingers; experience left arm pain rad...
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experience left arm pain radiating from my shoulder down to my fingers; experience left arm pain radiating from my shoulder down to my fingers; left arm weakness; This is a spontaneous report from a contactable physician (patient). A 65-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJUe85; expiration date: unknown) at vaccination age of 65-year-old intramuscularly in the left arm on 20Jan2021 10:30 at a single dose for covid-19 immunization. The patient's medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJUe85) at vaccination age of 65-year-old intramuscularly in the left arm on 30Dec2020 at a single dose for covid-19 immunization. The patient received the most recent COVID-19 vaccine in a hospital. On 21Jan2021 after the second Pfizer dose (24 hours after the injection), she began to experience left arm pain radiating from her shoulder down to her fingers. The pain was sharp, constant and associated with left arm weakness. This has persisted for 10 days with no relief and she was still experiencing this pain now. The events were considered as non-serious and did not require treatment. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.
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| 65 | 2021-03-02 | muscle pain |
Low-grade fever, chills, lethargy, muscle soreness; Low-grade fever, chills, lethargy, muscle sorene...
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Low-grade fever, chills, lethargy, muscle soreness; Low-grade fever, chills, lethargy, muscle soreness; Low-grade fever, chills, lethargy, muscle soreness; Low-grade fever, chills, lethargy, muscle soreness; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of bnt162b2 (BNT162B2 also reported as product COVID 19 brandPfizer, lot EL9265), via an unspecified route of administration in left arm on 30Jan2021 13:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included MAC (mycobacterium avium complex) and allergic to strawberries. She had her first dose of bnt162b2 (lot EL3246) on 09Jan2021 in the left arm. The patient's concomitant medications were not reported. The patient previously took rifampin and and experienced, both had drug allergy. On 31Jan2021 12:00, the patient experienced low-grade fever, chills, lethargy, muscle soreness with no treatment. The outcome of events was unknown.
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| 65 | 2021-03-03 | musculoskeletal discomfort |
First Reaction: Three minutes after receiving injection felt lightheaded and dizzy. Symptoms resolve...
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First Reaction: Three minutes after receiving injection felt lightheaded and dizzy. Symptoms resolved with food, water, and time Second Reaction: About 36 hours later while doing dishes, felt prickly on both sides of my neck. Both sides of my neck turned pink as though I had a sunburn. Broke out in profuse sweating. Called my doctor who was on call that night. He told me to get Benadryl right away and to keep taking it until symptoms subsided. If they did not subside or got worse I was to go to urgent care, or ER. Treatment: Benadryl every 4-6 hours for 2 days. As each dose wore off I waited to see if the symptoms came back and then took more Benadryl. Issue lasted until Saturday night - 2 days.
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| 65 | 2021-03-04 | joint pain, muscle pain |
nausea; diarrhea; Could not lift her head because her eyes were hurting. When she opened them it gav...
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nausea; diarrhea; Could not lift her head because her eyes were hurting. When she opened them it gave her a headache; Feeling cold; chills; muscle pain; joint pain; fever; headache/Headaches was reported as worsened; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (also the age at vaccination) receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9263), via an unspecified route of administration at the left arm on 26Jan2021 11:00 AM SINGLE DOSE for covid-19 immunization (reported also as To protect herself). Medical history included that she had a heart cath under anesthesia about two weeks prior to getting the vaccine. She clarifies it was on 30Dec2020. There were no concomitant medications. There was no additional vaccines administered on same date. There was no prior vaccinations (within 4 weeks). No family medical history relevant to AE(s) reported. The patient was vaccinated at a Clinic. The patient previously had a flu shot in Oct2020 and the shingles vaccine in Aug2020 (for immunization). It was reported that the patient had headache, fever, chills, muscle pain, joint pain, nausea and diarrhea after the first dose of the pfizer covid 19 vaccine. The patient wanted to know how long these side effects will last. It was also asked if she should get the second dose of the covid 19 vaccine because she had side effects to the first dose and if the side effects to the second dose or worse than the first dose. It was further reported that the patient got her first shot last Tuesday (26Jan2021). Starting Friday (29Jan2021) she got symptoms. Should she be concerned? She has had tiredness, headaches, (on 27Jan2021) and this morning (01Feb2021) she could not lift her head because her eyes were hurting. When she opening them it gave her a headache. She also had muscle and joint pain (on 29Jan2021) and chills (on 30Jan2021) and fever (on 28Jan2021). She got so cold she covered up with blankets and fell asleep (on 01Feb2021). Then when she woke up it was gone. How long should these side effects last? Should she be concerned? Should she contact her doctor? The reporter also says that most of her symptoms started Friday 29Jan2021. Then she clarifies that actually her symptoms started small before then, on Wednesday 27Jan2021. As the week went on more symptoms came and became other things. It was added that she felt like Friday 19Jan2021 is when she felt the infusion all of a sudden hit her body. That is when she felt the virus hit her with symptoms. Right now her head still hurts. She is not taking as many Tylenol or staying on it regularly like she was. Maybe she should do that again. Could not lift her head because her eyes were hurting. When she opened them it gave her a headache: She says she still has dull pain behind her eyes. She no longer has chills but is feeling cold (on 01Feb2021). Like she chest was frozen on the same side that she got the shot in. They told her to take Tylenol to get relief. But she got concerned as the days went on. She is supposed to get the second dose on 16Feb2021. It was added that it was unknown specific times that these occurred. Friday she would say that she felt it all hit her bad around 11 AM after lunch. The outcome of the event headache, Muscle and joint pain was not recovered; for the event Could not lift her head because her eyes were hurting. When she opened them it gave her a headache and Feeling cold were recovering; for the event nausea, fatigue and diarrhea was unknown; and recovered for the events Chills on 31Jan2021, Fever on 29Jan2021. The AE(s) did not require a visit to Physician office nor ER. Case was considered as non-serious.
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| 65 | 2021-03-04 | joint pain, neck pain |
0913 Pt started having r arm,shoulder,neck pain and HA. VS as follows146/85, HR-71, 02 sat 97%ra,r-1...
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0913 Pt started having r arm,shoulder,neck pain and HA. VS as follows146/85, HR-71, 02 sat 97%ra,r-18.She states no issues with 1st dose on 2/12.0923 Pt report pain and HA has resolved now she feels sleepy. VS as follows 148/86, HR-68, 02 sat 98%, r-20. Pt grandaughter accompanied her here.0937 Pt allowed to go home with grandaughter she reports she feels much better. VS as follows 150/89, HR-77, 02 sat 96%, r-18. Pt instructed to f/u with MD as needed.
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| 65 | 2021-03-04 | neck pain |
Following day around 8pm started having neck pain then numbness in left arm and face with slight hea...
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Following day around 8pm started having neck pain then numbness in left arm and face with slight headache. Lasted two days. Let up a little on third and 4th day. Day 5 almost gone still lingering numbness in left side of face.
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| 65 | 2021-03-05 | joint pain |
Exactly twelve hours after getting the second dose of the Pfizer vaccine, I experienced severe chill...
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Exactly twelve hours after getting the second dose of the Pfizer vaccine, I experienced severe chills for three gruesome hours that rattles my teeth, plus fever, fatigue, & joint pain (especially in my elbows, fingers, shoulder, knees, and back) and headache. My fever ranged from 100 degrees F to 102 degrees F for 36 hours. After consultation with my doctor at the 16 hour mark past vaccination, I took Tylenol every 6 hours to reduce my fever, which helped tremendously. These side effects lasted 36 hours almost to the minute then were gone.
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| 65 | 2021-03-05 | musculoskeletal stiffness |
1) 25 minutes from injection: fluttering heartbeat, hot flush spreading from arm throughout body, we...
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1) 25 minutes from injection: fluttering heartbeat, hot flush spreading from arm throughout body, weakness in arm and then all over, shaking, dry mouth and tongue. The worst of it lasted about 5 minutes but weakness and shaking continued for about an hour. 2) Over the course of several hours developed sore arm and headache which worsened over the next 12 hours but was not terribly bad. 3) Days 3-6 had stiffness which began at injection site and went up left shoulder into the left side of neck. Resolved by day 7. 4) ON DAY EIGHT I developed a rash and itching at the injection site. Also had a dry cough and sinus drainage but cannot be certain this was from the vaccination but the rash and itching definitely was. The rash resolved by day 12. It was not terribly bad and no drugs were needed to calm the itch.
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| 65 | 2021-03-07 | neck pain, joint pain |
slept from Friday pm through Saturday about 2pm,exhausted, slept until 10am Sunday. nightmares, mi...
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slept from Friday pm through Saturday about 2pm,exhausted, slept until 10am Sunday. nightmares, minor sweating. on Sunday began nausea, headache, neck and shoulder aches, fluish, minor sore throat. knew I would sleep heavily again and did.
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| 65 | 2021-03-08 | muscular weakness |
approximately 1 1/2 hours after vaccination, I developed transient nausea, followed by a strange sen...
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approximately 1 1/2 hours after vaccination, I developed transient nausea, followed by a strange sensation in my head, fullness in the ears, ringing associated with nausea, the following day it was worse, upon waking and walking my legs felt rubbery which spontaneously resolved after briefly walking, the nausea, supratentorial symptoms, fullness in the ears persisted, no vomiting, today is the 4th day post injection without improvement. Injection site pain lasted 2 days-not bothersome. Consider my symptoms moderate and interfering with daily activities.
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| 65 | 2021-03-08 | muscle pain |
Fever of 3 degrees, muscle aches and pains, chills, some loss of hearing, brain processing slowness,...
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Fever of 3 degrees, muscle aches and pains, chills, some loss of hearing, brain processing slowness, headache, loss of appetite, dizziness.rash and itchiness of arm.
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| 65 | 2021-03-09 | joint pain |
Starting with my first dose on 2/5/21 my psoriasis and psoriatic arthritis (worsened. After my seco...
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Starting with my first dose on 2/5/21 my psoriasis and psoriatic arthritis (worsened. After my second dose I had chills, lethargy and severe joint and body pain (difficult to sleep) which improved after 36 hours--except worsening of left knee pain--by 3/5/21 I was unable to stand, walk or move my left knee due to pain. I self treated with Naprosyn (400 mg bid) and went to urgent care on 3/6/21. The XRAY was negative with slight effusion. I have had no injuries or trauma to my leg. I am a physician and have had psoriasis and PsA for about 25 years--have on and off medical care (topical steriods, creams and NSAIDS). Due to my +BRCA2 gene I have not taken stronger immuno-suppressive therapies.
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| 65 | 2021-03-09 | muscular weakness |
The day after the vaccination my legs felt weak, that feeling went away in a day I believe. At nigh...
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The day after the vaccination my legs felt weak, that feeling went away in a day I believe. At night my feet are usually cold but I noticed An increased numbness in my toes and tingling. The tingling was daily not just at night . I saw Dr. the end of February for another issue and just mentioned in the past 2 weeks increased tingling in my feet and up to lower half of my legs. I was also having shooting pains in my feet which seems to be getting worse as of today. I?ll call Dr. to report this tomorrow. The pain keeps me awake at night and even wakes me up.
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| 65 | 2021-03-10 | muscle pain |
Rhabdomyolysis; her CPK was over 2400; Muscle cramps/Muscle spasms; Petechia; Dry skin; Itching; Fat...
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Rhabdomyolysis; her CPK was over 2400; Muscle cramps/Muscle spasms; Petechia; Dry skin; Itching; Fatigue extreme/felt tired; Myalgia; Pain; This is a spontaneous report from a contactable Nurse. A 65-year-old female patient received first dose of BNT162B2 (BNT162B2; Lot number EL0140 for both doses, expiry date not reported) via an unspecified route of administration to right deltoid on 23Dec2020 at 15:00 single dose, and second dose via an unspecified route of administration to right deltoid on 13Jan2021 15:15 at single dose for covid-19 immunization, hepatitis a vaccine (HEPATITIS A) intramuscular on 29Dec2020 at single dose for immunization and varicella zoster vaccine rge (cho) (SHINGRIX) intramuscular from 29Dec2020 at single dose for immunization. Medical history included osteoporosis from 2011, osteoarthritis from an unknown date, Knee replacement (Reported due to the osteoarthritis, she had her one knee replaced in 2004 and her other knee replaced in 2011), Spinal compression fracture in 2011 (Reported she fell at work and had a spinal compression fracture in 2011. She said the spinal compression fracture was repaired by a vertebroplasty in 2011) and Hypothyroidism (she has had hypothyroidism for a long time, since either 1998 or 2000). The patient's concomitant medications were not reported. The patient experienced rhabdomyolysis on 06Feb2021, fatigue extreme/felt tired on 30Dec2020, myalgia on 30Dec2020, pain on 30Dec2020, petechia on 06Feb2021, muscle cramps/muscle spasms on 17Feb2021, dry skin on Feb2021, itching on Feb2021 and her cpk was over 2400 on an unspecified date. The patient was hospitalized for rhabdomyolysis from 06Feb2021 to 09Feb2021 and reported to have caused disability. All the other events were reported as medically significant. She said she wanted to report to Pfizer that she was admitted to the hospital on 06Feb2020. She said she was in rhabdomyolysis, and the rhabdomyolysis was really bad. She said she had so much fatigue, myalgia, and pain that she couldn't walk. She said she was given a lot of fluids while she was in the hospital. She said her CPK was over 2400 when she was admitted to the hospital on 06Feb2021. She said she had so much fatigue, myalgia, and pain that she couldn't walk. She said she has a petechia rash, cramps, muscle spasms, dry skin and itching now. Reported she literally saved herself from dialysis by going to the hospital. She said she kept putting off her symptoms, and took Tylenol and Naproxen for the whole month of Jan2021. She said her symptoms started brewing up from day 1, clarifying that her symptoms were not really bad until 30Dec2020 and 31Dec2020. She clarified on 30Dec2020 she took Naproxen, Ibuprofen, and Tylenol for her symptoms, and nothing helped her. She said she knew her symptoms were not normal for her, and she went for the whole month of Jan2021 with her symptoms. She said finally there came a time when she said "oh no, this is not normal at all", and she told herself she needed to check in at the hospital. She said she took Naproxen and Tylenol, and felt a little better, and drove herself to the hospital. Reported she kept walking and taking medicines, and while at work she diverted her mind from her symptoms, but when she came home she felt tired, and would tell herself she couldn't do it anymore. She said she doesn't know if what she experienced was from the COVID-19 Vaccine, but that definitely she had a reaction to either the Hepatitis A booster, the Shingrix Vaccine, or the Pfizer COVID-19 Vaccine. Reported she received 11 bags of Normal Saline (1000ml per bag) while she was in the hospital. She said fluid resuscitation was the only way to bring her CPK levels down and to treat the rhabdomyolysis. Reported her symptoms have improved. She said her last CPK was 134 on Wednesday, 17Feb2021. Reported she had cramps and severe muscle spams in her right leg on 17Feb2021, and then had cramps and muscle spasms in her left leg the following day. She said the cramps and muscle spams have not gone away completely. Reported she has a small petechia rash on her lower legs. She said at the moment the petechia rash shows up on her leg, she knows she is going to have a muscle spasm in that area. She said last night she had 2 petechia rashes show up on the lateral side of her right ankle. She said the petechia rash started to burn, and her right leg calf muscle became heavy. She said she could tell her right leg calf muscle was going to start to spasm, so she took some coconut oil and applied the coconut oil to her right leg calf muscle and massaged her right calf muscle. She said she had 2 areas of petechia last night (23Feb2021). She said the first time the petechia was noticed was when she went to the Emergency Room on 06Feb2021. She said the petechia has been persisting since that time. She said prior to being admitted to the hospital she never had dry skin or itching, but now she has dry skin and itching. She said she was using coconut oil to keep her skin moist. She stated she had 2 telehealth calls (11Feb2021 & 18Feb2021) because of a petechia rash and muscle cramps and was asking her doctor is she may need to go back to the hospital. The patient underwent lab tests and procedures which included blood work, CBC and Thyroid level on 06Jan2021 with unknown results (she had regular blood work done for her yearly checkup on 06Jan2021 (BMP, CBC, and Thyroid level). Also included CPK on 06Feb2021 greater than 2400, CPK on 09Feb2021 566 and CPK on 17Feb2021 134 (units were unspecified), She said her last CPK was 134 on Wednesday, 17Feb2021. Therapeutic measures were taken as a result of rhabdomyolysis, fatigue extreme/felt tired, myalgia, pain, muscle cramps/muscle spasms, her CPK was over 2400. Outcome of the event rhabdomyolysis, fatigue extreme/felt tired, myalgia, pain and her cpk was over 2400 was recovering. Outcome of petechia, muscle cramps/muscle spasms, dry skin and itching was not recovered.; Sender's Comments: Based on the information currently available, a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The Hepatitis A booster and the Shingrix Vaccine may have also played a contributory role. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 65 | 2021-03-11 | joint pain, neck pain |
Extreme migraine. Head pain, neck pain, nausea, vomiting,, dizziness, overall weakness, light sensit...
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Extreme migraine. Head pain, neck pain, nausea, vomiting,, dizziness, overall weakness, light sensitivity. I have migraine disease but since I began Aimovig injections nearly a year ago I have very few migraines, Those I have had have been extremely mild, just headache usually relieved by otc meds. Additionally I have not had nausea and vomiting with any migraine episode for many years. When I woke at yesterday morning, I was in extreme pain across the right side and back of my head and down to my neck and shoulders. 9 out 10. I took my prescription, Eletriptan .5 mg at 5:45 and went back to bed. It gave little relief of symptoms. I was unable to sleep and at about 7 a.m. I was hit with waves of nausea and extreme violent vomiting. This last for several minutes. At approximately 9 a.m. I took a 2nd dose of Eletriptan and slept a little. Again at about 11: a.m. I was hit with another round of extreme nausea and vomiting which lasted about 5-6 minutes. I slept a bit and around 3 p.m. was finally able to drink a little water. Still very weak but pain had subsided significantly, down to about a 4 / 10. By 6 pm. I was almost pain free ? symptom free though very weak still. Ate a little at about 7 p.m. I know this was a migraine which I am diagnosed with but it was extreme even for me, and especially in recent years. It was very unusual in timing and severity and I felt it needed reporting.
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| 65 | 2021-03-11 | musculoskeletal stiffness, neck pain |
stiff/painful neck that started 4 days post-vaccine. "Arthritis of the spine ? took Topamax for a wh...
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stiff/painful neck that started 4 days post-vaccine. "Arthritis of the spine ? took Topamax for a while until she found out she was allergic to it. Takes gabapentin now; with diclofenac. Counseled to take Tylenol every 8 hours on schedule and apply cold packs. Patient was taking ibuprofen prn; advised to discontinue. If event becomes acute: present to ER. If event gets gradually worse: see primary doctor.
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| 65 | 2021-03-11 | neck pain |
Pounding ,throbbing headache so bad I did not want to lift head from pillow. Chills 99.7 temperatu...
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Pounding ,throbbing headache so bad I did not want to lift head from pillow. Chills 99.7 temperature where as my normal temp is nearer97.8. Sickness started almost 24 hour after shot and last about16 hour with aching head and neck.. till next morning
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| 65 | 2021-03-12 | back pain |
1 hour after receiving vaccine became dizzy. It passed within an hour. Following day had severe lowe...
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1 hour after receiving vaccine became dizzy. It passed within an hour. Following day had severe lower burning back pain.. it resolved following day. The next day Feb 11, was severely nauseated all day. Feb 12 nausea resolved. Feb 18 nausea returned. Stomach upset for over 2 weeks then began to resolve. Called Dr . He rec delay 2nd vaccine 1-2 weeks.. Saw Dr on March 8 to discuss 2nd vaccine. Had 2nd vaccine March 11. Same symptoms again but much milder. Also had fatigue for weeks after 1st vaccine and again after 2nd vaccine. .
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| 65 | 2021-03-12 | muscle tightness |
Within 10 minutes I felt faint, my neck tightened, headache started.. Still have a headache 5 weeks...
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Within 10 minutes I felt faint, my neck tightened, headache started.. Still have a headache 5 weeks later
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| 65 | 2021-03-12 | muscle pain |
Within 30 minutes upper body muscles became very achy. Within next hour sinus tickle and nose runnin...
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Within 30 minutes upper body muscles became very achy. Within next hour sinus tickle and nose running. Within two hours a tickling discomfort in lungs, coughing. (Left lung in particular.) Remembered then in early 2000's had pneumonia several times with scarring on left. Monday evening while trying to sleep much sneezing, nose blowing, fluids moving into chest and by morning a severe left calf cramp for which I had to stand up to relieve. Leg very sore until the 12th. Been very cold all week.
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| 65 | 2021-03-12 | muscle pain | I experienced sore arm, chills, muscle aches, and headache. I remained in bed for the whole day. |
| 65 | 2021-03-13 | joint pain |
Slight headache right after. I took Tylenol. After 12 hrs, rash on chest, stomach and legs. I too...
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Slight headache right after. I took Tylenol. After 12 hrs, rash on chest, stomach and legs. I took Benadryl. 2nd Day, Next morning: headaches. Tylenol. Foggy and not clear headed. L arm hot and hurts, Hip, knee and ankle on L side painful. Very tired. Rash is gone. Mid day: anxiety and feeling down. Called Dr. and got nurse and then called therapist. headache still continues. I took a nap, I never take naps unless very sick. Eve: Rash came back. Benedryl Headache. Tylenol 3rd day: Diarrhea. headache, still foggy and tired.
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| 65 | 2021-03-13 | joint pain |
Pain in shoulder and arm. Limited motion with shoulder. Pain radiates down the arm. Pain when using...
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Pain in shoulder and arm. Limited motion with shoulder. Pain radiates down the arm. Pain when using the arm.
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| 65 | 2021-03-13 | joint pain |
Very severe headache, pain at injection site, chills, sweating, cough, malaise, R hip pain (osteopen...
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Very severe headache, pain at injection site, chills, sweating, cough, malaise, R hip pain (osteopenia), fatigue
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| 65 | 2021-03-13 | muscle tightness, muscle pain |
Developed macular papular rash on upper left trapezius about 1 in in diameter with small clear fl...
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Developed macular papular rash on upper left trapezius about 1 in in diameter with small clear fluid papules and another spot over the left scapula with clear fluid papules over left scapula about 1 in in diameter including area of erythema around lesions at 72 hours post second shot. At 96 hours 4 spots of rash on upper middle chest and left lateral upper chest. Clear fluid oozes from papules and lesions scab over. Severe itching. Also tenderness and tightness over left trapezius.
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| 65 | 2021-03-15 | armpit pain |
Left arm swelled, pain at injection sight all the way down outside of arm stopping at wrist, then t...
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Left arm swelled, pain at injection sight all the way down outside of arm stopping at wrist, then traveling up inside of arm to arm pit. pain subsided but arm is still swollen as of today 03/16/2021.
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| 65 | 2021-03-15 | muscle pain |
No side effects were experienced until 2 days after I received the vaccine. Two days after I receiv...
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No side effects were experienced until 2 days after I received the vaccine. Two days after I received the vaccine I experienced enlarged lymph nodes on the left side of my back. I experienced pain when I pressed on my back. The pain felt like sore muscles so I used a heating pad which did not alleviate the issue. The enlarged lymph nodes continued to increase to include pain from my left arm pit down my left arm to my forearm and shoulder blade. It also increased down my back into my left buttock and upper thigh. As of today, March 16, 2021 at 3pm, the pain has slightly decreased.
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| 65 | 2021-03-15 | neck pain, joint pain |
Prior to vaccine took 2 acetominophen. Upon injection had sensation of an angry bee sting that subs...
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Prior to vaccine took 2 acetominophen. Upon injection had sensation of an angry bee sting that subsided in a few minutes. Left shoulder, neck & arm very sore, iced injection site within 1 hour of receiving. Early evening, didn't feel well-- upset stomach, loss of appetite, head ache, lethargic. Ended up sleeping abnormal amount over next 3 days with aches in joints, specifically in hands & knees.
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| 65 | 2021-03-16 | muscular weakness |
1st day after-fatique/headache/weakness/chills 2nd day- better 3rd day- dizziness started late nigh...
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1st day after-fatique/headache/weakness/chills 2nd day- better 3rd day- dizziness started late night, subsided next morning. 4th day- same as 3rd 5th day- extreme dizziness at night, continued next day with sick feeling, stomach pain, leg weakness. Heart palpitations and racing(during night) Symptoms continued following 6th-10th days. Went to hospital emergency room 11th day due to doctor concerns of possible aFib. Admitted in Observation Unit overnight with IV fluids & heart monitor. Heart attack ruled out. Tachycardia event with follow up at cardiologist.
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| 65 | 2021-03-17 | joint pain |
Dizziness (like shock); Dizziness (like shock)/unable to stand or sit-up; Painful dry mouth and swal...
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Dizziness (like shock); Dizziness (like shock)/unable to stand or sit-up; Painful dry mouth and swallowing; Painful dry mouth and swallowing; Intense joint pain; This is a spontaneous report from a contactable consumer reporting for herself. A 65-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EN5318) vaccine , via an unspecified route of administration in the left arm on 28Jan2021 14:15 at single dose for Covid-19 immunisation . Medical history included systemic lupus erythematosus , Raynaud's phenomenon , intervertebral disc degeneration, arthritis , migraine , blood cholesterol increased , hypersensitivity. Concomitant medication included atorvastatin calcium (LIPITOR), hydroxychloroquine sulfate (PLAQUENIL), estrogens conjugated (PREMARIN), rizatriptan benzoate (MAXALT), venlafaxine hydrochloride (EFFEXOR). The patient experienced dizziness (like shock)/unable to stand or sit-up on 28Jan2021 03:30 with outcome of recovering , painful dry mouth and swallowing on 28Jan2021 03:30 with outcome of recovering , intense joint pain on 28Jan2021 03:30 with outcome of recovering. The events Shock-like symptom and dizziness postural were considered Important Medical Events. Since the vaccination, the patient has not been tested for COVID-19 Follow up information has been requested.
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| 65 | 2021-03-17 | joint pain |
The morning after the shot I began to feel achy in joints, headache, upset stomach and slight nause...
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The morning after the shot I began to feel achy in joints, headache, upset stomach and slight nausea, my arm hurt at the site, Temp 98.9 temporal. I took Ibuprofen, worked and 6 hours later felt the same so repeated Ibuprofen and then it was over with. No further untoward problems. The injection site still hurt 2 days and was bruised 3 days.
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| 65 | 2021-03-17 | musculoskeletal stiffness |
On 3/5 Body aches and stiffness started that lasted about two days. No treatment and it went away by...
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On 3/5 Body aches and stiffness started that lasted about two days. No treatment and it went away by itself.
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| 65 | 2021-03-18 | joint pain, muscle pain |
uncomfortably hot ankles and feet; Low grade fever; soreness at injection site; tiredness; headache;...
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uncomfortably hot ankles and feet; Low grade fever; soreness at injection site; tiredness; headache; muscle and joint pain; muscle and joint pain; This is a spontaneous report from a contactable consumer, the patient. A 65-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EL9266), via an unspecified route of administration in the right arm on 19Feb2021 at 12:00 PM (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included atenolol (ATENOLOL), pravastatin (PRAVASTATIN), eicosapentaenoic acid ethyl ester (VASCEPA) and multivitamin, all were taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 (lot number: EL9264), via an unspecified route of administration in the left arm on 29Jan2021 at 01:15 PM (at the age of 65-years-old) for COVID-19 immunisation, prochlorperazine maleate (COMPAZINE) and experienced Compazine allergy and codeine and experienced codeine allergy. The patient did not receive any other vaccines within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced low grade fever, soreness at injection site, tiredness, headache, muscle and joint pain, including uncomfortably hot ankles and feet on 19Feb2021 at 11:00 PM. The patient did not receive treatment for the events. The outcome of events, low grade fever, soreness at injection site, tiredness, headache, muscle and joint pain, including uncomfortably hot ankles and feet was recovering.
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| 65 | 2021-03-18 | joint pain | Fever, headache, chills, joint pain, gas, diareah, loss of appetite, anger |
| 65 | 2021-03-18 | muscle tightness |
Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face a...
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Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; Rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck.; This is a spontaneous report from a contactable Nurse. This 65-year-old female Nurse (patient) reported that she started to receive bnt162b2 (BNT162B2, Solution for injection, Lot# EL9265), via an unspecified route of administration from 29Jan2021 10:30 to 29Jan2021 10:30 at SINGLE DOSE for COVID-19 immunisation. Medical history included allergy to venom from an unknown date and unknown if ongoing. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), calcium (CALCIUM), lisinopril (LISINOPRIL), omeprazole (PRILOSEC [OMEPRAZOLE]). On 29Jan2021 10:45 the patient experienced rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck (pruritus), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck (rash), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck, rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (swelling face), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (muscle tightness). The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as recovering. Therapeutic measures were taken as a result of rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (pruritus), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (rash), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (rash), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (swelling face), rash on face and neck, swelling in cheeks, tightness on left side of neck, and itching in the face and neck. (muscle tightness).
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| 65 | 2021-03-18 | muscle tightness | Dizziness, nausea, blurred vision, elevated blood pressure, tightness in neck muscles |
| 65 | 2021-03-18 | muscular weakness |
Blurry vision, difficulty with memory, nausea, brain fog, weakness right hand, weakness both legs...
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Blurry vision, difficulty with memory, nausea, brain fog, weakness right hand, weakness both legs, pis and needles sensation toes, slight headache, sore arm
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| 65 | 2021-03-18 | muscle pain, joint pain | Injection site soreness Extremely tired Headache Low grade fever Muscle and joint pain |
| 65 | 2021-03-19 | armpit pain |
Noticed my left armpit was slightly swollen a few hours after getting 2nd vaccine. I woke up the nex...
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Noticed my left armpit was slightly swollen a few hours after getting 2nd vaccine. I woke up the next day and it is visibly swollen and uncomfortable. Took Advil before bedtime but no change noted.
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| 65 | 2021-03-19 | muscle pain |
Flulike symptoms (fever, muscle aches, headache) beginning 16 hours after vaccine and lasting 14 mis...
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Flulike symptoms (fever, muscle aches, headache) beginning 16 hours after vaccine and lasting 14 miserable hours
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| 65 | 2021-03-20 | joint pain, neck pain, muscle pain |
Site pain. - Tiredness. - Left sided posterior neck pain with headache that was also left sided. T...
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Site pain. - Tiredness. - Left sided posterior neck pain with headache that was also left sided. Through the night then experienced the following: Muscle and joint pain, in shoulders and collar bone, elbows, hands and fingers. Hips, legs, and extreme hot feeling in knees with an extreme throbbing pain that lasted briefly. Then same hot throbbing pain in soles of feet, briefly. This followed by sharp stabbing pain in right heel, that also was a brief passing sensation. The following day, used Tylenol for headache. Felt extremely cold, especially hands. Continued with knee and ankle soreness. By mid day on 3/21. Felt more normal.
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| 65 | 2021-03-20 | musculoskeletal discomfort, muscular weakness |
Day 3 post vaccine (3/10/21)began with tingling of lower lip and full sensation, red rash neck, uppe...
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Day 3 post vaccine (3/10/21)began with tingling of lower lip and full sensation, red rash neck, upper chest,back and thighs. Seen by PCP and communicated with my rheumatologist . By next day upper lip felt tingly and full Dri increased my daily medrol to 8 mg .as throat felt tight . Noted next day mucoid eruptions on upper lips ,palate. Enlarged bilateral axillary lymph nodes. Rash dissipated by 3/14/21. Still have tight right throat feeling. Still on 6 mg medrol. Still have left shoulder and clavicular discomfort, intermittent tingling both hands and right leg, muscular weakness and fatigue.
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| 65 | 2021-03-20 | muscle pain, joint pain |
March11,12,13 injection site pain /March14 -21 tiredness,severe headache,muscle pain chills, joint p...
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March11,12,13 injection site pain /March14 -21 tiredness,severe headache,muscle pain chills, joint pain, fever,nausea, feeling unwell
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| 65 | 2021-03-21 | armpit pain, joint pain, neck pain |
delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and nec...
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delirium; Bone freezing chills; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain; left arm, shoulder and neck intense pain/soreness in neck; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; soreness in neck and armpits; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm, on 03Mar2021 09:15, at a single dose, for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took codeine and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) administered on the left arm on 10Feb2021 09:15 for covid-19 immunization at the age of 65-years-old. The patient did not receive other vaccines in four weeks and did not have other medications in two weeks. The patient did not have covid prior vaccination. The patient experienced the following adverse events on 03Mar2021 at 18:00 - bone freezing chills; delirium; left arm, shoulder and neck intense pain; debilitating headache; pounding heart; feeling like body will explode from inside out; unable to get up; nausea; continued soreness in neck and armpits and; headache for 3 days. The patient recovered from headache on 06Mar2021 18:00. The patient recovered from all the other remaining adverse events on Mar2021. The patient took ibuprofen as treatment for all the reported adverse events. The patient was not covid-tested post-vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
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| 65 | 2021-03-22 | joint pain |
Pt notes that her BG levels started to rise about 5 days after the vaccination and remained elevated...
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Pt notes that her BG levels started to rise about 5 days after the vaccination and remained elevated for a little over a month later. Her BG readings have been improved since then. She also noted to worsening depression, fatigue, arthralgias associated beyond the initial period of the vaccination.
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| 65 | 2021-03-22 | armpit pain |
Under my right arm(armpit) is very sore, it?s sore to touch with a little swelling, I had the inject...
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Under my right arm(armpit) is very sore, it?s sore to touch with a little swelling, I had the injection on Saturday and I woke up this way on Sunday morning
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| 65 | 2021-03-22 | muscle tightness |
Immediately after receiving the vaccine she experienced a very strong, pungent and sharp taste and s...
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Immediately after receiving the vaccine she experienced a very strong, pungent and sharp taste and smell, which passed within 5 minutes. In those 5 minutes the next thing was tingling in her face, cheeks, lips and her sinuses which were not clogged up at the time cleared, which stayed that way until Saturday morning. She did have tingling and numbness in her fingers, but nothing in her feet, and did not extend beyond her face and cheeks. Then 20 minutes later at 1:55 PM her tongue became sort of thick and a little numb, but did not swell. The area between her tongue and mouth tightened and her jaw tightened but nothing swelled. No itching in the throat. She had some sort of aching like menstrual cramps but has had a hysterectomy. She did also have a headache, took a Tylenol at 2:15 and went to sleep. When she woke up had fatigue, sore arm, and everything else had passed other than the lips feeling prickly and numb. The tongue was no longer tight or in the jaw. Just still had the open sinuses and the headache. The most significant thing was the thickness and lack of feeling of her tongue. By Saturday she was fine other than the normal side effects, soreness of arm, no red rash, but had been moving it around.
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| 65 | 2021-03-22 | neck pain, joint pain |
Started with severe headache, moved to base of skull and neck. Next day (Thurs. 3/18) extreme pain i...
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Started with severe headache, moved to base of skull and neck. Next day (Thurs. 3/18) extreme pain in neck, chest and shoulder area, headache, chills, fatigue, shortness of breath, heart palpitations, brain fog, malaise. I thought it would pass. Friday I felt no better - by evening I felt swelling in my neck and chest area. Noticeable swelling in clavicle area on both sides. Saturday & Sunday I rode it out until I could see my Dr. on Monday March 22. Dr. gave me a shot of steroids and a script for MethylPREDNISolone - 21 tablets. Today is Tuesday, March 23, 2021 and I feel much, much better. Dr. said to NOT get the 2nd shot and to report this reaction.
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| 65 | 2021-03-22 | neck pain |
Left side neck pain, from jawline to collarbone, with some swelling where most pain located, on lowe...
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Left side neck pain, from jawline to collarbone, with some swelling where most pain located, on lower left area of neck, from side to left front (muscle or lymph node behind muscle) Treated with cold compress, prescription Ibuprofen and Baclofen. after seen by Urgent Care doctor today.
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| 65 | 2021-03-23 | muscular weakness |
Friday @ 1am started throwing up and could not stop for 7 hrs. Very Nauseous through Sat and part o...
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Friday @ 1am started throwing up and could not stop for 7 hrs. Very Nauseous through Sat and part of Sunday . Had hot and cold chills through Sunday. Legs and arms were feeling fatigue. Started eating again by Monday afternoon. Tues just arms and legs feeling like wet noodles. Today Wednesday feeling 50% better then day before.
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| 65 | 2021-03-23 | muscle pain, joint pain | 24 hours of fever between 100 and 101, muscle ache, joint pain, fatigue |
| 65 | 2021-03-23 | neck pain, spinal pain |
Reports soreness in her arm, spinal column and neck. She said her neck is still not ?right? followin...
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Reports soreness in her arm, spinal column and neck. She said her neck is still not ?right? following her vaccine
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| 65 | 2021-03-24 | joint pain, muscle pain | Fever, Chills, Headache and joint and muscle pain. Fatigue. 48 hours. Resolved. |
| 65 | 2021-03-24 | joint pain |
Started about 3am Saturday Morning March 6 with extreme pain between shoulder blades. Took 2 Advil a...
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Started about 3am Saturday Morning March 6 with extreme pain between shoulder blades. Took 2 Advil and was able to go back to sleep. Woke in the morning feeling fine. Then started becoming ill early afternoon. Fever every day for 2 weeks. Nausea, vomiting, lose of appetite, extreme fatigue, headache, light sensitivity, rash, nagging slight cough and some nasal stuffiness mostly when talking (this might be because of the pollen) We were told it was an unidentified virus that would have to "run its course". Even though we are vaccinated, we continue to quarantine because we provide child care for my grandson. There was virtually no circumstance where I would have been exposed to a virus. Also, my husband had to care for me because I could do almost nothing for myself and he did not contract the virus.
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| 65 | 2021-03-24 | facial discomfort |
(note I had half the dose in each arm because my first shot had caused reactions of rash, lightheadn...
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(note I had half the dose in each arm because my first shot had caused reactions of rash, lightheadness and swelling tongue). This time I am having more effects. Immediately I had blurred vision in my right eye and facial muscle tightening. Upon arriving home I became severely fatigued and and still am 24 hours later. As of 16 hours later I developed severe pain in the right arm only, body aches, loss of taste and various facial tightening sensations and swelling tongue (I took Zyrtec for the latter and that helps). NO anaphylaxis. THese may go away in the next day or so but that is as yet unknown.
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| 65 | 2021-03-24 | muscle pain, muscular weakness | Vomiting, nausea, headache, muscle aches and muscle weakness, chills for several days after vaccine |
| 65 | 2021-03-24 | neck pain, joint pain |
On-set on dizziness, severe pain and swelling in left arm. 6 hour later, severe pain shooting up my ...
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On-set on dizziness, severe pain and swelling in left arm. 6 hour later, severe pain shooting up my arm, radiating up my neck to my left ear. Severe pain on left side of chest, left breast and pain radiating over shoulder to back on left side. On scale of 1-10, the pain was a 9. Extreme heaviness on both sides of chest. I could breath but seemed difficult to take deep breaths. Took an extra dose of my blood pressure meds and it eased the pain to a 4-5 and I was finally able to sleep at 1:00 AM. Starting on March 8, 2021 I began having severe night sweats and continue to have them at present (March 25, 2021). Dr does not recommend that I take the second vaccination due to my reaction to the first one. He did recommend that I take the Johnson & Johnson but the health department is stating that I have to complete my vaccinations with the same on I started with. I will not have the second Pfizer.
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| 65 | 2021-03-25 | armpit pain |
On March 19 around 8 pm my lymph nodes under my arm started swelling and were very painful. They st...
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On March 19 around 8 pm my lymph nodes under my arm started swelling and were very painful. They stayed like that for for 3 days before starting to go down.. The injection hurt when it was given. The first dose given in my left arm did not hurt 2/22/202. My lymph nodes in my neck swelled a little, but never caused pain. I had a mammogram on 3/18 and a place on my left breast/ lymph node has shown that it could be malignant , but I have to go for more tests to check it out. I have since read about this happening after the Covid 19 vaccine. The nurses at hospital said to report things like this since the vaccine is still so new, to help know what is happening. So that?s why wam. Thank you!
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| 65 | 2021-03-25 | armpit pain |
Mar 24, 2021 very slight soreness, spose noted burgundy, swollen area R deltoid site. assoc with sli...
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Mar 24, 2021 very slight soreness, spose noted burgundy, swollen area R deltoid site. assoc with slight h/a, very slightly swollen glands in posterior neck. March 25, 2021 warm to touch, increased size and soreness at site 69.85mm x 76.2mm, swelling with no discoloration 95.25mm with and slight soreness axillary nodes. March 26, 2021 No change size, hot to touch, uncomfortable, less red, itchy entire pink area.
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| 65 | 2021-03-25 | armpit pain |
103.9 fever, excruciating headache, lymph nodes under both arms swollen and hurt, fatigue, hurt all ...
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103.9 fever, excruciating headache, lymph nodes under both arms swollen and hurt, fatigue, hurt all over my body, nausea, injection site sore
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| 65 | 2021-03-26 | neck pain |
Had slight headache and pain in back of neck on 26, assumed back of head was sinus, tool Sudafed, ha...
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Had slight headache and pain in back of neck on 26, assumed back of head was sinus, tool Sudafed, had taken acetaminophen about every 12 hours since evening of 25th,. Woke in the night of 26 which was early am of 27 with collarbone on right side hurting with a knot on it about the size of a nickel. Around 8 am on 27 th it seemed to spreading down and up into my neck, slight pain, more like an ache. Called Er in hospital told I could come to the emergency room if I thought I needed to, couldn?t give any advice on the phone but gave me this site.
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| 65 | 2021-03-29 | armpit pain |
Huge painful lump in left armpit. Maybe 2 inches in diameter on the morning of the 4th day. Easily v...
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Huge painful lump in left armpit. Maybe 2 inches in diameter on the morning of the 4th day. Easily visible in a mirror. Not 100% certain of the letters in the lot number, but numbers are correct.
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| 65 | 2021-03-29 | muscle pain |
TWO DAYS AFTER THE VACCINE I HAD A SEVERE BURNING PAIN AT THE FRONT OF LEGS FROM THE KNEE TO THE HEA...
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TWO DAYS AFTER THE VACCINE I HAD A SEVERE BURNING PAIN AT THE FRONT OF LEGS FROM THE KNEE TO THE HEAL.NEXT DAY MY WHOLE BODY WAS ACHING AND SOAR MUSCLES. CALLED DR SAID I WAS HAVING A BAD REACTION TO THE VACCINE, HE SAID ALSO ITS LIKE A FLU SYMPTOMS. IT LASTED 11 DAYS AND I AM STILL NOT WELL, VERY TIRED AND NO ENERGY . I AM TAKING TYLANOL, GABAPENTIN, MOTRIN JUST TO KEEP THE NERVE PAIN AT EASE
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| 65 | 2021-03-29 | muscle pain |
Vertigo and muscle aches both legs especially thighs muscles and feet muscles. The aches started abo...
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Vertigo and muscle aches both legs especially thighs muscles and feet muscles. The aches started about three days after the first vaccine. I woke up with a bad case of vertigo and it took about a minute to find my balance. After about an hour, the sense of spinning went away. But I then noticed that my leg muscles were aching. The aching continued for four days. The pain was never bad enough for me to seek medical attention. I notice today on March 30 that the muscle aches are gone.
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| 65 | 2021-03-30 | joint pain |
12/29/2020 vaccination About 2 weeks later, I woke up with both of my hands and wrists hurting .It w...
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12/29/2020 vaccination About 2 weeks later, I woke up with both of my hands and wrists hurting .It was to the point where I could barely hold a pen in my hand. No swelling nor redness. It went away after 1-2 days. It came back a couple of days later; more predominantly in my right hand. I would take 600 mg Ibuprofen. The following week, it came back and lasted longer then a day; redness and swelling R hand. I called my Dr. She ordered all this lab work; came back Neg. Meloxicam It went away on R wrist. Came back on my left knee; went away. Then had pain in my L hand joints; no outside welling nor redness. I took the Meloxicam again. I didn't notify the Dr of the knee pain as my lab work was all negative. The symptoms were for 2-3 weeks. I only too the Meloxicam until pain subsided; not continuous.
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| 65 | 2021-03-30 | joint pain |
Extremely sore joints, particularly shoulder; Profound fatigue; This is a spontaneous report from a ...
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Extremely sore joints, particularly shoulder; Profound fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received first dose bnt162b2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 14:00 (Batch/Lot Number: EN5318) as single dose for covid-19 immunisation. Medical history included allergies extensive. Concomitant medication included thyroid, metformin and celecoxib (CELEBREX). The patient experienced on 11Feb2021 07:00 Extremely sore joints, particularly shoulder. Profound fatigue. The outcome of the events unknown.
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| 65 | 2021-03-30 | joint pain |
hallucination; stomach had been getting harder all day long; severe diarrhea; numbness in her hand/n...
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hallucination; stomach had been getting harder all day long; severe diarrhea; numbness in her hand/numbness in her feet up to her knees; little blue squares vibrating and pulsating on her wrists to her finger tips; Severe pain in her right hip; she was ready to pass out; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302) via an unspecified route of administration, administered into the left arm on 06Mar2021 09:45 as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome. There were no concomitant medications. On 07Mar2021 at 17:30 patient's stomach had been getting harder all day long, she had severe diarrhea and when she was in the toilet she noticed numbness in her hand, numbness in her feet up to her knees, severe pain in her right hip. She also saw little blue squares vibrating and pulsating on her wrists to her finger tips, she was ready to pass out and thought that she might be having hallucination (AS REPORTED). She was trying to lift her hip off the toilet and just wanted to get to the floor to curl up in the fetal position. Then suddenly all these effects went away and she was fine the rest of the night and has been fine ever since. The patient was asking if these could be side effects of the vaccine or if it was just a part of her IBS. Outcome of events recovered on 07Mar2021.
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| 65 | 2021-03-31 | joint pain, musculoskeletal stiffness | Fatigue, body stiffness and joint pain |
| 65 | 2021-03-31 | arthritis, joint pain |
Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every ni...
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Nausea; Vomiting; Feeling unwell; Severe fatigue/Fatigue extreme; she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day; like she had arthritis; Her hair has been falling out/Hair loss; Joint pain; Fingers were frozen; Couldn't eat; barely hydrated; Pain she had in her fingers/ Her toes hurt when she walks; It was hard for her to cook, wash clothes, and do anything; This is a spontaneous report from a contactable Nurse (Patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2, intramuscular, administered in Deltoid Left on 16Feb2021, 13:15 (Batch/Lot Number: elg267) as SINGLE DOSE for covid-19 immunisation, at 65 years old. Medical history included ongoing Irritable bowel syndrome, she was diagnosed with IBS (irritable bowel syndrome) 15 years ago (unspecified date); Blood pressure high from 2000 and ongoing, High cholesterol from an unknown date (she has had high cholesterol for about 4-5 years or longer), depression from an unknown date (she was diagnosed with depression in her 30s after a car accident. She said she has had post-traumatic stress and depression for years); type 2 diabetes mellitus from an unknown date (she has had Type 2 Diabetes for a while. She said she couldn't take the diabetes medicine. She said she didn't say much to her doctor about the diabetes medicine. She said she tried all different medicines for her diabetes. She said her current doctor had been treating her Type 2 Diabetes for almost 4 years now); post-traumatic stress from an unknown date. Patient received the first dose of BNT162B2 on 29Jan2021 13:15, 65 years old, (lot number el9262) for covid-19 immunisation and experienced back pain, fatigue, alopecia, malaise, arthralgia, nausea, vomiting, feeling abnormal, musculoskeletal stiffness, arthritis, illness, hypersomnia and fluid intake reduced. There were no concomitant medications. The patient had her second COVID-19 vaccine on 23Feb2021. On 23Feb2021, patient experienced feeling unwell. She has never been so sick; and severe fatigue/fatigue extreme. She got her second COVID-19 Vaccine shot her tiredness was worse. Reported with the regular flu vaccine she had felt bad for maybe 3-4 days, but nothing like how she felt after getting the COVID-19 Vaccine. Reported after she received her second COVID-19 Vaccine on 23Feb2021, she didn't feel good. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. Reported it had been 10-12 days since she had her second COVID-19 Vaccine, and she was still so tired. She is tired all of the time. Her tiredness was worse. She was tired and went to bed. She said the next morning she was tired, and then the next day she was really tired. She said the following day got so bad; she was in bed for 2 weeks. She said she only got out of bed to go to the bathroom and get something to drink and a few crackers to nibble on. She said she had such severe fatigue that she goes to bed at 6:30PM every night and wakes up at 9:00AM the next day. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. She said she had gone to her doctor yesterday and was exhausted when she got home. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed. She said she woke up at 5:30AM today. She said she was exhausted from just going to a doctor's appointment. On 25Feb2021, patient experienced nausea and vomiting. She said she had severe nausea and vomiting, clarifying that the nausea and vomiting lasted 2 weeks. Treatment was Phenergan Syrup 6.25mg/5ml every 6 hours, as needed. She said the Phenergan was originally prescribed for IBS. She said the Phenergan Syrup was dispensed in a pharmacy bottle, and didn't have a NDC, Lot, and Expiration Date. She said the Phenergan prescription label only had a printed barcode. Zofran 4mg tablet, as needed, three times a day. On an unspecified date in Feb2021, the patient experienced her hair has been falling out / Hair loss. She reported that her symptoms while a little better she is still tired all of the time, her hair is still falling out reporting, "If I roll it up in a clump its the size of a golf ball". She said after she got her second COVID-19 Vaccine on 23Feb2021, her hair loss was really bad. Hair Loss Treatment: She said the first thing she started taking was 1 Vitafusion Extra Strength Biotin 5000mcg Hair, Skin, and Nails Support. She stated she also took 2 Vitafusion Vitamin C 282mg Gummies a day. She said the product label said to take 3 Vitafusion Vitamin C 282mg Gummies per day, but she only takes 2 Gummies; Reported she was taking a multivitamin with Biotin and antioxidants every day. She said her doctor knew she was taking more than one vitamin and supplement and told her to watch out because she may be taking more than what was recommended. She said she stopped taking the multivitamin and now takes a regular vitamin. She said she also takes D3. She said her Fingers were frozen in a half closed position when she woke up in the morning. She said she had to work to open her fingers up. She said her fingers were sore, and she had to massage her fingers to get her fingers to unstick; Couldn't eat and was barely hydrated. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed; Pain she had in her fingers/ Her toes hurt when she walks, she never hand been like this before. She said every joint in her body ached like she had arthritis. She said her toes, ankles, knees, fingers, and arms ached. She said she still has the joint pain happening. She said her fingers were sore. Treatment: Reported when she was at her doctor appointment yesterday, she asked her doctor for a Prednisone prescription for her joint pain. She said her doctor gave her a 6 day prescription of Prednisone 50mg tablets. She said she was dispensed 6 Prednisone 50mg tablets and is to take 1 Prednisone 50mg tablet a day for 6 days; It was hard for her to cook, ash clothes, and do anything. She said she was just laying bed with an ice pack, or a heat pack, and taking pain pills. She said she told her doctor she had called the Health Department, and the CDC. She said the Health Department didn't want to tell her anything, and the CDC will only talk with someone who has had an anaphylactic reaction to the COVID-19 Vaccine. She said she asked her doctor how long she was going to have the side effects. She said her doctor said that all of her patients who had any reaction to the COVID-19 Vaccine, had mostly had called into her office to ask about the COVID-19 Vaccine side effects, and most of the patients COVID-19 Vaccine side effects resolved in a week. She said her doctor said not one of her other patients had ever told her about the kind of side effects she was having. She said her doctor told her she must be in the 2% group and to call Pfizer to report her side effects. She asked how long the events would last and what can she take. The patient underwent lab tests and procedures which included cardiac stress test: all was good right now (unspecified date). Therapeutic measures were taken as a result of her hair has been falling out/hair loss, like she had arthritis, nausea, vomiting, joint pain (arthralgia). Events did not require visit to emergency room. Outcome of the event hair loss was not recovered; outcome of feeling unwell, severe fatigue/exhausted, joint pain was recovering; nausea and vomiting was recovered on an unspecified date; and outcome of all other events was unknown. The patient considered the events as related. The reporter considered the events as serious - medically significant.; Sender's Comments: Based on a temporal association and known drug safety profile, the causal association between the events and the suspect drug BNT162B2 cannot be totally excluded. Possible contribution from patient's underlying medical condition is also considered. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.
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| 65 | 2021-03-31 | joint swelling | Rash on face hands elbows and knees are so swollen |
| 65 | 2021-03-31 | neck pain, joint pain, back pain, musculoskeletal pain |
Shoulder, back, neck aches Feeling out of sorts Trouble sleeping slight runny nose (left nostril) Oc...
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Shoulder, back, neck aches Feeling out of sorts Trouble sleeping slight runny nose (left nostril) Occasionally pinch pain (left arm and shoulder) Cold sore (left nostril - same side of injection) Pain in right buttock
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| 65 | 2021-04-01 | joint pain, muscle tightness, muscle fatigue |
She got the vaccine, and felt right away a wave of nausea that passed quickly. She felt like she wa...
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She got the vaccine, and felt right away a wave of nausea that passed quickly. She felt like she was going to have to throw up. Then she came home, she lives about 5 minutes away, came in the door and right away she did not feel well, like she was coming down with the flu. She felt tired, weak, started to feel great muscle fatigue, followed by muscle tightening, joint pain in her knees, ankles, shoulders, back, neck, as well as headache (not real bad, manageable with Tylenol). No fever, but does have chills. She would say the biggest problem is the fatigue. She has been taking Tylenol for the symptoms. She has not called the doctor. She is also light headed and has a little shortness of breath, but knows she has to lie down to get more rest before she can proceed to do anything else. She also has had quite a bit of pain in the arm, but she managed that with a cold compress on it.
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| 65 | 2021-04-01 | back pain, joint pain, musculoskeletal stiffness, arthritis |
Nausea; Vomiting; Feeling unwell; severe pain in all my joints, toes, ankles, knees and my arms shou...
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Nausea; Vomiting; Feeling unwell; severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers; didn't feel good; her fingers were frozen in a half closed position when she woke up in the morning; her body ached like she had arthritis; she couldn't eat and was barely hydrated; Hair loss; she couldn't eat and was barely hydrated; Tiredness/Fatigue extreme; Backache; "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning; sick; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: el9262, Expiration Date: Unknown) via intramuscular route of administration in left deltoid on 29Jan2021 (at the age of 65-year-old) at 13:15 as a single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown, Expiration date: Unknown) via an unspecified route of administration on 23Feb2021 as a single dose, both the doses for COVID-19 immunization. The patient medical history included Irritable bowel syndrome diagnosed 15 years ago (ongoing), ongoing Blood pressure high from an unknown date in 2000, high cholesterol for about 4-5 years or longer, depression (diagnosed in her 30s after a car accident), Type 2 diabetes mellitus (she couldn't take the diabetes medicine. She said she tried all different medicines for her diabetes. She said her current doctor had been treating her Type 2 Diabetes for almost 4 years now), post-traumatic stress, she was bedridden for 2 weeks on an unknown date in feb2021 (only able to get up to go to the bathroom), it was hard for her to cook, wash clothes, and do anything on an unknown date in Feb2021. The patient underwent stress tests, and all was good right now. The patient did not receive any additional vaccines administered on same date of the Pfizer Suspect was none. The concomitant medication was not reported. The patient previously took historical vaccine, flu vaccine on an unknown date for immunisation and felt bad for 3-4 days. It was reported that after first dose patient has been so sick. The patient experienced back pain on 29Jan2021. She reports that starting the next day that was on 30Jan2021, she has experienced severe fatigue extreme and tiredness. She reports that her symptoms while a little better she is still tired all of the time. She reports "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning on an unknown date in Jan2021. Caller also reports, my joints are in severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers on an unknown date in Feb2021. My fingers are closed, and I can't straighten them out when I wake up". The patient put ice on her back and took pain pills and stuff. It was reported that patient had undergone back tests and result was not reported. The patient reported that she took she took Norco, or Hydrocodone/Acetaminophen 10mg/325mg. said her Norco 10mg/325mg prescription was for 1 Norco 10mg/325mg tablet every 6 hours, as needed, for pain. She said she normally would take 1 Norco 10mg/325mg tablet during the day, and another Norco 10mg/325mg tablet at bedtime. She said after her first COVID-19 Vaccine dose, she had been taking a Norco 10mg/325mg tablet every 6 hours. She said she also took a muscle relaxer, Tizanidine 4mg tablet. She said she took 1 Tizanidine 4mg tablet with the Norco 10mg/325mg tablet, three times a day. She said her backache felt like a belt across her lower back. She said when she has a backache, she gets off her feet, and puts her legs up on a pillow to take pressure off of her back. She said she rested, as well, but tried to do stuff around her house. She said she did have some tests on her back, and she had a fractured facet in her lower spine around the L1 vertebrae. She said she had to have some more tests done on her back. She said the backache she experienced after getting her COVID-19 Vaccine was not normal backache pain. It was Reported about 5-6 days after getting her first COVID-19 Vaccine, that was on an unknown date in Feb2021, her hair started falling out and the severity was explained by patient as "If I roll it up in a clump it's the size of a golf ball". She clarified she would brush her hair and would end up having hair everywhere (in her brush, on the counter, and floor). She said the day after she first noticed her hair falling out, she had even more hair fall out than normal. She said she was worried about her hair falling out and took Biotin and vitamins. She said after she got her second COVID-19 Vaccine on 23Feb2021, her hair loss was really bad. The patient took 1 vitamin Extra Strength Biotin 5000mcg Hair, Skin, and Nails Support (UPC Number: 2791700026, Lot Number: WA01802798, Expiration Date: Dec2021). She stated she also took 2 Vitamin C 282mg Gummies (UPC Number: 2791702071, Lot Number: WAO1887038, Expiration Date: Jan2022) a day. She said the product label said to take 3 Vitamin C 282mg Gummies. She stated she also takes 2 Calcium (UPC Number: 2791701951, Lot Number: YY01548358, Expiration Date: Jun2022) 500mg per day. Reported she was taking a multivitamin with Biotin and antioxidants every day. She said her doctor knew she was taking more than one vitamin and supplement and told her to watch out because she may be taking more than what was recommended. She said she stopped taking the multivitamin and now takes a regular vitamin. She said she also takes D3. Reported she was still tired. She clarified after she got her first COVID-19 Vaccine, she had felt tired for a few days with her back bothering her. She said she would get up and take her pain medicine, go to the bathroom, and get something to drink and go back to bed. She said she had felt a little better but wanted to take a nap every day. She said after she got her second COVID-19 Vaccine shot her tiredness was worse. Reported after she received her second COVID-19 Vaccine on 23Feb2021, she didn't feel good. She clarified when she got home from her second COVID-19 Vaccine she was tired and went to bed. She said the next morning she was tired, and then the next day she was really tired. She said the following day got so bad, she was in bed for 2 weeks. She said she only got out of bed to go to the bathroom and get something to drink and a few crackers to nibble on. She said her fatigue improved a little last week, but she had to take a nap after anytime she went to do something. She said she had gone to her doctor yesterday and was exhausted when she got home. She said she didn't eat anything when she got home from her doctor appointment and went straight to bed. She said she was exhausted from just going to a doctor's appointment. Reported every joint in her body ached like she had arthritis. She said her toes, ankles, knees, fingers, and arms ached. She said she still has the joint pain happening. She said her fingers were frozen in a half-closed position when she woke up in the morning. She said she had to work to open her fingers up. She said her fingers were sore, and she had to massage her fingers to get her fingers to "unstick." Reported when she was at her doctor appointment yesterday, she asked her doctor for a Prednisone prescription for her joint pain. She said her doctor gave her a 6day prescription of Prednisone 50mg tablets. She said she was dispensed 6 Prednisone 50mg tablets and was to take 1 Prednisone 50mg tablet a day for 6 days. Reported she had severe nausea and vomiting on 25Feb2021 and clarified that the nausea and vomiting lasted 2 weeks. She said she took Phenergan and Zofran around the clock. She said she couldn't eat and was barely hydrated. Zofran 4mg tablet (NDC Number: 65862-187-30, Lot Number: OND420010-A, Expiration Date: Jun2024), as needed, three times a day. She said the Zofran was dispensed in a white manufacturer's bottle. Reported she needed to have some regular blood work done. The seriousness of the events Backache, Tiredness/Fatigue extreme, Hair loss, Feeling unwell, Joint pain, Nausea and Vomiting were reported as serious (medically significant) by the reporter. The final outcome of the events Backache, Tiredness/Fatigue extreme, Hair loss was not recovered; Feeling unwell, severe pain in all my joints, toes, ankles, knees and my arms shoulders fingers, Nausea, Vomiting was recovering; didn't feel good, her fingers were frozen in a half-closed position when she woke up in the morning, her body ached like she had arthritis, she couldn't eat and was barely hydrated, sick and "I'm so tired I go to sleep at 18:30 in the evening and don't wake up until 09:00 the next morning was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product to the development of reported events cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-04-01 | neck pain, back pain, musculoskeletal chest pain |
3/24/2021 11:20am Was administered my 2nd dose of COVID vaccine. 3/24/2021 10:00pm Lightheaded, diz...
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3/24/2021 11:20am Was administered my 2nd dose of COVID vaccine. 3/24/2021 10:00pm Lightheaded, dizzy, fever, chills, severe stomachache, severe lower backache, severe head and neck pain, severe nausea, vomiting, dry heaves, chest pain, rib pain, heartburn, rash on stomach and sides, sore throat, earache, eyes aching, physical distress and agitation X 72 hours. 3/28/2021 - 3/31/2021 All of the above symptoms continue but symptoms are moderate instead of severe. 4/1/2021 All of the above symptoms are minor.
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| 65 | 2021-04-02 | muscle pain, weight decreased |
Spots on her arm; Itchy and warm to touch, red; warm to touch; red; Itchy and warm to touch, red and...
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Spots on her arm; Itchy and warm to touch, red; warm to touch; red; Itchy and warm to touch, red and swollen and she can see both areas; When she got injection it was sore; After second injection she got ill and everything/When she got injection it was sore and she got sick; When she got injection it was sore and she got sick; I am not dizzy anymore; I am not hot or weak anymore; I am not having muscle aches; I still don't have an appetite; improved my lungs; All I am is thirsty; chills and shakes; chills and shakes; I lost a low weight; Trouble getting out of bed; This is a spontaneous report from contactable consumer (patient). This consumer (patient) reported for herself that. A 66-year-old female patient of an unspecified age received second dose bnt162b2 (BNT162B2), via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history includes asthma, had it since been born obese, hypertension, pain in extremity, pyrexia, illness, dizziness, feeling hot, asthenia. There were no concomitant medications. The patient experienced spots on her arm (skin discoloration), itchy and warm to touch, red (pruritus) , warm to touch, red, itchy and warm to touch, red and swollen and she can see both areas , when she got injection it was sore, after second injection she got ill and everything/when she got injection it was sore and she got sick, when she got injection it was sore and she got sick , i am not dizzy anymore (dizziness) , i am not hot or weak anymore (asthenia), i am not having muscle aches, i still don't have an appetite, improved my lungs, all i am is thirsty, chills and shakes, chills and shakes, i lost a low weight, trouble getting out of bed. The clinical course of the events includes; both injection sites arms itchy, swollen red, warm to touch and she just noticed that today. When she got injection it was sore and she got sick and today is the first day: that she was able to move and be, feeling somewhat normal and all she was those two spots only if she touch them she do really notice them, they itch now, swollen. She reported that she got ill. Reported that, she had asthma, it since she have been born and noticed with a first shot sopped wheezing, next week only used my inhaler 2 or 3 times, and from that date to this one she can take a deep breath without coughing, without wheezing, whatever the ingredients of the vaccine were apparently they improved my lungs as well. All she was thirsty right now and drinking so much water. Two the best side effects so far she is breathing better, Two side effects that she liked was that she not hungry, do not know how long that is going to last and not having asthma attacks, and that is highly unusual, this is something that she hope is permanent, so she wanted to say thank you Pfizer for take away something that took away something that she was tired of having. she just wanted to say thank you. it is not spreading it is only where the injection sites are. warm top one is smaller and the bottom one is larger, they both red they both swollen, both itch and both warm to the touch, but as long as she keet this cloth over it she would have not pay attention. Today is the first day she have felt better since about 17th, and she not been out of the house out of the bed until today with the exception of getting the water and using a bathroom. muscles, chills and shakes, trouble getting out of bed , dizziness but she also contribute that because she had a poor health to begin with, she have not used nebulizer, she am obese she am pretty sure she lost a low weight, she don't know how much because she can tell my stomach is in and she use a bathroom so much so she know that she lost something, maybe 4-5 lb. but not a lot. she don't have appetite still but she am going to force myself to eat something. She mentioned that, one more time that she was obese, asthmatic and had a high blood pressure. The patient underwent lab tests and procedures which included body temperature: 96.4 on 22Mar2021. The outcome for the events was spots on her arm was not recovered and the outcome for the events i am not dizzy anymore, i am not hot or weak anymore, i am not having muscle aches, i still don't have an appetite, all i am is thirsty were recovered and itchy and warm to touch, red and outcome for the events itchy and warm to touch, red and swollen and she can see both areas , when she got injection it was sore , after second injection she got ill and everything/when she got injection it was sore and she got sick, chills and shakes, i lost a low weight was unknown. Information on the lot/batch number has been requested.
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| 65 | 2021-04-02 | muscle pain | I experienced vaginal bleeding and headache...muscle aches |
| 65 | 2021-04-03 | joint pain | Low grade fever, swelling and pain at injection site, joint pain, fatigue for approximately 24 hrs |
| 65 | 2021-04-03 | muscle pain |
Shot #1 - severe headache, chills, nausea vomiting, muscle aches pains all over lasted 24 hours I ha...
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Shot #1 - severe headache, chills, nausea vomiting, muscle aches pains all over lasted 24 hours I had a headache everyday up until lady week, I now get a headache 3-4 times a week. I also have extreme fatigue, I go to bed 6-7 pm every day. I have had a rapid heartbeat 90-115 & higher with any exertion e.g. climbing stairs, walking .. Shot #2 - massive headache... fatigued
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| 65 | 2021-04-04 | limb discomfort, neck pain, muscle pain, bone pain |
The pt had her first Covid vaccine on 3/28 in the left deltoid. Within a couple hours, she began to...
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The pt had her first Covid vaccine on 3/28 in the left deltoid. Within a couple hours, she began to have pain pain in the inner upper left arm, and then later migratory pains that traveled up her legs, across her lower abdominal surgical scar. She had chills, and fever symptoms. She developed marked myalgias. She has photophobia at baseline after her breast cancer chemotherapy, the photophobia is unchanged. She has chronic neck pain, and she came in wearing a soft cervical collar, but the neck pain is not new. No known Covid exposure. She first denied chest pain, but then she pointed to her central sternum and said that she had "bone pain" in the central chest. She also describes her migratory pain frequently calling it "red" pain. She denied abdominal pain, but she had a deep central pain deep inside her torso. Husband was interviewed and he stated that she was in good health before the vaccine. He did not note the "pale, fatigued, run down" complaint that she reported. She had the Pfizer vaccine #1 around 1130 hours. She then began to complain of a discomfort left upper inner arm. Sunday, 3/28, she began to take advid, first 400mg, then advancing to 800 mg q 4 h, and use of a hot water bottle. She then began to have the "searing pain" first in the areas where she's had surgery, both breasts and her lower abdomen. They talked to a RN on 3/30, and then to a tele-MD yesterday when her symptoms worsened, who Rx'd Vicodin. The husband (and pt) states that the pt gets an upset stomach and "muddled head" when she takes tylenol, and they didn't know that Vicodin had tylenol in it. Very soon after taking the Vicodin, she began to feel upset stomach and muddled head. She took two doses of the Vicodin, last dose yesterday. They spoke with a different tele-MD today, who called in a oxycodone 5mg tab for her, which she took at 1130 hrs and 1500 hours. Covid Symptom screen ?Cough YES, chronic, no change ?Fever (subjective or >100.4°F/38°C) YES ?Myalgia YES ?Headache YES ?Dyspnea YES, "sometimes" ?Sore throat NO ?Diarrhea NO ?Nausea/vomiting YES/YES ?Loss of smell or taste NO , abdominal pain "NO" (pt feels like she is having some discomfort "deep inside" her torso), and rhinorrhea NO
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| 65 | 2021-04-04 | muscle pain |
awakened at 3:30AM with chills. Freezing cold intensified such that I was not just shivering but sh...
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awakened at 3:30AM with chills. Freezing cold intensified such that I was not just shivering but shaking even though I had a heating pad and several quilts on me. Splitting headache started by 7AM, muscle aches and nausea; extreme fatigue. Chills changed to fever around 9AM. My husband called the nurse at Hospital who said I could come in if my temp was above 100. My temp was 102.3 at peak and broke before midnight on 4/3. On 4/4 the symptoms began to ease. On 4/5 the symptoms still easing...
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| 65 | 2021-04-07 | muscle pain, joint pain |
Not feeling well; legs were restless from hips down; fatigue; sore achy body; aching joints and musc...
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Not feeling well; legs were restless from hips down; fatigue; sore achy body; aching joints and muscles throughout body; aching joints and muscles throughout body; Chills; felt "heavy & on-fire" though cool to the touch (neuropathy); diarrhea; Headache; lower GI distress; muscle cramping all over body; Low-grade fever/temperature 100.9; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included osteoarthritis and upper gastrointestinal (GI) distress. Concomitant medications included omeprazole (PRILOSEC) taken for upper gastrointestinal (GI) distress, start and stop date were not reported; celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12) taken for an unspecified indication, start and stop date were not reported; calcium carbonate (CAL) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (lot number: EL3249) on 27Jan2021 04:30 PM at left arm. Other vaccine in four weeks reported as no. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Allergies to medications, food, or other products reported as no. These symptoms persisted for 24hours: on 18Mar2021 the patient was awoke midnight with chills, severe lower GI distress, diarrhea, head ache, muscle cramping all over body, legs felt heavy and on-fire though cool to the touch; temperature 100.9. Second 24 hours: the patient had low-grade fever, diarrhea, head ache, aching joints and muscles throughout body, continued lower GI distress. After 48 hours: the patient had temperature normal, sore achy body, head ache, fatigue. Consumed only water during first 72 hours then resumed liquids (broth, ginger ale) intake. Effectively treated diarrhea with loperamide hydrochloride (IMMODIUM); dicycloverine hydrochloride (BENTYL) for lower GI distress; resumed omeprazole (PRILOSEC) for upper GI distress. The patient returned to work on 23Mar2021 half-day, 24Mar2021 full-day still not feeling well. On 24Mar2021 during the night, legs were restless from hips down, felt "heavy and on-fire" though cool to the touch (Neuropathy) was similar to first night on 18Mar2021. On 26Mar2021, all symptoms have disappeared and the patient felt good, again she was in very good general health, active, appropriate weight, never ill. Events reported as non-serious. Events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event fever was recovered on 20Mar2021, of other events was recovered on 26Mar2021.
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| 65 | 2021-04-10 | muscular weakness, joint pain |
12 hours after receiving 1st vaccine I awoke with severe shoulder pain in both shoulders, worse in r...
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12 hours after receiving 1st vaccine I awoke with severe shoulder pain in both shoulders, worse in right shoulder (opposite from vaccine arm), very limited mobility in arms. Also pain in most other joints and muscle weakness. The situation is ongoing, some days are slightly better some are worse. Knees, shoulders and right hand are most afflicted. Pain is non-stop. Muscle weakness has grown worse. Having an extremely difficult time filling this form.
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| 65 | 2021-04-15 | musculoskeletal stiffness |
About a week after my first shot, the middle joint of my fifth finger on my left had became sore, es...
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About a week after my first shot, the middle joint of my fifth finger on my left had became sore, especially upon touch. It also stiffined. About a week after my second shot, the middle joint of my fourth finger became sore, especially upon pressure and is somewhat stiff. I have no history of any type of arthritis nor is it in my family. I had no problems with my fingers on either hand prior to the vaccinations. I play piano and never had any pains nor stiffness.
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| 65 | 2021-04-26 | muscle pain |
tingle in lips; dry mouth; swallowing differences; slight fever; headaches; tried; muscle aches; Thi...
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tingle in lips; dry mouth; swallowing differences; slight fever; headaches; tried; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 65 Years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6203), via an unspecified route of administration in left arm on 28Feb2021 at 10:00 AM at single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: (ID) 9809), via an unspecified route of administration in left arm on 07Feb2021 at 10:00 AM at single dose for COVID-19 immunisation and experienced head rush immediately after injection, extremely sore arm from first dose. Medical history included COVID 19 and allergic to flagyl, ciprofloxacin. The patient did not received other vaccine in four weeks. The patient did not tested for covid tested post vaccination. Concomitant medications included amlodipine besilate at 2.5 mg, metformin hydrochloride (METFORMIN ER) at 500 mg. On 28Feb2021 at 10:15 PM, the patient experienced tingle in lips, dry mouth, swallowing differences, slight fever, headaches, tried, muscle aches. No treatment was received. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 65 | 2021-04-26 | neck pain, joint swelling | Severe swelling in both arms and knees. Pain in back of neck into both arms and hands. Headache |
| 65 | 2021-04-30 | musculoskeletal chest pain |
coughing up blood; Coughing; Nausea; Headache; extreme fatigue; acute pain on the left side, she tho...
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coughing up blood; Coughing; Nausea; Headache; extreme fatigue; acute pain on the left side, she thought she cracked her rib/ rib pain; acute pain on the left side, she thought she cracked her rib/ rib pain; didn't sleep at all; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8757) at the age of 65-year-old, via an unspecified route of administration on left arm on 31Mar2021 at 13:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. There were no additional vaccines administered on the same date and no vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took aspirin and experienced allergy which was described as deadly. She never took medications since she found that out at 16-year-old. The patient received her first shot on 31Mar2021 at a pharmacy and mentioned that she was not sick at the time of vaccination, but she had a violent reaction to it. When she received it, she didn't feel anything. People said you will get a sore arm, but she got none of that. Then in the middle of the night on Friday (02Apr2021) probably around 3:00, she woke up with acute pain on the left side, it was rib pain, she thought she cracked her rib. On the same day, she also experienced difficulty breathing, and didn't sleep at all. On Saturday morning (03Apr2021), when she woke up, she had nausea, a headache, and extreme fatigue, but wondered if the extreme fatigue was because she did not sleep. The nausea and headache went away 8 hours later, on the same day. On Sunday (04Apr2021), she was coughing and coughed up blood. When she coughed, there was blood in the mucous. She mentioned that she still has acute pain, she could not get comfortable. Her sister passed away in January and she had a 5 pm train she was supposed to catch, she was responsible for the funeral. She was thinking that if she went to a hospital, they would keep her for 24 hours, she could maybe make it to the funeral but that was questionable. By Monday (05Apr2021), the acute pain was gone, she still had a cough, there was still blood in the mucous, she has occasionally blood in the mucous. The cough has not gone away but she was getting better every day. The difficulty breathing continued until about 08Apr2021 (as reported), but she still has some shortness of breath, but nowhere near as bad. She consulted her notes and said she was at 30% on 03Apr2021 and she felt today that she was at 80% and every day she was a little better and better. She has to sleep upright, she was afraid to sleep flat, she slept in her chair, last night for 2 nights she slept upright in her bed. She probably could lay down, but she was more comfortable upright. Because she was sleeping upright, she was not fatigued, she was not sleeping well but she didn't think that has anything to do with what was going on. The events did not result in emergency room or physician office visit. She is supposed to get her second dose on 21Apr2021but she did not want to get the second shot. She asked if she could wait and get the one shot from Johnson & Johnson. She didn't know where to go anymore. The outcome of the event "acute pain on the left side, she thought she cracked her rib/ rib pain" was recovered on 05Apr2021, recovered on 03Apr2021 for "nausea" and "headache", recovered on Apr2021 for "extreme fatigue", not recovered for "didn't sleep at all", and recovering for all other events.
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| 65 | 2021-05-04 | bone pain, joint pain |
kidneys were inflamed; grade IIIa kidney failure; got a flight or fight response; lower lip was full...
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kidneys were inflamed; grade IIIa kidney failure; got a flight or fight response; lower lip was full tingling; tongue tip so irritated and a strange feeling that it was a tiny bit edematous; tongue tip so irritated and a strange feeling that it was a tiny bit edematous; mucoid eruption on her lower lip/ mucoid eruptions in her mouth, on her palate and down her throat; rash to her face, neck, chest, back, shoulders and thighs; has bright red palms and sole of her feet are bright red; it looked like Kawasaki disease; voice change; had joint pain in her left arm and could not use her left arm and her whole entire arm and hand; had left clavicle pain under the clavicle; spontaneous cough where her heart races; spontaneous cough where her heart races; felt she couldn't catch her breath; issues in her throat and neck area had something pressing around her throat; she was so tired; chest flutters; tingling in her hands and her entire body from her scalp to her soles was so irritated and prickly; may be body inflammatory response to being vaccinated; This is a spontaneous report from a contactable Nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07Mar2021 09:40 (Lot Number: EN6199) (at the age of 65 years old) as single dose (dose 1) for COVID-19 immunisation; and methylprednisolone (MEDROL), via an unspecified route of administration from an unspecified date to an unspecified date at short term increase of the Medrol dose (as reported), from unspecified date to an unspecified date at 2 mg (for four years, as reported), then from unspecified date to 10Mar2021 at 6 mg, then from 11Mar2021 to 13Mar2021 at 8 mg, then from 14Mar2021 to unspecified date at 6 mg, for Lupus. Medical history included diagnosed with asthma initially exercised induced and now it is seasonal and was diagnosed years ago (states she has not had to use her Albuterol inhaler that much now because it is seasonal but she is doing more outside and is allergic to outside things so she tends to use the inhaler more if needed), right leg paresthesia (she did have a right leg paresthesia and had that before the vaccine), autoimmune disorder, thyroid disorder and patient stated that she has lost height. Concomitant medications included salbutamol (ALBUTEROL HFA) taken for asthma; levothyroxine sodium (SYNTHROID) taken for thyroid disorder; paracetamol (TYLENOL); and diphenhydramine hydrochloride (BENADRYL). The patient had a history of Lupus and is on maintenance Medrol 2mg for four years and before that she had a short-term increase of the Medrol dose with flares of her Lupus. She had the Pfizer COVID Vaccine 1st dose and then three days later on 10Mar2021 at 16:00, she thought what is going on and had her tongue tip so irritated and a strange feeling that it was a tiny bit edematous, her lower lip was full tingling. She had mucoid eruption on her lower lip and saw then that the next day thought it was swollen but it wasn't swollen. She had eruption on her tongue, had a rash to her face, neck, chest, back, shoulders and thighs. The rash was dispersed and there is a red raised rash with Lupus called Livedo reticularis and that is usually on the thighs but this rash on her was below her thighs and came up and dispersed between all the same rash elsewhere on her body. The healthcare professionals were closed so she took increased Medrol steroids and her Albuterol inhaler and Benadryl; the Benadryl was thrown out and discarded so she has no lot number to provide for it, stated that the Benadryl was the pediatric dye free bubblegum free. The Albuterol Sulfate HFA inhaler is 90mcg per puff and she does two puffs every 6 hours as needed; she had not taken the inhaler but she has trouble with asthma and took the Albuterol inhaler now as preventative and needs to use the inhaler as of yesterday (lot Y23B with expiry date Dec2021). Patient stated that she has the tools of her Albuterol inhaler, the steroid Medrol and the Benadryl and the knowledge so she prevented the symptoms she was reporting from being life threatening but stated the reported events were a little disabling and medically significant.She had joint pain in her left arm and could not use her left arm and her whole entire arm and hand. She had left clavicle pain under the clavicle and knows this did occur in the random trials but for her it went away after two days and is now back regarding the pain. She has bright red palms and sole of her feet are bright red. The next morning on 11Mar2021, her upper lip was tingling and she did go see her healthcare professional in town and sent photos to her Rheumatologist. As time went on she had tingling in her hands and her entire body from her scalp to her soles was so irritated and prickly and her soles and palms were bright red; it looked like Kawasaki disease and she used to take care of children with Kawasaki disease. On Saturday which was the 3rd day she was on the Medrol 8mg and had the fight or flight cardiac symptom and she cut herself down on the Medrol on the next Sunday to 6mg which seemed to make her better. The redness was gone until she had the Pfizer COVID Vaccine 2nd dose yesterday and the healthcare professional initially said after her 1st dose of the vaccine to wait and see her rheumatologist do decided to do the increased Medrol dose of steroids and she stated she has got to get the 2nd dose of the Pfizer COVID Vaccine; the healthcare professional checked her lungs that were clear and her pulse ox was fine and she was not wheezing and she then went on increased steroids from Medrol 6mg to 8mg right away. She did have a right leg paresthesia and had that before the vaccine so she knows what it is like because she has issues with her spine but had not had the paresthesia in a long time. She increased to Medrol 8mg for the three days after the 1st dose of the Pfizer COVID Vaccine and got a flight or fight response. She had to increase the Medrol dose from 6mg and popped it up to 8mg and she had mucoid eruptions in her mouth, on her palate and down her throat and had a voice change. She has a laryngoscopy on Thursday (25Mar2021) with her ENT. She has pediatric doses of everything because she reacts to almost everything. The 2nd dose of the Pfizer COVID Vaccine was administered to her on 29Mar2021 09:45 with lot ER8732. Patient stated that anyone else would have gone to the emergency room but she took care of herself at home and knows the risk factors related to the vaccine. She absolutely felt the reported events were related to the Pfizer COVID Vaccine in terms of causality and she never had these issues before. The rheumatologist had experience with patients with autoimmune diseases and stated people with autoimmune disease have a heightened immune reaction to the vaccine no matter which vaccine they get and are overly active and then a vaccine is thrown in there and we are charting new territory. The next Thursday or Friday over a week now after the Pfizer COVID Vaccine she had a multisystem type of thing and on 18th and 19th of March she started having episodes and was not doing anything but quietly doing something and had chest flutters and spontaneous cough where her heart races and felt she couldn't catch her breath and is now on a 30 day event monitor. She was not sure this is due to the Medrol steroids or the Pfizer COVID Vaccine. She got her thyroid TSH level done because sometimes when the Synthroid dose needs to be lowered because it is too high for your body and you can have atrial flutter which she has had before in the past from her Synthroid dose being too high; states her Synthroid is 50mcg and takes it once per day by mouth and it is in a prescription bottle with no lot, expiry date or NDC. Patient saw her primary care physician again last Tuesday on 23Mar2021 and all the issues in her throat and neck area had something pressing around her throat and thought it was lymph nodes and woke up with a voice change and physician said he would take a look and he said it was not thrush and she would have to be scoped because he couldn't see in her throat. She had a referral for a CBC and Chemistry lab to be done on 25Mar2021 and TSH was in the usual range for her, the results from Thursday (25Mar2021) night had her BUN and creatinine and GSR (Glomerular filtration rate) abnormal. The rheumatologist called her that night and talked to the physician and said he considered this may be body inflammatory response to being vaccinated and could be that her kidneys were inflamed and she does not know as this is all new territory. For the kidney issues, the information was sent off to the rheumatologist who did orders and called the physician back the next day and she told him she thought she needed a nephrology consult and had urine chemistry, a urinalysis and looked for protein and did a blood draw for a chemistry screen with the following results on 25Mar2021: BUN 22.3, grade IIIa kidney failure, creatinine 1.28, eGSR-NAA 42ml/min, normal is over 60 and she usually runs 70 something. She went to the hospital over the years to have her chemistry lab done because she has Lupus and over the last two years she has never been below 60 for the eGSR-NAA. On 26Mar2021, she repeated the blood work and sent everything to her physician and the CMP had her BUN still elevated at 19.5, the creatinine was down to 0.97 and the eGSR-NAA was up to 58mL/min which is still abnormal; the urinalysis was all fine with no white cells and no leukocytes and no protein; the urine chemistry had the creatine of 8.5, the protein in the urine LVL was less than 0.4mg. Her CBC had her lymphs and monos down and she would expect having this response to the vaccine. Both physician called her on the weekend and they were concerned this came out of nowhere and now are monitoring her again in a month; her physician and rheumatologist both were entertaining this could be related to the Pfizer COVID Vaccine. She does not take vaccines because of what they do to the body and did take the flu vaccine in Oct2020. She was covid negative (unspecified date) and stated had to be screened on Friday 26Mar2021 before her laryngoscopy and did the PCR test and only does the PCR. States she was doing research and had conflicting information from her physician and rheumatologist who she first saw her physician, after her 1st dose of the vaccine and the rheumatologist talked about increasing her steroids and she told him she was so tired and how with increased steroids, do steroids impact the effectiveness of the covid vaccine being blunt immune suppressants. Physician said long term chronic steroids have no effect on the effectiveness of the vaccine. She has no had headaches, shaky chills like everybody else has because she is on immune suppressants and has an article that says some evidence for steroids diminishing efficacy in Pfizer COVID Vaccine. No prior vaccinations within 4 weeks. No additional Vaccines administered on same date of the Pfizer suspect. Events required a visit to physician office (No visit to the ER but did see her physician). The last action taken in response to the events for methylprednisolone was unknown. The outcome of the event had left clavicle pain under the clavicle was recovered on 12Mar2021; event has bright red palms and sole of her feet are bright red was recovered in Mar2021; outcome for the other events was unknown.; Sender's Comments: The reported events are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but possible contributory effects from patient's medical history and concomitant medications cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 65 | 2021-05-04 | facial discomfort |
it sounded like a form of Bell's Palsy; left cheek tingle; my left forehead, cheek, side of lip and ...
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it sounded like a form of Bell's Palsy; left cheek tingle; my left forehead, cheek, side of lip and chin felt like I had razor burn.; My head itched; left eye felt dry; salivate more than usual from the left side of my mouth; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; left side of my face began to feel heavy, sometimes also my sinuses, but more often my lower jaw; feel pain in my left ear; My lymph nodes on the left side of my face became swollen; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 12:45 (Batch/Lot Number: EN6202), at the age of 65-years-old, as single dose for COVID-19 immunization. Medical history included allergy to Sulfa. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included calcium; magnesium; colecalciferol, menadione (VITAMIN K+D); glutathione; all taken for an unspecified indication, start and stop date were not reported. Within 45 mins (also reported as 20-25 minutes) of receiving the shot, she began to feel her left cheek tingle. In the intervening days, her left forehead, cheek, side of lip and chin felt like she had razor burn. Her head itched. Her left eye felt dry, but that went away. She began to salivate more than usual from the left side of her mouth. The left side of her face began to feel heavy, sometimes also my sinuses, but more often my lower jaw. Sometimes, she would feel pain in her left ear. Her lymph nodes on the left side of my face became swollen. Her doctor on Zoom said it sounded like a form of Bell's Palsy (medically significant), though she does not have the drooping eye or mouth. She had an MRI of her left lymph node that did not reveal any issues. Her symptoms, while they have abated, are still present five weeks after the shot. The events started on 26Feb2021 13:30. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event left eye felt dry was recovered while other events was not recovered.
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| 65 | 2021-05-04 | muscle pain |
leg was bruised; heart spasms; Diarrhea; inflammation along the major vein in her leg; heart palpita...
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leg was bruised; heart spasms; Diarrhea; inflammation along the major vein in her leg; heart palpitation; light headed/dizzy; severe muscle pain; tenderness and soreness in her inner thigh of the left leg/throbbing pain; Chills; This is a spontaneous report from a contactable consumer (patient, self-reported). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6208), via an unspecified route of administration in unspecified arm on 09Mar2021 (12:00) at single dose for Covid-19 immunization. The patient's medical history included ongoing hypothyroidism. Concomitant medication included levothyroxine been taking for 10-11 years for hypothyroidism. On 17Mar2021, Wednesday, the patient received the vaccine and had chills. On 18Mar2021, the patient had tenderness and soreness in her inner thigh of the left leg. On 19Mar2021, the patient had severe muscle pain on her calf of leg to inner thigh and it was throbbing so bad behind her knee on her left leg that she called her physician, and a sonogram was performed on 23Mar2021 which had found there was not a blood clot but there was severe inflammation along the major vein in her leg. On 20Mar2021, the patient had heart palpitation, her doctor told her to drink water and propel, she had heart spasms for 6 hours and felt lightheaded and dizzy. she thought she would go to the hospital, but she lives in a rural community and felt it did not make sense to go to the hospital. Palpitations and tenderness recovering. Her doctor and she was put on a heart monitor for her heart palpitations. She had heart palpitations with her hypothyroid but, this was totally different when she has had heart palpitations in the past. On an unknown date in Apr2021, the patient had diarrhea for 6 days. Patient had not been back to the doctor, but the nurse thought it was ok for her to take the second vaccine, but the patient was not comfortable with it. No prior vaccinations within the week. The patient never taken the flu shot. She had never received the flu vaccine or pneumonia nothing, so this was new for her getting the COVID vaccine. Caller clarified the chills started the week after she received the vaccine on Wednesday 17Mar2021. Severe muscle pain: Caller stated this happened on the 19, 20, 21, and 22 as well as the throbbing pain and then the next day on Monday 22Mar2021 she went to call her doctor and had a sonogram that next day on Tuesday (23Mar2021). Caller stated she still had the muscle pain in her left leg on the inner thigh but it was more so when she was active and once in a while she felt like her leg was bruised for a day or two but then it went away and she did not have a blood clot. Left leg throbbing: Caller stated this continually got worse and then on Sunday she felt so bad she laid in bed with her knee up and it throbbed like crazy. Caller stated this stopped about 2 days after she got the sonogram and it was not that severe it was just really tender and sore. Heart palpitation: Caller clarified that the heart murmurs she referred to earlier was actually heart palpitations. Caller stated this started at 8 in the morning and then at 10 in the morning she started getting light-headed and thought about going to the emergency room and figured no she will get through this. Caller stated she called her physician for the heart palpitations on Monday and she saw her doctor the following Tuesday and that is when her doctor had given her the heart monitor. Caller stated for 6 hours she felt horrible on Saturday since she knows the difference from her normal heart palpitations from her thyroid. Diarrhea: Caller stated this last for 6 days and was last week or so. Treatment: Caller stated no she is not a medicine taker she does not even take Tylenol or Advil unless it is a necessity. Outcome of the event chills recovered on 18Mar2021, tenderness and soreness in her inner thigh of the left leg/throbbing pain was resolving, severe muscle pain and inflammation along the major vein in her leg was not resolved, heart palpitation was resolving, light headed/dizzy was resolved on 20Mar2021, diarrhea was resolved on Apr2021, leg was bruised was resolved, heart spasms was unknown. No follow-up attempts are needed. No further information is expected. follow up(20Apr2021): New information was reported from a contactable consumer (patient) included: new events (coronary spasm, pain in extremity, phlebitis lower limb and bruising of leg) and event details. Case is upgraded to serious upon this follow up. No follow-up attempts are needed. No further information is expected.
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| 65 | 2021-05-09 | joint pain, joint swelling |
My left leg and ankle became very, very swollen and sore. I experienced severe pain in my left thigh...
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My left leg and ankle became very, very swollen and sore. I experienced severe pain in my left thigh, left knee and left calf whenever I sat, walked, went up and down stairs, while sleeping and I was limited in what activities I was able to do without pain. I went to the doctor on 3/29/2021 (9 days after my first shot) and the doctor sent me for an ultrasound of the left leg and an X-ray of the left ankle..
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| 65 | 2021-05-10 | back pain |
Whole Leg Pain after second dose of Covid Vaccine; Lower back sore intermittently; This also occurre...
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Whole Leg Pain after second dose of Covid Vaccine; Lower back sore intermittently; This also occurred after both vaccines.; Leg pain making it hard to sleep; This is a spontaneous report from PPDi. A contactable nurse reported herself that a 65-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Deltoid Right on 20Apr2021 10:15 (Batch/Lot Number: ER8731) as 2ND DOSE, SINGLE for covid-19 immunization, with Age at Time of Vaccination at 65 years old. Medical history included ongoing blood cholesterol increased (Verbatim: High cholesterol. Stated she was diagnosed about 30 years ago. Said it was hereditary), ongoing autoimmune thyroiditis (Verbatim: Hashimoto's thyroiditis. Stated she was diagnosed about 20 years ago). Historical vaccine included first dose of Covid Vaccine (Batch/lot number: ER8727) on 29Mar2021 given at 1030, at Left Deltoid and experienced whole leg pain (about 2 weeks after the first vaccine she started having leg pain). Concomitant medications included rosuvastatin taken for blood cholesterol from an unspecified start date to Apr2021 (reported as Started medication about 3 years ago. Stopped a few weeks after the first dose of the vaccine, was not on any cholesterol medication at this time); levothyroxine sodium (UNITHROID) taken for autoimmune thyroiditis from an unspecified start date and ongoing. The patient experienced whole leg pain after second dose of covid vaccine (medically significant) on Apr2021 with outcome of not recovered, lower back sore intermittently (non-serious) on Apr2021 with outcome of not recovered, leg pain making it hard to sleep (non-serious) on Apr2021 with outcome of unknown. The patient underwent lab tests which included ultrasound doppler: no blood clots on Apr2021. Reported she went for her second vaccine and about 5 days later the leg pain came back. Said she took Tylenol and Motrin, nothing helps the pain. Said her legs have been hurting for about 4 days now. Stated that her pain seems unusual because it goes all the way down into her ankles and travels back and forth. Caller stated that she was a hiker and was in amazing shape. She had not done anything different, nothing that would have exacerbated this. Caller states she retired after being a Licensed Practical Nurse for 30 years in 2019. Caller stated that the leg pain after her first vaccine started about 2 weeks after the vaccine and lasted for about a week. Said it ended a few days before she got the second vaccine. Caller stated that her leg pain after the second vaccine was ongoing. Said that she got the vaccine on a Tuesday and her legs started to hurt again around Friday. Said that was effecting her life. Her legs hurt in every position. It was making it hard for her to sleep. Stated she believed her symptoms were medically significant as she did not know for sure what was causing them. Later in the call the caller mentioned that she had issues with her back. Said she noticed something new. Her lower back was sometimes sore. It comes and goes intermittently; unlike the leg pain that was constant. Stated the back pain fluctuates from a pressure and mild ache to soreness. This also occurred after both vaccines. Treatment received included: Tylenol and Motrin that did not offer any relief for her leg pains: Tylenol Extra Strength 500mg; P121876; Expiration Date: Sep 2023. Stated she took 2 tablets at a time. Motrin 200mg; 0GE2545A; Expiration Date: Mar 2022. Stated she took 2 tablets at a time. Causality: Stated she was uncertain if her symptoms have been caused by the Covid Vaccine. Follow-up attempts have been completed.; Sender's Comments: Based on the temporal association, there is a reasonable possibility that the administration of vaccination BNT162B2 played a contributory role in triggering the onset of the event pain in extremity. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.,Linked Report(s) : 2021467913 same patient/drug, different vaccine dose/AE
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| 65 | 2021-05-10 | back pain |
Whole Leg Pain after first dose of Covid Vaccine/hurt in her thighs, knees, calves, and down into he...
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Whole Leg Pain after first dose of Covid Vaccine/hurt in her thighs, knees, calves, and down into her ankles; Lower back sore intermittently/The back pain fluctuates from a pressure and mild ache to soreness; This is a spontaneous report from a contactable other nurse (patient). A 65-year-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration, administered in Deltoid Left on 29Mar2021 10:30 (Batch/Lot Number: ER8727) as First Dose; Left Deltoid for covid-19 immunization. Vaccination facility type was in pharmacy. No vaccines administered on same date of the Pfizer suspect. None prior vaccinations within 4 weeks. Family medical history relevant to AE was none. Medical history included ongoing high cholesterol diagnosed about 30 years ago (it was hereditary), ongoing Hashimoto's thyroiditis diagnosed about 20 years ago. Concomitant medications included rosuvastatin taken for blood cholesterol from about 3 years ago in 2018 to Apr2021 (a few weeks after the first dose of the vaccine); levothyroxine sodium (UNITHROID) taken for Hashimotos thyroiditis and ongoing. Patient was not on any other cholesterol medication currently. About 2 weeks after the first vaccine she started having leg pain. It was whole leg pain. It hurt in her thighs, knees, calves, and down into her ankles. She went to her doctor who did doppler studies and found no blood clots in Apr2021. Thought maybe it was the cholesterol medications that she had been on for years; so she stopped taking it. The pain in legs subsided a few days later and ended a few days before she got the second vaccine. She was a hiker and was in amazing shape. She had not done anything different, nothing that would have exacerbated this. She believed her symptoms are medically significant as she did not know for sure what was causing them. She was uncertain if her symptoms have been caused by the Covid Vaccine. The event whole leg pain after first dose of Covid Vaccine required a visit to physician office. No emergency room visited. She had issues with her back. She noticed something new. Her lower back was sometimes sore. It came and went intermittently; unlike the leg pain that was constant. The back pain fluctuates from a pressure and mild ache to soreness. This also occurred after both vaccines. The outcome of back pain was not recovered, of other event was recovered in Apr2021. The reporter (patient) was uncertain if her symptoms have been caused by the Covid Vaccine.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Pain in extremity","Back pain" and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021467940 same patient/drug, different vaccine dose/AE
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| 65 | 2021-05-10 | muscle pain |
Severe and extended dizziness for 5 days.; Headache and very tired so sleepy can hardly keep eyes op...
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Severe and extended dizziness for 5 days.; Headache and very tired so sleepy can hardly keep eyes open; Headache and very tired so sleepy can hardly keep eyes open; Headache and very tired so sleepy can hardly keep eyes open; Muscle pain around abdomen; ran fever of 102.5 for 12 hours post injection with rigors; This is a spontaneous report from a contactable nurse (patient). A 65-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200 and expiration date was not reported), via an unspecified route of administration, in left arm on 20Feb2021 at 14:30 as SINGLE DOSE for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269 and expiration date was not reported), via an unspecified route of administration, on 03Feb2021 at 17:00, as SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. Since the vaccination, has the patient not been tested for COVID-19. The patient was allergic to medications, food, or other products. The patient medical history included autoimmune disease iritis-right eye for which she was hospitalized for 2 days. Concomitant medications were not reported. On 21Feb2021, patient experienced severe and extended dizziness for 5 days. Headache and very tired so sleepy can hardly keep eyes open. Muscle pain around abdomen, generalized, ran fever of 102.5 for 12 hours post injection with rigors. The outcome of all events was reported as not recovered. No follow-up attempts are possible. No further information was provided.
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| 65 | 2021-05-11 | joint pain, muscle pain |
heaviness/burning in chest; heaviness/burning in chest; tingling/stabbing pain all over skin; red le...
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heaviness/burning in chest; heaviness/burning in chest; tingling/stabbing pain all over skin; red lesion on lower back; Shingles; light-headedness; fatigue; 101 fever; muscle aches/pain; joint pain; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID019 VACCINE; Lot Number: EK4176), via an unspecified route of administration, administered in left arm on 09Feb2021 10:00 as 2nd dose, single for COVID-19 immunisation. Medical history included osteoarthritis back/hip treated with steroid injections, bilateral knee replacements. Concomitant medications included lisinopril, hydrochlorothiazide, paracetamol (TYLENOL), and montelukast. The patient previously took levofloxacin (LEVAQUIN) and experienced known allergies. The patient also previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID019 VACCINE; Lot Number: EJ1686) administered in the left arm on 19Jan2021 at 10:30 AM for COVID-19 immunization. Vaccine facility type was hospital. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was not tested for COVID post vaccination. On 09Feb2021 at 21:00, the patient experienced heaviness/burning in chest, tingling/stabbing pain all over skin, red lesion on lower back, the worst shingles attack ever had and have had shingrix vaccine. The patient also experienced light-headedness, fatigue, 101 fever, muscle aches/pain, and joint pain. No treatment was received for all events except for shingles. The patient underwent lab test and result and included body temperature: 101 on an unspecified date. The outcome of the events were recovering.
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| 65 | 2021-05-19 | back pain |
Urinary tract infection; Her right arm got real sore, she could not lift her arm; Her right arm got ...
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Urinary tract infection; Her right arm got real sore, she could not lift her arm; Her right arm got real sore, she could not lift her arm; back hurting/lower part of back on right-hand side; soreness in legs; headache; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 04May2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored-program. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at 65 years old, dose 1, intramuscular, administered in arm right on 29Mar2021 (Batch/Lot Number: EP7533) (time given: 10:30 or 11:00) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first Pfizer COVID shot and she became sick after receiving it. She was supposed to go back on 19Apr2021 for the second dose but she was still recovering then. Patient was asking if she can she still get the second dose. Her right arm got real sore, she could not lift her arm. Then her back started hurting like it settled in lower part of back on right-hand side, she developed a real bad urinary tract infection (UTI) and soreness in legs, she could not even lay on her left side since she was in such pain. She ended up going to urgent care because she was in such pain with her back and arm. They gave her a steroid shot, antibiotic shot and oral antibiotics to take. Patient also experienced headache. She is feeling a lot better. She recovered completely around 26Apr2021. Did not require a visit to emergency room, required a visit to physician office.
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| 66 | 2021-01-04 | muscle pain |
Starting the day after vaccine I have had extreme fatigue, nausea, decreased appetite. dizziness, mu...
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Starting the day after vaccine I have had extreme fatigue, nausea, decreased appetite. dizziness, muscle aches, chills. It has continued now for 14 days, without improvement. It is actually worsening.
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| 66 | 2021-01-06 | muscle pain |
Awoke in the middle of the night with spiking fever 101.5, headache, muscle aches, diarhea, In bed f...
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Awoke in the middle of the night with spiking fever 101.5, headache, muscle aches, diarhea, In bed from Monday night to Wednesday morning started feeling better.
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| 66 | 2021-01-10 | joint pain, neck pain |
Patient had vaccine in Left arm. That same night patient had temp of 100.1 and the right neck at ba...
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Patient had vaccine in Left arm. That same night patient had temp of 100.1 and the right neck at base of head to shoulder began to hurt patient was unable to swallow without pain in the next few days. Patient went to ER and was hospitalized for 2 days treated with IV steroids and 2 antibiotics (clindamycin and acyclovir). Patients symptoms resolved and patient was discharged without additional issues. The admitting physician was unable to identify the cause of these symptoms, but the vaccine could not be ruled out.
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| 66 | 2021-01-10 | muscle pain |
1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 9...
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1/9/21-17:15- started having chills, muscle pain. Pain L arm(injection site) 18:00- low grade temp 99.3, muscle pain arms and legs worse Uncomfortable during the entire night (tossing and turning) 1/10/21- 07:30-General malaise(flu like symptoms)- muscle pain-feeling weak T-99 started feeling better during the late afternoon, still with muscle pain , T-98.7
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| 66 | 2021-01-11 | muscle pain, joint pain |
9 hours after receiving the vaccine I experienced joint pain, muscle pain, headache, fever and chill...
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9 hours after receiving the vaccine I experienced joint pain, muscle pain, headache, fever and chills. Symptoms resolved after 36 hours.
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| 66 | 2021-01-11 | muscle pain |
"45up to void min later sweat, 12hrs later when I woke up to void, I felt warm ,severe fatigue , ,...
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"45up to void min later sweat, 12hrs later when I woke up to void, I felt warm ,severe fatigue , ,muscle aches , pain some Syncope, nausea, sweating on and off, oral herpes outbreak just like I did when I had Covid -19 in April"
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| 66 | 2021-01-11 | muscle pain | Injection site pain, chills, fever, headache, muscle pain, nausea 12 hours after second vaccine |
| 66 | 2021-01-12 | joint pain | Sudden onset of severe headache, dizziness, joint pain, exhaustion at 9:00pm |
| 66 | 2021-01-13 | back pain | Body Aches Back aches chest tightness |
| 66 | 2021-01-13 | neck pain, joint pain | chills, shaking, headache, neck ache, joint pain, nausea, vomiting |
| 66 | 2021-01-14 | joint pain |
Flu-like symptoms; lethargy; athralgias; fatigue; This is a spontaneous report received from a conta...
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Flu-like symptoms; lethargy; athralgias; fatigue; This is a spontaneous report received from a contactable consumer. A 66-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in left arm, on 07Jan2021 08:00, at single dose, for COVID-19 immunization, in the hospital. Medical history included Meniere's disease and penicillin allergy. The patient was not pregnant at the time of vaccination. The patient had no other medications in two weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in left arm, on 17Dec2020, for COVID-19 immunization. The patient experienced flu-like symptoms, lethargy, athralgias and fatigue on 08Jan2021 at 21:45. The patient did not receive treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 66 | 2021-01-14 | bone pain, muscle pain |
Body chills; fever that went up to 100.4 degrees F.; fatigue; excess mucus; bone pain 10/10; muscle ...
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Body chills; fever that went up to 100.4 degrees F.; fatigue; excess mucus; bone pain 10/10; muscle pain 8/10; other vaccine same date vaccine date 05Jan2021; This is a spontaneous report from a contactable other health professional (patient). A 66-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. Medical history included DM type 2, hypertension (HTN), fibromyalgia, chronic asthma, Covid prior vaccination, No Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other vaccine same date included other vaccine same date product was Pfizer, other vaccine same date vaccine date 05Jan2021. On 06Jan2021, the patient experienced Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus. No treatment received for the adverse events Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus. The events were non-serious per the reporter. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus was recovering. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bone and muscle pain cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-01-14 | muscle pain |
Fatigue, nausea, vomiting, fever, chills, headache, muscle aches. (All began immediately following 2...
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Fatigue, nausea, vomiting, fever, chills, headache, muscle aches. (All began immediately following 2nd dose and have continued to present day. However, as of 1/15/21 symptoms have begun to subside.)
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| 66 | 2021-01-15 | joint swelling |
about 1 hour after shot i started getting bad stomach pain in the upper stomach and all over stomac...
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about 1 hour after shot i started getting bad stomach pain in the upper stomach and all over stomach and intestine cramps and 3 days later i still have them. also still have lots of nausea. body aches all over. swelling ankles more on right side, headache, fell sick all over. no treatment just staying in bed.
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| 66 | 2021-01-17 | muscle pain |
On 1/16/2021 , 4 hours after I had my Covid-19 injection my left arm started to hurt and was started...
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On 1/16/2021 , 4 hours after I had my Covid-19 injection my left arm started to hurt and was started to get real hard in the muscle. I took 2 naproxen and 2 tizandine. I could not use my left arm from 4:00 pm-10:00 pm. On 1/17/2021, I woke up and my left arm was real hard and I could not use my arm all day and night. I took 2 naproxen, 2 tizandine and 1/2 tramadol. On 1/18/2021, I woke up and my left arm is back to normal.
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| 66 | 2021-01-20 | muscle pain |
Injection site pain; chills; fever; headache; muscle pain; nausea; This is a spontaneous report from...
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Injection site pain; chills; fever; headache; muscle pain; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 66-year-old female patient received the second dose of BNT162B2 (Pfizer, lot number: EL3246), intramuscularly in left arm on 08Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included known allergies: sulfa drugs. Concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (lot number: EK5730), intramuscularly in left arm on 21Dec2020 17:00 for COVID-19 immunization. Patient experienced injection site pain, chills, fever, headache, muscle pain, and nausea 12 hours after second vaccine on 08Jan2021 22:00. No treatment was received. Patient was recovered from these events. No follow-up attempts are possible; no information is expected.
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| 66 | 2021-01-21 | joint pain |
At the time of the injection was painful, hurt from that point forward and kept on hurting all day. ...
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At the time of the injection was painful, hurt from that point forward and kept on hurting all day. Yesterday started hurting in the shoulder and arm continued, still hurts today 1/22/21. Warm to touch, still warm to touch today, knot underneath armpit.
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| 66 | 2021-01-21 | joint pain |
Hurt bad when injecting. Hurt afterwards. Still hurts 2 days later. Shoulder started hurting yesterd...
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Hurt bad when injecting. Hurt afterwards. Still hurts 2 days later. Shoulder started hurting yesterday. Today I have a big knot under armpit.
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| 66 | 2021-01-22 | muscle pain |
Nausea, headache, vertigo started 15 minutes after receiving vaccine. 24 hours later developed arm p...
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Nausea, headache, vertigo started 15 minutes after receiving vaccine. 24 hours later developed arm pain, generalized muscle aches. 36 hours after developed chills, fever 102.5, headache, fatigue 48 hours fatigue, muscle aches present but less fatigue lasted 5 days
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| 66 | 2021-01-22 | muscle pain | Tiredness, cold and muscle aches |
| 66 | 2021-01-23 | joint pain |
Severe pain from shoulder down entire arm to fingers and palm of hand. Lasted for about 32 hours. I...
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Severe pain from shoulder down entire arm to fingers and palm of hand. Lasted for about 32 hours. I felt like my rift arm was paralyzed. I had to sleep with heating pad for relief. Tylenol for pain.
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| 66 | 2021-01-26 | joint pain |
joint pains; headaches; This is a spontaneous report from a contactable other health professional. A...
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joint pains; headaches; This is a spontaneous report from a contactable other health professional. A 66-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3246), intramuscularly on 11Jan2021 at 10:00 at a single dose for COVID-19 immunization. Medical history included pre-diabetic from an unknown date and unknown if ongoing, high cholesterol from an unknown date and unknown if ongoing; known allergies: no. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; first dose-lot number: EJ1685, intramuscularly, in the left arm at 19:30) for COVID-19 immunization on 22Dec2020. Concomitant medications included calcium (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN), simvastatin (ZOCOR); all taken for an unspecified indication from an unspecified date to an unspecified date. On 12Jan2021 at 03:00, the patient experienced: joint pains and headaches; no treatment was reached. The clinical outcome of the events was recovered in Jan2021. There were no other vaccines within four weeks of the suspected vaccine. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.
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| 66 | 2021-01-26 | muscle pain | diarrhea, can't eat, 99 fever, dizzy, abdominal pain, muscle pain,fatigue |
| 66 | 2021-01-27 | joint pain |
Joint pain; Has a little bit of pain in her finger on the left hand; This is a spontaneous report re...
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Joint pain; Has a little bit of pain in her finger on the left hand; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the right arm, on 04Jan2021 15:45, at single dose, for COVID-19 immunization, in her workplace. Medical history included ongoing arthritis (has been cold there) and Crohn's disease so the patient has a tendency to have inflammation. Concomitant medication included vedolizumab (ENTYVIO). The patient experienced joint pain and had a little bit of pain in her finger on the left hand on an unspecified date in Jan2021. Treatment included Salonpas and Tylenol. The outcome of joint pain was recovering (reported as ongoing but a little better); and "has a little bit of pain in her finger on the left hand" was unknown. Information on the batch/lot number has been requested.
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| 66 | 2021-01-27 | joint pain |
Joint pain for approx. 12 hours, chills for 12 hours - extreme chills for 4 hours, accelerated pulse...
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Joint pain for approx. 12 hours, chills for 12 hours - extreme chills for 4 hours, accelerated pulse for several hours - up to 118 bpm - normal is 60-70
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| 66 | 2021-01-28 | joint pain, muscle pain |
Dizziness, muscle pain, tiredness, joint pain I woke up to use the bathroom. after relieving myself...
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Dizziness, muscle pain, tiredness, joint pain I woke up to use the bathroom. after relieving myself I stood up and got very dizzy, then I fell down. I fell again after I got myself up.
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| 66 | 2021-01-28 | joint pain | CHILLS FEVERISH BODY ACHES JOINT PAIN HEADACHE |
| 66 | 2021-01-28 | joint pain | Fever, aches, headache, swollen glands, and joint pain. |
| 66 | 2021-01-28 | back pain, joint pain |
24th Jan 2021-Sunday-hurts to breathe, coughs a lot, HA, body slows when speaking she is hoarse-remi...
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24th Jan 2021-Sunday-hurts to breathe, coughs a lot, HA, body slows when speaking she is hoarse-reminded if She gets worse-GO the ER-or have someone drive her there-for instance-SOB 25th Jan 2021-Monday-legs, to mid calves-swollen 26th Jan Tuesday-still coughing a lot 27th Jan like the 24th of Jan 2021-hurts to breathe, HA, body slows, hoarse when speaking, Cough a lot. 28th Jan 2021-Thursday-her Back hurt. Her waist & shoulder blades painful 29th Jan 2021-today-she said COVID-19 reaction-that's why she called
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| 66 | 2021-01-28 | muscle pain, joint pain | Joint and muscle pain/ lethargy |
| 66 | 2021-01-29 | joint pain, muscle pain |
24 hrs after 2nd COVID19 vaccine felt very cold and could not get warm, lead to mild chills. While...
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24 hrs after 2nd COVID19 vaccine felt very cold and could not get warm, lead to mild chills. While trying to get blankets, turning up heat, preparing dinner, had abnormal muscle and joint pain upon any movement. No muscle or joint pain while sitting still.. 6 hours after symptoms took acetaminophen 500mg and diphenhydramine 25mg . 9 hrs after onset of symptoms felt fine with no symptoms and slept through the night fine. 48 hrs after vaccine feel completely normal.
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| 66 | 2021-01-29 | joint pain |
Pfizer-BioNTech COVID-19 Vaccine EUA Side Effects: Injection site pain, tiredness, headaches, join...
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Pfizer-BioNTech COVID-19 Vaccine EUA Side Effects: Injection site pain, tiredness, headaches, joint pain, feeling unwell, swollen lymph nodes, rough-feeling throat lasting just over 24 hours
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| 66 | 2021-01-30 | musculoskeletal stiffness, joint pain, limb discomfort, muscle pain, spinal pain |
Muscle pain started with heaviness and stiffness around the injection site in left arm in the evenin...
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Muscle pain started with heaviness and stiffness around the injection site in left arm in the evening of being injected. By day two muscle pain had spread to the top of the deltoid and around shoulder joint. Through the sixth day it centralized in two knots at the topmost trapezius/supraspinatus and semispinalis capitis. The worst was day seven when the pain began to extend up and down the left side of the spine. On days eight and nine, the pain left the spine and started migrating back toward the shoulder and the knots of pain diminished. By the tenth day (today) it has localized again in the deltoid/shoulder joint and injection location. Note: No fever at any time. It appears I am recovering.
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| 66 | 2021-01-31 | joint swelling |
severe upper stomach pains and stomach pains all over and cramps; all over body pain; headache; naus...
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severe upper stomach pains and stomach pains all over and cramps; all over body pain; headache; nausea; ankles swelling more the right one; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration in the right arm on 13Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included Coronary artery disease (CAD), 2nd degree AV heart block, acid reflux, gastritis, high blood presure, fibromyalgia, gammaglobulinemia, allergies to sulfa, eggs, milk, fish, shrimp, and nuts. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valsartan (DIOVAN), esomeprazole sodium (NEXIUM), acetylsalicylic acid (BABY ASPIRIN), alprazolam, atorvastatin (LIPITOR). The patient previously took codeine, morphine, clopidogrel (PLAVIX), isosorbide mononitrate (IMDUR) and experienced allergies. On 13Jan2021 15:00, approximately 1 hour after the shot, the patient experienced severe upper stomach pains and stomach pains all over and cramps. A few hours later, she got all over body pain, headache, nausea, and her ankles were swelling more the right one. These events are all still going on 3 days later. Treatment was not provided in response to the events. The patient has not undergone COVID testing post vaccination. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 66 | 2021-01-31 | limb discomfort |
itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an ...
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itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an hour after vaccination; itching to eyes, mouth, and throat an hour after vaccination; arm soreness; dry throat; arm discomfort; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 17Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included Cholesterol and Blood pressure, patient stated she took low dose medication for her blood cholesterol and blood pressure, but has had no new medications. She had a history of some allergies: a slight shrimp and scallops allergy, possible peanuts, penicillin, and a Neomycin product. She said they were not a big deal, and she had environmental allergies as well. She had an allergic reaction to the eye drop Neomycin, possibly, just the eye drop, she had a little breakout around her lips but she didn't know if it was the drug or not. The allergy to shrimp and scallops showed up in a blood test, her reaction to peanuts around her mouth but she had a negative scratch test and blood test for allergy to peanuts. The patient's concomitant medications were not reported. The patient stated she did get the flu vaccine, that was ok, she was fine, this was probably around Nov2020 or so, though she didn't know off hand when she got it, it was the regular flu vaccine and not an increased dose. The patient experienced arm discomfort on 17Jan2021, itching to eyes, mouth, and throat an hour after vaccination on 17Jan2021 12:00. The patient took the first shot yesterday (17Jan2021) and she had some discomfort to her arm, but it didn't bother her. She got the shot about 11:00 yesterday (17Jan2021) and about an hour after the shot she had some itching to her eyes, mouth, and throat that was not severe then was on and off through the day. She would like to know if this is common, she would like the information for the second dose, if she should expect more or less or same, she was concerned about the second dose. She did not have a severe reaction, she just wanted to make sure there weren't any adverse reaction for that make sure she known. She had not seen a doctor for her itching eyes, mouth, and throat. She didn't do any treatment for it, it was better today (18Jan2021), she just noticed it an hour after the injection that she felt a bit of eyes being itchy and all over, her mouth and throat were not severe, but she definitely felt it through the day. She felt it a little at night sometimes anyway like a dry throat. It was gone this morning and her arm was better, it seemed like the itching went with the arm things since following her arm soreness her itchiness started, then when her arm felt better the itchy was going away. The outcome of events was recovering. Information on the Lot/Batch number has been requested.
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| 66 | 2021-02-01 | joint pain |
extreme tiredness, Malaise with body and joint aches, asthma minor flare up, wheezing that woke me u...
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extreme tiredness, Malaise with body and joint aches, asthma minor flare up, wheezing that woke me up during the night. Sore L upper arm
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| 66 | 2021-02-01 | joint pain | Headache, Nausea, Vomiting, Chills, Fatigue, Joint pain, Fever. |
| 66 | 2021-02-01 | armpit pain |
pain under her arm; pinched nerve in my neck and blood pressure went up to 182/98; I have pinched ne...
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pain under her arm; pinched nerve in my neck and blood pressure went up to 182/98; I have pinched nerve in my neck and blood pressure went up to 182/98; arm where she got the shot hurt like it was very tender; left breat hurt/then right breast hurt; having a little bit of trouble with asthma; congested and sneezing; congested and sneezing; bumpy rash on her chest and arms; puffiness/swelling in the neck; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration on 14Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing asthma and high blood pressure unknown if ongoing; both from unknown dates. Concomitant medications included prednisone (MANUFACTURER UNKNOWN) for asthma, unspecified vitamins and an inhaler for asthma. On 14Jan2021, the patient received the vaccination. She had a reaction to the vaccine almost immediately within 15 minutes of receiving vaccine. First, she had a pinched nerve in her neck and blood pressure went up to 182/98. Then about an hour later, the arm where she got the shot hurt like it was very tender. Then, her left breast hurt, followed by her right breast hurt. A few days later on 17Jan2021, she had breast pain and also pain under her arm. In Jan2021, she was also have some trouble with her asthma, was congested and sneezing. She had bumpy rash on her chest and arms. It was like tiny little bumps but it was not painful. She also had puffiness/swelling in the neck. The clinical outcomes of the pinched nerve in her neck, blood pressure went up to 182/98, arm where she got the shot was tender, breast pain, pain under arm, trouble with her asthma, congested and sneezing, bumpy rash, and puffiness/swelling in the neck were unknown.
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| 66 | 2021-02-02 | back pain, musculoskeletal chest pain |
Message from patietn: Due to other vaccine reactions I had to wait for 30 minutes after my shot. A...
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Message from patietn: Due to other vaccine reactions I had to wait for 30 minutes after my shot. All was okay, until I got in the car to drive home. My tongue began to tingle and headaches began. I immediately took an antihistamine as a tingly tongue for me is a sign of an allergic reaction. I then had a band like pain across my upper back, and then the chills, tiredness, nausea, sore throat, sore arm which are all normal reactions from the printed information - well except for the tingly tongue and a red rash across my nose, cheeks and chin. Tingling and rash subsided about an hour after taking the antihistamine, but all of the other symptoms remained. My shot was at 1:50 PM and just before 11 PM I had instant onset of pain in my chest wall with breathing. It went across the top of both breasts in the center where my ribs meet my sternum. This has lessoned with laying down, but when I am up and about it increases although not as bad as last night. I am also experiencing bursts of itchy spots all over. As I have an EpiPen I did not go to hospital but am wondering about what to do for the 2nd shot. I think it will be best if I take an antihistamine prior to the shot and I will continue taking them for this one until my symptoms go away.
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| 66 | 2021-02-02 | muscle pain |
I started feeling very ill the evening of my second Pfizer shot. My symptoms included headache, musc...
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I started feeling very ill the evening of my second Pfizer shot. My symptoms included headache, muscle pain, chills, nausea, vomiting and fatigue. I felt very unwell for 4 days. By Feb 1st, I started to feel better.
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| 66 | 2021-02-03 | joint pain |
Body aches; Her arm was sore/ mostly in her arm; Body aches had greatly improved. It is mostly in he...
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Body aches; Her arm was sore/ mostly in her arm; Body aches had greatly improved. It is mostly in her arm and her knees are a little achy; Chills; first dose was on 05Jan2021/ second one yesterday 19Jan2021; Kind of like the flu, like she was hit by a truck; had trouble getting off of the sofa; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: May2021), via an unspecified route of administration on 19Jan2021 11:37 at a single dose on right arm for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER9231, expiry date: Apr2021), via an unspecified route of administration on 05Jan2021 at single dose in left arm for COVID-19 immunization. The patient experienced body aches, mostly in her arm and her knees are a little achy on 19Jan2021 22:00, chills on 19Jan2021, and kind of like the flu, like she was hit by a truck, had trouble getting off of the sofa, all on Jan2021. The patient just got her second Pfizer COVID Vaccine. She experienced nothing with the first dose. She had the second one yesterday 19Jan2021. Last night she had body aches and chills. The chills are completely gone and the body aches are 85%-90% better. She called out of work today, unknowing how long these would last, and her boss told her to get this reported. She does feel better. She was warned of the second dose being more ferocious. She felt great all day. Around 10 PM the body aches started. Kind of like the flu, like she was hit by a truck. She had trouble getting off of the sofa. They told her not to take Advil as it would make the vaccine not work as good. She is used to taking Advil. She confirmed she did not take the Advil. She took Tylenol instead, this morning. She had to go out and get some. The nurse told her when she got the second dose that she would have side effects and she would feel it. Her arm was sore so she circled it around. She went this morning to the pharmacy to get the Tylenol. She is unsure if because she was moving around, or because of the Tylenol that she feels so much better. Maybe like she could even go into work at Noon. She did not take Advil or Tylenol last night, which maybe that is why she was sore. The chills only lasted about half an hour last night and 15 minutes today. Body aches had greatly improved. It is mostly in her arm and her knees are a little achy. They are normally not. She is 85% better. It is going away as we speak. The outcome of the event Body aches, Pain in arm, knee pain was recovering, chills was recovered on 20Jan2021, while for the other events was unknown.
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| 66 | 2021-02-03 | joint swelling |
Approximately 6 hours after injection, I began feeling very tired. I was up walking around office w...
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Approximately 6 hours after injection, I began feeling very tired. I was up walking around office working on some computer updates and then cam back to my office. About 15 minutes later while sitting at my desk my hand and feet began tingling, then about 10 minutes later my feet became numb, from toes to ankle, both ankles began to swell and had +Edema, and blood pressure was 123/50 , pulse low and undetected on my electronic BP cuff, taken by wrist it was 42, event lasted about 30 minutes, I forces fluids, took a Benedryl, and walked in my office when numbness subsided.
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| 66 | 2021-02-03 | muscle pain | Extreme fatigue, muscle pain all over even hair follicles hurt, Entirely snuffed up nose |
| 66 | 2021-02-03 | muscle pain |
About 15 hours after receiving the vaccine, I started with muscle aches. Then I got uncontrollable c...
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About 15 hours after receiving the vaccine, I started with muscle aches. Then I got uncontrollable chills followed by a high fever. Woke up about three in the morning with a headache over my right eye that was unbearable. Took some Tylenol and woke up this morning and just have a slight headache
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| 66 | 2021-02-04 | joint pain, joint swelling |
her wrist is swollen/just above the bone on her wrist it is swollen; it is like a burning; she has r...
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her wrist is swollen/just above the bone on her wrist it is swollen; it is like a burning; she has really bad arthritis like she has had a knee replacement/her arthritis is really bad/it just flared up; She had a little pain in her leg; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (Pfizer BioNTech COVID 19 vaccine, Batch/lot number: EL0142, Expiry Date: Mar2021), via an unspecified route of administration on 12Jan2021 09:30 at single dose in Left upper arm for covid-19 immunization. Vaccination Facility Type was at a hospital, they had a vaccine clinic set up. Vaccine Administered at Facility was No. Medical history included arthritis, she has had a knee replacement, she was allergic to anti-inflammatory medicines. Family history was none. There were no concomitant medications. No other vaccines was administered on same date of the bnt162b2. Prior Vaccinations (within 4 weeks) was None. No events occurred following prior vaccinations. Patient was calling about a question with the COVID-19 vaccine. She got it on Tuesday 12Jan2021 and she wanted to know if she could get a reaction now. Yesterday (20Jan2021) she noticed, she had really bad arthritis like she has had a knee replacement and she has it her hands and yesterday she noticed her wrist was swollen and she didn't know if it could have been where she had arthritis or could it be side effect? She just didn't know if she should call her orthopedic doctor. She said the joint at the wrist, it was like the side of her hand, it was the side where your pinky was, just above the bone on her wrist it was swollen. It was swollen normally but it usually didn't hurt like this, it was like a burning but it maybe her arthritis acting up but she did not know. She said the pain and swelling began yesterday 20Jan2021. Her wrist was swollen and it was like a burning was reported as worsened. She had a little pain in her leg the other day on 17Jan2021 but just coughed it up. It was all on the left side which was the same side she got the injection on. She didn't think anything of the leg pain and it went away. The pain in her leg has resolved completely. The only other thing was her arthritis was really bad, it just seemed that it just flared up but she was wondering if it could be a side effect. The events didn't require a visit to emergency room or physician office. The outcome of "She had a little pain in her leg" was recovered in Jan2021, while outcome of other events was unknown.
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| 66 | 2021-02-04 | joint pain, muscle pain |
Developed runny nose, sneezing, muscle aches/joint pain, nausea, scratchy throat, sinus pressure, ra...
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Developed runny nose, sneezing, muscle aches/joint pain, nausea, scratchy throat, sinus pressure, rash on chest/neck, fatigue. Saw medical provider on 2/02/2021 who suspected above due to receiving 1st dose of covid-19 vaccine.
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| 66 | 2021-02-04 | muscle pain, joint pain |
Runny nose; feeling unwell; muscle & joint aches; muscle & joint aches; chills; tired; stomach cramp...
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Runny nose; feeling unwell; muscle & joint aches; muscle & joint aches; chills; tired; stomach cramps; acid reflux; vomiting; This is a spontaneous report from a contactable consumer, reporting for herself. A 66-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, via an unspecified route of administration on 20Jan2021 at 09:15 (at the age of 66 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included obese from an unspecified date, and cancer in 1998 & 2015. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included letrozole, vitamin (unspecified), Omega, 'TransResve', calcium, 'eld'. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 12:00PM, the patient experienced runny nose, feeling unwell, muscle & joint aches, chills, tired, stomach cramps, acid reflux, and vomiting. The patient did not receive treatment for the events. The clinical outcome of runny nose, feeling unwell, muscle & joint aches, chills, tired, stomach cramps, acid reflux, and vomiting was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 66 | 2021-02-04 | muscle pain |
Chills/rigors; wheezing; shortness of breath; cough; myalgias; local vaccination site swelling as we...
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Chills/rigors; wheezing; shortness of breath; cough; myalgias; local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop); This is a spontaneous report from a contactable physician (patient). A 66-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3283), via an unspecified route of administration on 20Jan2021 at a single dose on Right deltoid for COVID-19 immunization. Medical history included Chronic lymphocytic leukemia with 65% of cells lymph's, low WBC count (13500) otherwise; DM2, A1C usually close to 6.1; HTN. Unspecified concomitant medication taken. The patient previously took nickel and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9331), intramuscular on 31Dec2020 12:15 PM at a single dose on left arm for COVID-19 immunization. The patient experienced chills, rigors, wheezing, shortness of breath, local vaccination site swelling as well as tenderness and colorimetric changes (looked like a POPeye arm with yellow/green tingling hanging down in a large tear drop), cough, myalgias on 20Jan2021 23:30. Therapeutic measures were taken as a result of the events which included Benadryl, Aleve, Nebulizer treatment, change in local temperature to help stop rigors. The outcome of the events was recovering. No other vaccine in four weeks. The patient was not pregnant. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination.
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| 66 | 2021-02-04 | neck pain |
facial numbness/possible migraine (resolved); Hypertension (resolved) Body aches, drowsiness (resolv...
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facial numbness/possible migraine (resolved); Hypertension (resolved) Body aches, drowsiness (resolved), neck pain (ongoing, possible fibromyalgia flare); ocular irritation redness (ongoing, possibly unrelated)
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| 66 | 2021-02-05 | musculoskeletal stiffness | Mild to Severe migraine still have it. Chills and stiff neck. |
| 66 | 2021-02-07 | muscular weakness |
Approximately 2 hours after her first COVID-19 Vaccine dose, patient began to feel right arm numbnes...
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Approximately 2 hours after her first COVID-19 Vaccine dose, patient began to feel right arm numbness and tingling in her hand. This progressed to right leg numbness, tingling and weakness and right lower face tingling. Patient denied any facial droop, slurred speech, confusion or dizziness. Patient reports that symptoms peaked the night of the vaccine around 9 or 10pm and had gotten better but not totally resolved. She was advised to go to the ER and was admitted. MRI showed an acute infarct in the left basal ganglia. CTA showed "short segment moderately severe narrowing of the M1 segment of the right MCA." Neurologist was consulted and determined it to be coincidental that the patient had her COVID vaccine the same day.
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| 66 | 2021-02-07 | muscle pain |
contracted Covid after my 2nd dose, 3 days to be exact; contracted Covid after my 2nd dose, 3 days t...
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contracted Covid after my 2nd dose, 3 days to be exact; contracted Covid after my 2nd dose, 3 days to be exact; This is a spontaneous report from a contactable other health professional (patient). A 66-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EL3246) at single dose at right arm on 14Jan2021 for covid-19 immunisation, administered at hospital. Medical history included rheumatoid arthritis, allergies to morphine and related, PCN, sulfa, quinidine, Xeljanz. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included: upadacitinib (RINVOQ), folic acid (FOLIC ACID), ropinirole hydrochloride (REQUIP). The patient previously received the 1st dose of bnt162b2 (BNT162B2, Lot # EJ1685) at single dose at right arm on 26Dec2020 03:00 PM for covid-19 immunisation, administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced contracted Covid after her 2nd dose, muscle aches and fatigue 3 days to be exact on 17Jan2021 17:00, Covid test result positive on 22Jan2021. Since the vaccination, the patient has been tested for COVID-19 (nasal swab): positive on 22Jan2021. No treatment was received for the adverse event. The outcome of Covid test result positive was unknown, of the other events was recovering.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported lack of efficacy cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 66 | 2021-02-08 | musculoskeletal discomfort |
Report discomfort to mid-chest with radiation to mid back. Treatment: Advil. Outcome: no improvement...
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Report discomfort to mid-chest with radiation to mid back. Treatment: Advil. Outcome: no improvement, continues to work, does not interfere with ADLS. Recommend to follow-up primary care doctor.
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| 66 | 2021-02-09 | back pain |
Did the adverse event start after the first or second vaccination? both Date and time of vaccinatio...
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Did the adverse event start after the first or second vaccination? both Date and time of vaccination: (list both if they received both shots): 1-6-2021 @ approx 10:15am Pfizer LOT # EL3246 1-27-2021 @ approx 11AM Pfizer LOT # EL9262 Date and time adverse event started: 1-31-2021 at approx 8:30am, cold hands/feet, nausea, HA, pain to bilateral eye, mid lower back aches radiating to upper. today 2-5-2021 losing voice, all symptoms are reported to be intermittent Pfizer LOT # EL3246
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| 66 | 2021-02-09 | back pain |
48 hrs after vaccination developed severe abd/low back pain. Worked up for diverticulitis but all te...
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48 hrs after vaccination developed severe abd/low back pain. Worked up for diverticulitis but all tests were WNL. 8 days after vaccination she develop blisters on left lower back and abd area and was then dx with shingles and started on acyclovir.
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| 66 | 2021-02-09 | muscle fatigue, joint pain |
sever joint pain hands, arms,shoulders; extreme fatigue; nausea; muscle fatigue; chills for 6 hours;...
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sever joint pain hands, arms,shoulders; extreme fatigue; nausea; muscle fatigue; chills for 6 hours; swollen lymph nodes left side; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at the left arm on 22Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included heart disorder (heart disease), hypertension, and obesity. The patient was not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. The patient received other medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sever joint pain hands, arms, shoulders, extreme fatigue, nausea, muscle fatigue, chills (for 6 hours as reported), swollen lymph nodes left side all on 23Jan2021 02:00 with outcome of recovering. The patient did not received any treatment for the events.
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| 66 | 2021-02-10 | muscular weakness |
3rd day I could barely move my limbs. Rash all over my upper torso. Tiny red dots in my skin Extr...
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3rd day I could barely move my limbs. Rash all over my upper torso. Tiny red dots in my skin Extremely tired. Hard time opening my eyes. Moving limbs. Slept 30 hrs.
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| 66 | 2021-02-11 | joint pain |
Chills 48 hours Severe pain in all joints 48 hours Mild pain in all joints 48 hours after severe p...
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Chills 48 hours Severe pain in all joints 48 hours Mild pain in all joints 48 hours after severe pain
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| 66 | 2021-02-12 | back pain |
HORRIBLE back pain, chills, headache. The back pain was terrible the first day and has gotten incre...
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HORRIBLE back pain, chills, headache. The back pain was terrible the first day and has gotten increasingly better throughout the week. I am finally feeling pretty good today which is five days after the second shot.
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| 66 | 2021-02-14 | joint pain |
I started with chills at 7 pm went to bed at 9pm at 3:30 I had to go to bathroom and almost fell off...
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I started with chills at 7 pm went to bed at 9pm at 3:30 I had to go to bathroom and almost fell off toilet. Caught myself but laid on floor and slept 30 min until I could get up and go back to bed. Chills were gone at this time. This morning at 10:30 I went to bathroom and blacked out. I was laying on floor but don?t remember what happened except I must have twisted my ankle and knee as they are very sore. I could not get up , no strength and hollered for Alexa to call my husband in the other part of the house. I rested in bed and finally came to couch and then around 3 ate a little but not hungry. I feel better, took a bath and resting but have a terrible headache.
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| 66 | 2021-02-14 | joint pain |
PATIENT DEVELOPED ITCHING, REDDNESS,SWELLING AND JOINT PAIN OF LEFT LOWER EXTREMITY THE DAY AFTER RE...
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PATIENT DEVELOPED ITCHING, REDDNESS,SWELLING AND JOINT PAIN OF LEFT LOWER EXTREMITY THE DAY AFTER RECEIVING COVID 19 VACCINE. SHE WAS SEEN BY HER PCP ON 2/8/21 AND VENOUS DOPPLER WAS ORDERED.
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| 66 | 2021-02-14 | muscle pain |
No reaction to first dose. However, 12 hours after receiving the second dose, I experienced the foll...
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No reaction to first dose. However, 12 hours after receiving the second dose, I experienced the following reactions, which lasted about 12 hours. Projectile vomiting and dry heaves Nausea Muscle aches, cramps, and spasms Chills Fever Sweats Headache in upper shoulders, neck, and back of head (intense)
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| 66 | 2021-02-15 | armpit pain |
Two days after the injection I began to have deep pain in my left side axilliary lymph nodes. It fel...
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Two days after the injection I began to have deep pain in my left side axilliary lymph nodes. It felt like a stabbing pain in the front part of my underarm. Over a week the pain has continued at the same level and gradually continued to spread through my underarm area. Today (with 10 days of reaction) I continue to have pain. Sometimes if feels like stinging.
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| 66 | 2021-02-15 | armpit pain |
After receiving the 2nd dose of the COVID vaccine on Sunday morning, Feb. 14, my left underarm bega...
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After receiving the 2nd dose of the COVID vaccine on Sunday morning, Feb. 14, my left underarm began to hurt in the evening. I was tired that day but no other symptoms. Through the night I had chills and sweats. In the morning there was a large lump in my left underarm. Swollen lymph glands about 3 inches wide and 2 inches deep. This has continued through Monday and now Tuesday morning it is the same. No sign of it growing larger or smaller.
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| 66 | 2021-02-15 | muscular weakness, limb discomfort, joint swelling |
1 hour after vaccine left arm and hand swelled up. 2 hours after systematic swelling in body. Pants ...
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1 hour after vaccine left arm and hand swelled up. 2 hours after systematic swelling in body. Pants were tight, right hand also swelled and feet sweliing and discomfort. 4 hours after vaccine knee joints swelled and legs wanted to give out upon standing from sitting position. Also, moderate headache. Blood Pressure was normal.
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| 66 | 2021-02-16 | joint pain |
Pain in arm that ultimately went from injection site down to wrist. Unable to raise arm for 5 days ...
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Pain in arm that ultimately went from injection site down to wrist. Unable to raise arm for 5 days Upper arm still sore after 12 days. Pain on movement and unable to sleep on that side, as the arm pain awakens me. Also, the injection seemed to be placed extremely high on the arm, about an inch from top of shoulder and in the center/front or arm where it more bone/less muscle
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| 66 | 2021-02-17 | joint pain |
On a pain scale of 1 to 10, inner aspect of right leg 7 or 8. So weird! Limping. Awakened throughout...
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On a pain scale of 1 to 10, inner aspect of right leg 7 or 8. So weird! Limping. Awakened throughout night with every movement in sleep. This lasted about 48 hours. Pressing inside aspect of right knee shot pain up to 10, radiating down to ankle and up inner thigh. Also had injection site redness, tenderness, and a raised lump, not unexpected. Had some brain fogginess two days post injection as well. No treatment; just time. Note: I'm sure I had Covid-19 in February 2020. No test available then.
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| 66 | 2021-02-18 | grip strength decreased |
The morning after receiving the vaccine in my left arm, I woke up with more than moderate pain in my...
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The morning after receiving the vaccine in my left arm, I woke up with more than moderate pain in my left hand when I tried to grip something, make a fist, or spread my fingers. I had no other symptoms besides a mildly sore arm - expected. Almost a week later, my arm is 100% (it was after a day or 2), but I still have pain in my hand. Had no pain at the time of the injection - barely felt it, so I don't think the needle hit a nerve. Could the vaccine substance have irritated the nerve? The pain seems to be focused on the center of my hand. If I press firmly on that spot, I can produce discomfort. My hand does not ache or hurt if it's at rest. The discomfort does not prevent me from carrying out the normal activities of life. Just thought I should report it. That said, happy for any thoughts about how to make it go away! Many thanks. Very grateful to be vaccinated.
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| 66 | 2021-02-18 | muscle fatigue |
Dizziness and Hot flash surges within the 15 minute time immediately after and occasionally thereaft...
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Dizziness and Hot flash surges within the 15 minute time immediately after and occasionally thereafter for about an hour. Heavy fatigue all afternoon into the evening Extreme muscle fatigue 2 and 3 days afterwards in my legs making it feel like a statin reaction hard to walk with a normal stride.
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| 66 | 2021-02-18 | muscle pain | Flushing, dizziness, nausea, headache, weird taste in the mouth. muscle ache. |
| 66 | 2021-02-18 | neck pain, joint pain |
Beginning about 3 days following 2nd Covid-19 vaccination, experienced onset of nerve pain left side...
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Beginning about 3 days following 2nd Covid-19 vaccination, experienced onset of nerve pain left side of neck, back left shoulder, radiating down left arm. Constant pain - much worse during sleep. Unable to sleep, changing positions little help - better sitting up or in high recline in bed. Treating with Tylenol, Ibupropfen periodically. Applying cold compress and warm compresses alternatively. Tried analgesic cream rub with little success. Able to exercise with little change. Rubbing of neck muscles helps somewhat.
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| 66 | 2021-02-19 | joint pain, muscle pain | Sore arm, nausea, muscle and joint pain, chills ,headache and tiredness. |
| 66 | 2021-02-19 | muscle tightness | Redness to neck and face, tightening of chest and neck, difficulty breathing |
| 66 | 2021-02-19 | muscle pain, joint pain, limb discomfort |
Pfizer-BioNTech COVID-19 Vaccine EUA Uncontrollable chills started about 12 hrs after getting vacci...
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Pfizer-BioNTech COVID-19 Vaccine EUA Uncontrollable chills started about 12 hrs after getting vaccine, lasted about 3 hrs. General chills, tiredness, headache, muscle pain, fever, some joint pain, nausea for the next 24 hrs. Fever of 99.8-100 during all this time. Heavyness and ache in lower left arm and hand
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| 66 | 2021-02-19 | muscle pain, joint pain | Joint pain, chills, headache, muscle aches, nausea |
| 66 | 2021-02-19 | muscle pain |
Nausea, vomiting, chills, diarrhea, myalgias. Insomnia during the 3 hours that nausea , vomiting and...
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Nausea, vomiting, chills, diarrhea, myalgias. Insomnia during the 3 hours that nausea , vomiting and diarrhea were occurring. Those symptoms now resolved but myalgias persist.
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| 66 | 2021-02-19 | muscle pain | Right side muscle pain, fatigue, numbness, chills |
| 66 | 2021-02-20 | joint pain |
injection site became red, warm, raised, slightly itchy, slightly uncomfortable about 8 days after t...
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injection site became red, warm, raised, slightly itchy, slightly uncomfortable about 8 days after the shot. In addition, I felt unusually fatigued on the 9th day, with noticeable arthritis pain in my thumbs (which I hadn't had for a year even though I've been playing the drums every day) - seemingly for no reason, and although I tried to do my usual exercise routine, I felt low energy and like my body just didn't feel well. I slept okay and today the arm is the same but I feel better. My thumb joints are much better, but not 100%
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| 66 | 2021-02-21 | joint pain |
Pt states severe pain in right inner elbow and outer breast. Pain and tingling started in left arm ...
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Pt states severe pain in right inner elbow and outer breast. Pain and tingling started in left arm and hand as well.
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| 66 | 2021-02-22 | joint pain |
About 8 hrs after shot my mind started feeling foggy and heavy head, i got nauseous and achy joints ...
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About 8 hrs after shot my mind started feeling foggy and heavy head, i got nauseous and achy joints and having breathing problems. i was just sic. or like i had the flu or covid again. went on through the night. was up all night. my arm was just killing me. The next morning i was full on sick. the nausea was intense my temp throughout day was 99.6 and 99.9 . out of breath. That night i went to bed and woke up at midnight and was drenched my hair was soaked Got up at showered. at the 3:30 woke up again totally drenched. yesterday i woke up and 6:00 am i was feeling better but still trouble breathing but everything else was gone. I was tired still. About 10:30 yesterday Everything was fine. I do still have a little trouble breathing but not as bad.
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| 66 | 2021-02-22 | joint pain |
Headache, felt like I was starting a bad cold , chills, low grade fever and every joint ached for 36...
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Headache, felt like I was starting a bad cold , chills, low grade fever and every joint ached for 36 hours. Then it just went away.
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| 66 | 2021-02-22 | joint pain | Very achy joints for 1 day, took tylenol |
| 66 | 2021-02-22 | muscular weakness |
This was the second dose in the vaccine series. The patient reported doing well for the first dose. ...
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This was the second dose in the vaccine series. The patient reported doing well for the first dose. A few minutes after receiving her second dose, the patient started to complain of lightheadedness, lethargy, arm weakness. She reported she did have an anaphylactic reaction to the H1N1 vaccine . Patient reported about 10 minutes after she received the vaccine she was starting to feel better- less lightheaded and was gaining arm strength. She was moved to a chair and she could not support her weight. EMS was called to the scene and she was transported to the ER.
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| 66 | 2021-02-22 | muscle pain |
Injection site pain, tiredness, headache, muscle pain up and down Rt side of body from neck to feet...
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Injection site pain, tiredness, headache, muscle pain up and down Rt side of body from neck to feet, itchy rash all over torso, heart palpitations and pain.
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| 66 | 2021-02-23 | limb discomfort, musculoskeletal discomfort, joint swelling, musculoskeletal stiffness |
The second dose caused the reaction, the first being exactly 3 wks earlier. No major problem to tha...
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The second dose caused the reaction, the first being exactly 3 wks earlier. No major problem to that dose. (Had arm pain and mild chills and fatigue). The day after dose two above noted fullness and discomfort in feet, On the second day after, had early erythematous (non-puritic) rash, mild multi-joint discomfort, 100 deg fever, and shaking chills. Doctor on call said to use judgment on starting Prednisone, since hope that this would stabilize. However, progressed and at 9am on the third day after vaccine started prednisone 40mg. At the worst, had to be dressed by husband due to pain and stiffness in upper extremities, widespread erythematous rash, fullness of skin, joint swelling.
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| 66 | 2021-02-23 | limb discomfort |
She started itching on 2/18/21 and bumps started on her legs, itching. It then spread to her knees, ...
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She started itching on 2/18/21 and bumps started on her legs, itching. It then spread to her knees, legs, side, arm and her back. It came and then it went away, then it came back again twice that day. Each day it would come and go and would leave hives on her body. She took Benadryl and then started having ankle issues, and then a ball formed on the bottom of both feet, which lasted for several hours and went away. She went to the hospital yesterday 2/23/21 and broke out into hives again and then went to the hospital as her PCP did not have an opening. They told her that they had had some report of people breaking out with hives, and told her to not to get hot, keep the house on a cool temperature. He prescribed Prednisone and Pepcid and to continue with the Benadryl and suggested to not to take the 2nd shot. She called the help desk to see if it was okay to take the Prednisone and answered her questions and told her there was no indication that she could not take it. The symptoms still come and go with the hives and itching.
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| 66 | 2021-02-23 | muscle pain |
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injec...
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Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: PATIENT PRESENTED FOR SECOND SHOT, STATING SHE STILL HAS MUSCLE PAIN FROM 1ST SHOT 21 DAYS AGO. IN ADDITION THERE WAS STILL BRUISING, AND SOME UNIDENTIFIED RED SPOTS. I INSTRUCTED HER TO CONSULT HER DOCTORE, WHICH SHE HAD NOT YET, AS THIS COULD BE A SIGN OF SOMETHING THAT REQUIRES MEDICAL TREATMENT
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| 66 | 2021-02-24 | muscle pain |
muscle soreness/mild pain at injection site (deltoid muscle) fo 24-36 hours after injection. Resolve...
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muscle soreness/mild pain at injection site (deltoid muscle) fo 24-36 hours after injection. Resolved spontaneously without requiring analgesics. No other adverse events noted.
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| 66 | 2021-02-24 | muscle pain |
Sore arm, chills, headache, muscle ache - Two doses of 500mg Tylenol 12 hours apart relieved the sym...
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Sore arm, chills, headache, muscle ache - Two doses of 500mg Tylenol 12 hours apart relieved the symptoms. Fatigue (not able to complete the routine daily walk of 3 miles) the day after vaccination for one day.
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| 66 | 2021-02-25 | back pain | pressure in temple of head, left eye issues, upper back pain left side,heavy body weight |
| 66 | 2021-02-27 | muscle pain | Chills, progressed to fever of 100 F, muscle aches, swelling and discomfort in left armpit |
| 66 | 2021-02-28 | joint pain |
Started with extreme exhaustion 1 hour after vaccination, very loose stools X3 days, extreme joint p...
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Started with extreme exhaustion 1 hour after vaccination, very loose stools X3 days, extreme joint pain 1 1/2weeks- pain continues until present, headache for 12hours with headache off & on continues, cough x 5 days
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| 66 | 2021-02-28 | armpit pain |
Patient began to have shooting pain under her left arm that comes and goes. Vital signs were taken ...
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Patient began to have shooting pain under her left arm that comes and goes. Vital signs were taken and all with in normal limits. Patient was observed not intervention or medication given after full 15 min wait time Patient was feeling better and went home.
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| 66 | 2021-02-28 | armpit pain |
tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come...
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tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come and go; felt like she had Covid again; She got hot; chills; really sick last night; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9261), via an unspecified route of administration in the left arm on 27Jan2021 at 11:10 (at the age of 66-years-old) as a single dose for covid-19 immunisation . Medical history included diabetes mellitus from 1995 and ongoing , ongoing hypertension , covid-19 from an unknown date and unknown if ongoing (Had Covid at Christmas). The facility in which the vaccine was received was a Workplace Clinic There were no concomitant medications. No other vaccines were given within 4 weeks. On 27Jan2021 The patient reported she was sick last night, tenderness under her arm pits, headache, nausea, diarrhea and she felt like she had a fever that would come and go. She got hot and then had chills. She felt like she had Covid again. Treatment included Zofran and it helped with the nausea. There was No physician office visit and No emergency room visit as a result of the events The clinical outcome of the events Nausea, diarrhea, was recovered on 27Jan2021, tenderness under both armpits recovered on 28Jan2021, Headache non recovered, Fever was recovering, while felt like she had Covid again, Feeling hot Chills and Sick unknown.
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| 66 | 2021-02-28 | muscle pain, joint pain | Flushing at 1130, fatigue during first day, extreme joint and muscle pain second day |
| 66 | 2021-02-28 | muscle pain |
veins in her hands are still swollen in the arms, its like the veins popped up; Numbness in arms and...
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veins in her hands are still swollen in the arms, its like the veins popped up; Numbness in arms and Hands; Tingling in Arm and Hands; some pain in the injection arm; muscles pain in the hands; a freezing cold sensation in her hands/her hands were frozen for 3-4 seconds; I would wake up with one hand completely numb; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in left arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included osteopenia and osteoporosis. She was shrinking, her height was about 5 feet 5 inches, she used to be 5 feet 7 inches. Concomitant medication included calcium carbonate, colecalciferol (CALCIUM WITH VITAMIN D3 [CALCIUM CARBONATE;COLECALCIFEROL]), fish oil, vitamin e nos (OMEGA 3 [FISH OIL;VITAMIN E NOS]), vitamin b12 [vitamin b12 nos] (VITAMIN B12 [VITAMIN B12 NOS]), and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). It was reported that on 09Jan2021, she received the first dose of the vaccine. She started to feel tingling and numbness in both hands the same day after the vaccine was administered. She states she also had some pain in the injection arm and that the numbness/tingling was off and on and traveled to her arms occasionally. She states, "I would wake up with one hand completely numb and it was worse the first 15 days but is getting better and is a little less than before." She states she would have a freezing cold sensation in her hands occasionally and she states her veins were more prominent and visible in her hands/arms around the 13th day after getting the vaccine. She further reported that when she received the vaccine, that same afternoon she started feeling a tingling sensation in the hands and arms, also a sensation of numbness like electrical accompanied with muscle pain. The Numbness and Tingling was on and off and well as the muscles pain in the hands. It was more noticeable 13-14 days later now. She would be sleeping at night and would wake up because of the sensation in the left hand or on the other right hand. The hands would wake her up. She provides an example of its like when your foot is asleep with the pins and needles, because you had your foot squished under for a while, like the foot falling asleep but in this case she wasn't doing anything and would have that feeling. Once or Twice when having breakfast she noticed that her hands were frozen for 3-4 seconds. After the 13 or 14 days, things are milder but now she still has the sensation, its not so often but milder. She also notices the veins in her hands are still swollen in the arms, its like the veins popped up. She is still having this. She is concerned since she is suppose to get second injection on 30Jan2021, she is concerned if she should still it. She is nervous. She clarifies that the first dose was on 09Jan2021 at 10 or 10:15 AM. On the same day is when she started noticing the Numbness and tingling in the Hands and arms on 09Jan2021. She noticed the Veins popping on 22Jan2021. Caller clarifies that she has no side effects in the legs, she was just providing that comment as an example. The outcome numbness in arms and hands, tingling in arm and hands, wake up with one hand completely numb, was recovering; pain in the injection arm, muscles pain in the hands, freezing cold sensation in her hands was unknown; and veins in her hands are still swollen in the arms was not recovered. The reporter assessed the events as non-serious.
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| 66 | 2021-02-28 | neck pain |
Headache in the back of my neck radiating up into the back of my head; Headache in the back of my ne...
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Headache in the back of my neck radiating up into the back of my head; Headache in the back of my neck radiating up into the back of my head; Projectile vomiting; Dry heaves; Fever; Chills; Muscle spasms; Swollen glands; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported) on 26Jan2021 (10:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included allergy-induced asthma; Celiac disease; bradycardia; was a pacemaker user (for bradycardia); sulpha allergy; and latex allergy. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), alprazolam, lisinopril, montelukast, and other unspecified medications. The patient previously took cephalexine, and had allergy. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported) on the left arm on 07Jan2021 (when the patient was 66 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 26Jan2021 (23:00), the patient had headache in the back of the neck, radiating up into the back of the head; projectile vomiting; dry heaves; fever; chills; muscle spasms; and swollen glands. The patient did not receive any treatment for the reported events. The outcome of the events, 'headache in the back of the neck, radiating up into the back of the head', 'projectile vomiting', 'dry heaves', 'fever', 'chills', 'muscle spasms' and 'swollen glands', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
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| 66 | 2021-03-01 | muscular weakness |
Within 3-5 Minutes, I got severe shooting pains in my left temple that went across my forehead with ...
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Within 3-5 Minutes, I got severe shooting pains in my left temple that went across my forehead with headache, Felt extremely hot and Red rash appeared on my face on both cheeks and when I got up to leave I had weakness in my legs and was dizzy. Was given benedryl by the pharmacist who stated it look liked I had a reaction. Still had pain in left temple, headache, rash and dizzyness the next day along with scratchy throat. Headache and pain in temple mild after 3 days. I am concerned about second dose only because of shooting pains in my left temple.
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| 66 | 2021-03-01 | muscular weakness |
Patient received 2nd Covid 19 Pfizer vaccine shot on 22 February 2021. The patient had a past histo...
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Patient received 2nd Covid 19 Pfizer vaccine shot on 22 February 2021. The patient had a past history of having a reaction to the H1N1 vaccine. patient reports she did well with her first COVID vaccine-reports no issues. A few minutes after the vaccine was injected, it was reported from the nurse the patient was lethargic, sluggish, and the patient complained of arm weakness and lightheadedness. Fire department arrived to the scene first and vital signs were taken, all vitals were WNL. Patient's glucose was 119 on her continuous BG monitor. She reported she was feeling better, but still weak. Her vitals in the ED were BP 174/81 and HR of 53. The patient stated she felt better and decided she did not need treatment in the ED.
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| 66 | 2021-03-02 | joint pain, back pain |
terrible gas and bloating - starting 12 hours after injection and lasting 1 day, rapid and irregula...
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terrible gas and bloating - starting 12 hours after injection and lasting 1 day, rapid and irregular heart rhythm - beginning 40 hours after injection - lasting 6 hours, extreme tiredness - day 7 & 8, lower back and hip pain - day 7 and currently day 10, general feeling unwell - most days
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| 66 | 2021-03-02 | joint pain |
pt states that about a week after getting the covid vax that she has developed severe pain from the ...
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pt states that about a week after getting the covid vax that she has developed severe pain from the upper part of her right hip down to her knee. Pt had an appt w/ Dr. on 2/25/2021 regarding her symptoms. She was prescribed tramadol HCL 50mg and methylprednisolone 4mg. Pt states she is going to have to contact her doctor since this medicine is not working and she is still in severe pain. She has been off from work for a week but had to go back and states it is very difficult since she cant hardly get up and down.
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| 66 | 2021-03-02 | armpit pain |
burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left...
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burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; charlie horse like cramps in left arm, hand and shoulder.; left breast swelled up; left armpit swelled up; This is a spontaneous report from a contactable consumer (patient). A 66 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263), via an unspecified route of administration (on left arm) on 27Jan2021 10:00 (at the age of 66 -years-old), single dose for COVID-19 immunization. Medical history included back surgery, knee surgery both on 2018. The patient's concomitant medications were not reported. Caller received 27Jan2021: 15 min after injection burning down her left arm, left breast and axillary swollen painful, charlie horse like cramps in left arm, hand and shoulder. She is drinking water, taking Tylenol, and using a heating pad but symptoms are persisting. Consumer states she is getting some interesting side effects from the vaccine. Adds she received the vaccine on 27Jan2021 10:00AM. Reports within the first 15 minutes she noticed just some burning down her left arm but then her left armpit swelled up; her left breast swelled up and she started to experience charlie horses in her arm. Adds now the pain has come down a little. She has been drinking water, taking Tylenol, and using a heating pad and that has helped a little. The pain comes and goes. It is worse at night when she lies down. Now it is in her hand, charlie horsing in her hand. She thinks maybe the shot got into her lymph nodes. Mentions the swelling her left armpit and breast has gone down some but the pain is still there. Clarifies patient received the first dose of the Pfizer COVID 19 vaccine on 27Jan2021 at 10:00AM on the left arm. She is scheduled for the second dose 24Feb2021. The outcome of the event Swelling arm, Breast swelling, Axillary pain, Axillary lymph nodes enlarged was recovering, other events was not recovered.
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| 66 | 2021-03-03 | muscle pain |
I had a headache within an hour of the injection. The next day, my left arm hurt (which was to be e...
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I had a headache within an hour of the injection. The next day, my left arm hurt (which was to be expected), muscle aches and pain, headache still, fatigue, shortness of breath and chills. By 8:30 pm I had a temperature of 101.7. I took some Tylenol and took my temperature again at 10:00 pm. It was 100.8. The next morning (3/3/21), I took my temperature again at 6:00 am. It was 101.1. I still had a headache, body aches and fatigue. I took more Tylenol and my temperature was down to 100.8 within an hour. Had a temperature most of the day ranging from 99.5 to 100.0. My normal temperature is usually 97.9. Still very tired. On Thursday March 4th, feeling better. Still a little tired. Temperature is 98.3.
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| 66 | 2021-03-03 | weight decreased |
DIZZINESS, DISORIENTATION, UNSTEADY GAIT, SEVERE HEADACHE, NAUSEA WITHIN 10 MINUTES OF VACCINE; THES...
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DIZZINESS, DISORIENTATION, UNSTEADY GAIT, SEVERE HEADACHE, NAUSEA WITHIN 10 MINUTES OF VACCINE; THESE SIDE EFFECTS CONTINUED ALONG WITH EXTREME FATIGUE, NO APPETITE, LOSS OF 6 LBS IN 6 DAYS, WEAKNESS. SYMPTOMS STILL PERSISTING ON DAY 8.
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| 66 | 2021-03-04 | armpit pain |
The day after my vaccination I had soreness in the armpit of my left arm. It was pretty uncomfortabl...
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The day after my vaccination I had soreness in the armpit of my left arm. It was pretty uncomfortable the first three days, but continues the pain is subsiding.
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| 66 | 2021-03-04 | musculoskeletal stiffness | Chills, headache, stiff neck, lethergy |
| 66 | 2021-03-04 | neck pain, musculoskeletal stiffness |
I got very dizzy at the time of injection and the room was spinning, I sat for 30 minutes and they w...
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I got very dizzy at the time of injection and the room was spinning, I sat for 30 minutes and they watched me and let me go after. I immediately begin to feel very tired and couldn't think, my neck began to hurt and feel stiff and started having chills and still having chills.
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| 66 | 2021-03-05 | joint pain, arthritis |
Low grade fever, headache, body ache, where I have arthritis pain was intensified and unbearable, s...
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Low grade fever, headache, body ache, where I have arthritis pain was intensified and unbearable, somewhat lightheaded, vision slightly blurred-felt like I was in a tunnel, very tired and couldn?t sleep . I had control of my arthritis and as of today (3/6/21) 16 days after shot it is mostly painful, 7 out of 10. Mild lingering headache, and have trouble sleeping.
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| 66 | 2021-03-06 | joint pain, musculoskeletal stiffness, arthritis |
About 2 hours after the 2nd dose vaccine, I began to have upper leg aches. By 4 hours I was hurting...
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About 2 hours after the 2nd dose vaccine, I began to have upper leg aches. By 4 hours I was hurting very badly in both legs and had a very stiff neck and a headache. I have arthritis all over my body. I am not sure if the vaccine brought on the pain or if my arthritis caused the pain. But, I have not had that much pain with my arthritis before the 2nd dose vaccine. I was in so much pain I could not find a comfortable position in my bed to be able to go to sleep. I was awake until dawn. Finally, the pain became less and I was able to fall asleep and sleep about three hours. Today, 3-8-21, I feel fatigued and still have minor pain in my ankles. Like I said I have never been in so much pain before. The 1st dose vaccine only gave me a very sore arm.
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| 66 | 2021-03-08 | bone pain, back pain | Fever , My bones hurt legs and arms low part of my back My head hurt so bad sick to my stomach |
| 66 | 2021-03-08 | groin pain, muscle pain |
Slight arm soreness, tired next day, abdominal muscle sore, groin pain, slight headache, none of the...
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Slight arm soreness, tired next day, abdominal muscle sore, groin pain, slight headache, none of these were bad, just noticeable, and seem to have resolved in 2 days.
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| 66 | 2021-03-08 | muscle pain |
12 hours after 2nd shot, for the next 48 hours, fever continuously @ 99.9, severe muscle pain from h...
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12 hours after 2nd shot, for the next 48 hours, fever continuously @ 99.9, severe muscle pain from head to toe, that was not effected by motrin. fever and severe muscle pain had me rolling in bed with pain. Also simultaneously, My left arm, site of injection swelled twice its size, red, and had trouble moving it. Also noticed a swelling in left arm pit, which has improved but a slight swelling is still present . after exactly 48 hours , fever left, muscle pain stopped. Fatigue continued for 5 days. I have had many vaccines in my life, including flu vaccine every year and never experienced such severe symptoms. When I reported this to my PCP, he said it just means your immune system is doing its job no worries
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| 66 | 2021-03-08 | muscle pain | Chills, fever, muscle and body aches, headache, naseua |
| 66 | 2021-03-09 | joint pain, muscle pain |
injection site pain, redness, and swelling; injection site pain, redness, and swelling; injection si...
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injection site pain, redness, and swelling; injection site pain, redness, and swelling; injection site pain, redness, and swelling; headache; chills; muscle and joint pain; muscle and joint pain; nausea; dizziness; weakness; This is a spontaneous report from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM9809), via an unspecified route of administration in the left arm on 06Feb2021 13:30 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included slightly elevated blood pressure, not taking medication, and COVID prior to vaccination, on an unspecified date. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included paracetamol (TYLENOL) and vitamin supplements. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Feb2021 16:00, the patient experienced injection site pain, redness, and swelling; headache, chills, muscle and joint pain, nausea, dizziness and weakness. No treatment was received for the events. The clinical outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 66 | 2021-03-09 | joint pain |
My bicep where I was injected was swollen and hard and hurt very badly. I could not elevate my arm, ...
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My bicep where I was injected was swollen and hard and hurt very badly. I could not elevate my arm, I had to keep it my side. I also had a headache. 9 days after the injection I had extreme fatigue and wasn't myself. During the night My right arm/shoulder started throbbing and hurting again. I was cold and lightheaded. When I woke up I was fine!
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| 66 | 2021-03-09 | muscle pain, joint pain |
Muscle aches, fuzzy headed, headache, chills and lots of pain in my knee replacement done 9/21/2020...
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Muscle aches, fuzzy headed, headache, chills and lots of pain in my knee replacement done 9/21/2020. That knee pain abated after a few hours.
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| 66 | 2021-03-10 | joint pain | Woke up. Low grade fever. Slight headache. Joint pain and trouble walking. |
| 66 | 2021-03-10 | arthritis |
site of shot got red, warm, painful, and raised in 3" x 3" area 9 days after vaccine. This took 3-4...
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site of shot got red, warm, painful, and raised in 3" x 3" area 9 days after vaccine. This took 3-4 days to go away. Also, I experienced severe fatigue and feelings of arthritis in my hands which both lasted about 24-30 hours.
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| 66 | 2021-03-10 | muscular weakness |
About 10 minutes after receiving the vaccine, my left arm started burning. This lasted maybe 15 min...
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About 10 minutes after receiving the vaccine, my left arm started burning. This lasted maybe 15 minutes. I did not have this with the first vaccine. Around 7pm I started to develop chills which over a few hours I started to have shaking from the chills. I also developed a headache, Temperature 101.1, muscle weakness, pain at insertion site and diarrhea. I used Tylenol and Advil. Around 0500 no longer experienced a temperature and chills had lessened. Continued on day two to have slight chills and headache along with weakness. Day 3 minimal weakness
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| 66 | 2021-03-11 | muscle pain |
Pain left arm and all over body, muscle aches, felt feverish but didn't take temp, headache, lost ap...
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Pain left arm and all over body, muscle aches, felt feverish but didn't take temp, headache, lost appetite.
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| 66 | 2021-03-12 | armpit pain |
My lymph above my breast on left side became sore and it became difficult to take a deep breath. A c...
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My lymph above my breast on left side became sore and it became difficult to take a deep breath. A couple of days later, the pain continued over to my right side also and same difficulty getting a deep breath. For awhile, the pain was in my right armpit too. Put warm compresses on areas and it helped a bit. My sister looked up info on the internet and found that ?Aleve? might help the pain, which it did. Called the doctor?s office and they were not very helpful. The information my sister got from the internet was of more help. The difficulty getting a deep breath lasted 2 weeks.
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| 66 | 2021-03-13 | limb discomfort |
Received second COVID vaccine at 11:30 am on 3/12. Woke up around 3am on 3/13. Heaviness in limbs,...
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Received second COVID vaccine at 11:30 am on 3/12. Woke up around 3am on 3/13. Heaviness in limbs, chills. Took Tylenol. Woke up around 7am. Not feeling any better. The tip of my tongue felt as if it was dipped in hot sauce. Slept most of the day. Chills came back. Took Tylenol. Today (3/14), better, but still weak. Under my tongue is very sore.
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| 66 | 2021-03-14 | back pain |
Shortness of breath, chest pain, chills, fatigue, pain in back, nausea - Went to ER Feb 28, 2am - sy...
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Shortness of breath, chest pain, chills, fatigue, pain in back, nausea - Went to ER Feb 28, 2am - symptoms continue for another week.
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| 66 | 2021-03-14 | bone pain | Severe bone and head pain also cold like symptoms for 5 days |
| 66 | 2021-03-14 | muscle pain |
Swollen painful lymph node in armpit and another between armpit and elbow; Swollen painful lymph nod...
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Swollen painful lymph node in armpit and another between armpit and elbow; Swollen painful lymph node in armpit and another between armpit and elbow; Fever of 100 degrees; Deep muscle pain in small areas that lasted few seconds, moved from one part on body to another; Headaches; Congestion; This is a spontaneous report from a contactable consumer (patient). This 66-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9269) via an unspecified route of administration on 05Feb2021 at 13:30 (at the age of 66-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hypothyroidism and pre-hypertensive. The patient had COVID-19 prior to the vaccine on an unknown date. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included HCTZ and levothyroxine sodium (LEVOTHYROXIN) from unknown dates for unspecified indications. The patient previously took penicillin from an unknown date for an unknown indication and experienced allergy. On 05Feb2021 at 14:30 the patient experienced swollen painful lymph node in armpit and another between armpit and elbow, fever of 100 degrees, deep muscle pain in small areas that last few seconds, moved from one part on body to another, headaches, and congestion. The events were reported as non-serious. The patient was not hospitalized for the events and did not receive any treatment for the events. The outcomes of swollen painful lymph node in armpit and another between armpit and elbow, fever of 100 degrees, deep muscle pain in small areas that last few seconds, moved from one part on body to another, headaches, and congestion were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 66 | 2021-03-14 | neck pain |
I rec'd my first Covid vaccine shot on 3/3/21 in my right arm. I had soreness in the arm for 2 days...
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I rec'd my first Covid vaccine shot on 3/3/21 in my right arm. I had soreness in the arm for 2 days afterwards. On Wednesday, March 10, 2021, I got severe pain behind my left ear and down the left side of my neck. Saturday morning, March 13,2021 my lips were numb and I was not blinking my left eye and I could not close my left eye. I went to the doctor Monday morning, March 15,2021 and she confirmed Bell's Palsy. Blood was drawn and I was given prescription medication.
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| 66 | 2021-03-15 | joint pain |
3/12/2021 Presented to the ED with left wrist pain and cat bite. Admitted for IV antibiotics for lef...
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3/12/2021 Presented to the ED with left wrist pain and cat bite. Admitted for IV antibiotics for left wrist cellulitis.
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| 66 | 2021-03-15 | joint pain |
I had no reaction after the 1st dose administered on January 26, 2021 other than a slightly sore arm...
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I had no reaction after the 1st dose administered on January 26, 2021 other than a slightly sore arm. After the second dose on Febrary 16, 2021, I expereinced the following in the following order. I did not feel better/normal until March 12. 101 fever for 24 hours, headache for days, chills, slight nausea, pain and aches all over and in joint areas, pain under shot arm in gland areas, black eyes and eye aches, divertiulitus event, brain fog - not being able to have sharp recall, and hives last 7 days.
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| 66 | 2021-03-15 | neck pain, back pain, joint pain, muscle tightness |
Morning after 1st shot awoke with sore back and neck. Appeared swollen like inflammatory response to...
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Morning after 1st shot awoke with sore back and neck. Appeared swollen like inflammatory response to shot as day of shot felt fine. I did go to Physical Therapy that morning for knee but didn't do anything out of the ordinary since had been doing that for weeks. That night was in so much pain couldn't get into bed. Pain radiated from back to hip to thigh, and down shin, with no feeling in shin. Muscles very tight and was very odd. Seen by provider the next day and received Toradol shot. That did not provide relief so went to local ER. X-rays revealed pinched nerve. Now maybe that was because of the inflammatory response or pure dumb luck. Still in lot pain and will receive cortisone shot next week 10 days after 2nd dose today. Providers feel not related, but one provider said if my back was inflamed even a simple reaching for glass in cupboard could pinch nerve. I was not going to report but then saw someone posted on (social media) had muscle pain and spasms which sounded like what I had. I believe my inflammatory response to shot drove me to the pinched nerve situation. Been in pain for weeks and had to go to 2nd shot in wheelchair.
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| 66 | 2021-03-16 | muscle tightness |
Patient was being observed for 30 minutes, did not complain of any symptoms during this time. When o...
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Patient was being observed for 30 minutes, did not complain of any symptoms during this time. When observation nurse was checking on patient to allow the to leave, resident complained of light headed. Patient brought to triage for evaluation. Patient reported they had a Vasovagal response 6 years ago. Vital signs were taken, all within normal limits. Ice pack was applied to back of neck, as patient felt flushed and juice was given. Patient said she did not eat breakfast when asked. Patient was observed being very restless and rubbing/scratching her arms, scalp and upper back. Rash was noted on upper back left side, NO hives. Benedryl 50 mg IM was given. Called patients friend, patient did not want emergency contact called for pickup. Patient's friend was willing to come and pick her up. Patient observed with diminished restlessness and itching. Patient reported a "tightness" in her neck muscles, almost like she had swollen glands. Patient was able to talk well, no c/o of SOB or difficulty breathing or itchiness of her throat. Patients friends arrived, informed of the incident. Patient was sleepy, rash was gone, patient denied any more itching, patient appeared more peaceful. Advised if she had any worsening symptoms or signs of a severe allergic reaction to call 911. Patient stayed in total for 90 minutes. Patient was assisted by nurse to her friends car.
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| 66 | 2021-03-16 | musculoskeletal stiffness |
Approx 5 hours follow Pfizer vac,, developed localized stiffness in the muscle. No redness or swel...
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Approx 5 hours follow Pfizer vac,, developed localized stiffness in the muscle. No redness or swelling. The following morning her arm was very sore from shoulder to elbow. On the 3rd day her arm hurt from shoulder to elbow when she raised it, and has not resolved at this time. The discomfort improves with use, but is sore/stiff again after a period of nonuse of that arm.
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| 66 | 2021-03-17 | muscular weakness |
About 5 minutes after the vaccine, pt develop left arm weakness and left facial numbness. States sh...
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About 5 minutes after the vaccine, pt develop left arm weakness and left facial numbness. States she has no pain in her arm. Denies chest pain, dizziness, swelling, itching, rash or sob.
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| 66 | 2021-03-18 | joint pain | Joint pain, Onset on 3/1721 - mild. Increases on 3/18 and 19th. |
| 66 | 2021-03-18 | musculoskeletal stiffness, back pain, joint pain |
Pfizer-BioNTech COVID-19 Vaccine EUA? Got home, got out of car - lower back pain. (like very stiff ...
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Pfizer-BioNTech COVID-19 Vaccine EUA? Got home, got out of car - lower back pain. (like very stiff sore muscles across entire lower back) Lasted 28 hours, Went away, That night left hip pain began. And back became stiff again, but not as severe. Tried to avoid taking any meds for it, but had to take Ibuprofen on 3;19;21 AM for pain. Since I was unable to bend over. Pain seems to be better now. But still have aching in upper left thigh. And some in lower back.
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| 66 | 2021-03-18 | neck pain, back pain |
Extreme pain at injection site, then left arm became paralyzed, unable to move unless assisted by ri...
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Extreme pain at injection site, then left arm became paralyzed, unable to move unless assisted by right hand/arm. Pain spread to left side of head, neck, upper, then lower back. Extreme pain in lower back. General feeling of un-wellness, and wanting to die. Insomnia, and extreme tiredness. Thursday pm pain in left arm subsided, still very tired, severe pain in low back, slept better. Friday, as I write, no more pain in left arm, paralysis subsided, as well as head, neck pain. Low back pain still exists. Did not seek medical help. Took Hydrocodone and Tylenol, iced areas of pain. Not looking forward to next shot. Will contact my allergy doctor regarding if I should get second shot.
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| 66 | 2021-03-20 | back pain | Upper back and left side, breast pain. |
| 66 | 2021-03-20 | muscle tightness |
tiredness, headache, chills, severe pain in lower left abdominal region, muscle tightness in right c...
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tiredness, headache, chills, severe pain in lower left abdominal region, muscle tightness in right calf, repeated vomiting, constipation
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| 66 | 2021-03-20 | muscle pain |
Headache-muscle aches all over- fever of 102 Took Tylenol overnight was unable to sleep because pain...
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Headache-muscle aches all over- fever of 102 Took Tylenol overnight was unable to sleep because pain from symptoms. Still going and the time is 9;30AM Sunday March 21st
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| 66 | 2021-03-20 | muscle pain | Fever exceeding 102 degrees, extreme muscle pain, chills |
| 66 | 2021-03-20 | neck pain |
Symptoms/reactions started one week after I received the vaccine. I stated having severe pains in m...
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Symptoms/reactions started one week after I received the vaccine. I stated having severe pains in my left arm from the elbow up to my shoulder and left side of neck, with the site of the shot/vaccine being very tender and extremely painful. I can't hold my hand down, it is very sensitive, I can't turn my head around or even tilt my head back to gargle my throat.. I have to hold my hand in a certain way because it hurts terribly.
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| 66 | 2021-03-21 | joint pain |
Day of injection, no adverse affects. That evening after I went to bed, I was woken up by extreme pa...
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Day of injection, no adverse affects. That evening after I went to bed, I was woken up by extreme pain and soreness at the injection site. I had a terrible time sleeping. It radiated into my shoulder and lasted for four days. I didn't sleep well at all the entire time and I was affected by the pain during the day as well. I also had extreme fatigue the next day after the vaccination but that only lasted for that day.
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| 66 | 2021-03-21 | muscular weakness |
Extreme confusion, symptoms similar to stroke, legs weak, could not stand or walk. Difficulty form...
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Extreme confusion, symptoms similar to stroke, legs weak, could not stand or walk. Difficulty forming words. Words were very garbelled. Extremes sweatness. chills.
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| 66 | 2021-03-21 | muscle pain, joint pain | SEVERE PAIN IN THE ARM, SEVERE HEADACHE, MUSCLE, JOIN PAIN AND HIGH HEVER FOR 3 DAYS (38.8 - 39.3 C) |
| 66 | 2021-03-21 | muscle pain | Severe migraine and extreme muscle pain from elbow to hands (both arms) |
| 66 | 2021-03-22 | arthritis, musculoskeletal stiffness, joint pain |
chills x 24 hours, body aches and fatigue x 3 days. Improved x 24 hrs. Then developed stiff neck, ...
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chills x 24 hours, body aches and fatigue x 3 days. Improved x 24 hrs. Then developed stiff neck, joint pain and inflammation in joints with arthritis
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| 66 | 2021-03-22 | muscle pain, armpit pain, neck pain |
Low grade fever, widespread muscle pain (#8 on pain chart) severe headache, mild nausea, fatigue, sw...
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Low grade fever, widespread muscle pain (#8 on pain chart) severe headache, mild nausea, fatigue, swollen , painfull glands in neck, soreness at site of injection that traveled into armpit,
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| 66 | 2021-03-22 | neck pain |
Got flu like systems the following day and each day felt weaker with headache and ear and neck pain ...
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Got flu like systems the following day and each day felt weaker with headache and ear and neck pain thought flu ignored. Then felt worse went to urgent care tested negative for corona virus. Seen by dr on site.12/12/21. Double ear infection. Home with antibiotics, got worse. Face extreme pain went to ER at hospital due to left side face dropping and speech slurring was diagnosed with double ear infection and Bell Palsy on 3/14/2021.
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| 66 | 2021-03-23 | joint pain, back pain, neck pain, groin pain |
Approximately 12 hours after shot (during the night), I woke up with debilitating pain in multiple p...
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Approximately 12 hours after shot (during the night), I woke up with debilitating pain in multiple parts of my body: wrists; left groin and leg; neck/shoulders; lower back and had a headache. All of these areas were thrubbing and interrupted sleep. Also was very weak. Was difficult to get out of bed or a chair and to walk. Also had loss of appetite. At no time, did I have a temperature.(Note: I play tennis so was very active early in the week). The course of the symptoms has lasted 96hours but now seems to be subsiding. After 48 hours of inability to do any normal life activities, I contacted my physician who prescribed a cordtisone shot and anti-inflamatory medication, which I've taken for 2 days.
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| 66 | 2021-03-23 | joint pain, muscle pain |
Started overnight (after 9:30pm on 3/23/21: Injection site pain,Tiredness,- The following occurred a...
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Started overnight (after 9:30pm on 3/23/21: Injection site pain,Tiredness,- The following occurred around 8am on 3/24/21: Headache,Muscle pain, Chills, Joint pain, Fever, Nausea, Feeling unwell, Dizziness, Fainting
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| 66 | 2021-03-23 | neck pain |
Two weeks after the vaccination I woke up dizzy. Couldn?t walk without balancing assistance, headach...
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Two weeks after the vaccination I woke up dizzy. Couldn?t walk without balancing assistance, headache and nausea. Took Tylenol. Rested 2 hours, still some dizziness, headache, nausea. Improved by 2:30 pm after more rest. I had arm and neck pain , nausea and fatigue for 4 days after the vaccination.
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| 66 | 2021-03-24 | joint pain |
Neuropathy type sensation in feet, lower legs, hands; difficulty breathing; tongue felt tingly and s...
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Neuropathy type sensation in feet, lower legs, hands; difficulty breathing; tongue felt tingly and swollen; raised red itchy rash on neck, chest and abdomen; swollen lymph glands in throat; diarrhea; sore throat; site soreness; achy joints; headache; nausea; fatigue; Racing heartbeat; throat felt lujeir was closing; tongue felt tingly and swollen; This is a spontaneous report from a contactable healthcare professional (the patient). A 66-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6205), via an unknown route of administration in the left arm on 06Mar2021 at 16:30 (at the age of 66-years-old) as a single dose for Covid-19 immunization. Medical history was included celiac sprue, Crohns, chronic pancreatitis, psoriasis, osteoporosis, and ulcerative colitis, all from an unknown date and unknown if ongoing. The patient was allergic to penicillin and codeine. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9269) on 13Feb2021 at 11:30 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported however it was reported the patient had other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 16:30, within 5 minutes of injection, the patient experienced Racing heartbeat, difficulty breathing, tongue felt tingly and swollen, throat felt lujeir was closing, and neuropathy type sensation in feet, lower legs, hands. The patient also experienced the typical side effects of site soreness, achy joints, headache, fatigue, nausea, sore throat, diarrhea, swollen lymph glands in throat, and raised red itchy rash on neck, chest and abdomen. Treatment of Benadryl was given for the events as recommended by paramedic which was still being taken on day 4. The clinical outcome of the events racing heartbeat, difficulty breathing, tongue felt tingly and swollen, throat felt lujeir was closing, and neuropathy type sensation in feet, lower legs, hands was recovered on 06Mar2021 (reported as 'last about 10 minutes'); outcome of site soreness, achy joints, headache, fatigue, nausea, sore throat, diarrhea, swollen lymph glands in throat and raised red itchy rash on neck, chest and abdomen was not recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-03-25 | joint pain |
Same day as vaccine administered 3/15/2021 Headache. Tiredness. During the early morning hours on 3...
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Same day as vaccine administered 3/15/2021 Headache. Tiredness. During the early morning hours on 3/16 Big Toe throbbing woke me up. Throbbing stopped in big toe and then moved to right wrist, then stopped at wrist and went to left leg. Throughout the next 24 hours their would be sharp pains in right ankle. Left arm at injection sight very painful. Pains would occur in different body parts next 24 hours. Extreme tiredness to the point of ongoing sleep well passed the 6 hours of regular sleep for me. It took 4 days for me to start to feel I was returning to normal function, the fifth day I felt normal. I thought this was a long time to recover from shot in comparison to what I did hear.
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| 66 | 2021-03-25 | muscle pain, joint pain |
I started fever 100.8 the next morning after the second vaccine, then climbed up to 101.2 in the af...
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I started fever 100.8 the next morning after the second vaccine, then climbed up to 101.2 in the afternoon. I also had attacking pain here and there, in joint, or muscles. It moves around every few seconds. I drank a lot of water and slept a lot. All symptom were gone by the evening. And I felt my normal self. But I started feeling a lump in the neck yesterday, feels like swollen lymph node. When i touch it or swallow food I feel the pain. Not sure if it is vaccine related. I feel it is. So I decided to report. Since it is Friday night now I couldn't check with my doctor till at least Monday.
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| 66 | 2021-03-25 | muscle pain |
Received Vaccine on 3/16/21 and on 3/18/21 developed nausea and muscle pain in back, hip, and legs. ...
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Received Vaccine on 3/16/21 and on 3/18/21 developed nausea and muscle pain in back, hip, and legs. Has been taking Aleeve and Tylenol with no relief. Has appointment with PCP this afternoon. Reported PCP gave Steroids, muscle relaxer and antinausea medicine.
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| 66 | 2021-03-25 | neck pain, muscle pain |
has been feverish, weak, temperature of 99.8 on 3/25 10:33 PM PDT, neck, and throat hurts, sore musc...
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has been feverish, weak, temperature of 99.8 on 3/25 10:33 PM PDT, neck, and throat hurts, sore muscles, very sore at the injection site, diarrhea, nausea, headache, tender scalp These symptoms are unchanged after 24 hours (started approx 10 pm 3/24 is is now after 10pm 3/25.
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| 66 | 2021-03-26 | musculoskeletal stiffness |
high fever, headaches very ill. Neck stiff and the gland were swollen. could not eat or drink and se...
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high fever, headaches very ill. Neck stiff and the gland were swollen. could not eat or drink and severe pain and weakness.
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| 66 | 2021-03-26 | neck pain, back pain |
Day after had chills, fever 101.4 neck ache, back ache both legs ache stuffy nose and cough. Took co...
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Day after had chills, fever 101.4 neck ache, back ache both legs ache stuffy nose and cough. Took covid test at pharmacy on March 24, 2021 and Test came back positive for Covid-19 on March 26,2021. Still have a low grade fever 99.2, stuffy nose, lost sense of taste and smell, ache in neck ,back, and legs head ache on and off.
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| 66 | 2021-03-27 | musculoskeletal discomfort |
Received vaccine, within 10 minutes developed a red rash on neck with small hive. Given benadryl, im...
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Received vaccine, within 10 minutes developed a red rash on neck with small hive. Given benadryl, improved within 30 minutes.
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| 66 | 2021-03-28 | joint pain, joint swelling |
Swelling and pain in hands, feet and knees began approximately two weeks after second vaccine and is...
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Swelling and pain in hands, feet and knees began approximately two weeks after second vaccine and is still continuing. Have been to ER, twice to PCP, second appointment with Rheumatologist on 4/1/21. No abnormal results to 23 lab tests/bloodwork, ECG/EKG, X-rays.
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| 66 | 2021-03-28 | joint pain |
Rash to vaccinated left arm- mild- below vaccination site to elbow, and SOB Vitals: B/P: 156/82, HR...
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Rash to vaccinated left arm- mild- below vaccination site to elbow, and SOB Vitals: B/P: 156/82, HR: 60, Resp: 12 02Sat: 99, Skin signs: Cool, dry. Denies itching c/o cold fingers, Circulation: Cap refill <2 sec, Resp.: Breathing sounds clear bilaterally. Treatment: observed for 30 mins and assess breathing 30 mins. Reassessment: 13:00 Vitals: B/P: 138/88, HR:60 Resp.: 12, O2Sat: 98, Treatment; Rash is lighter but still present denies SOB c/o left shoulder aching. Moved from triage to observation area to be observed by Dr. for 30 mins. Walked to restroom a steady. denies dizziness and SOB. Gave patient bottled water. Discharged home by self
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| 66 | 2021-03-28 | joint pain |
feels drugged; fluid in her chest that she didn't have before; Coughing and spitting up white mucous...
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feels drugged; fluid in her chest that she didn't have before; Coughing and spitting up white mucous out of her chest; feels so tired; no appetite, food doesn't taste right; sweating and chills; sweating and chills; feels weak; extremely sick; joints and arms hurt; joints and arms hurt; doesn't feel like walking around/Lethargic; can't hardly even talk to people; Headache; feels like she has been poisoned; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9267), via an unspecified route of administration on Left arm on 09Mar2021 between 15:00 and 16:00 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient states she took that shot on Tuesday and she is still sick and still doesn't feel good. States that she feels better, but she is coughing and spitting up white mucous started on 10Mar2021. She feels like she has been poisoned in Mar2021. States that she is coughing stuff up out of her chest. States that she took this on Tuesday (09Mar2021) and still feels drugged and tired. She states that it made her extremely sick and she is not taking the second shot. She states she took the shot Tuesday and didn't get sick until three to four hours after, she was down feeling so bad, like an ailment or disease. She states she feels like we gave her the Covid. She states she won't even go to the hospital because can't trust anyone. States that her joints and arms hurt and can't hardly even talk to people on 09Mar2021. States she has fluid in her chest that she didn't have before on 10Mar2021. States that this is the first day she has gotten out of bed. States that she is not taking the second shot. States that she had to sit for fifteen minutes after her shot and she felt fine. Clarified that she couldn't eat, she had sweating and chills for two to three days and she couldn't even get out of bed on 19Mar2021. States she feels better but still feels weak and lethargic on 09Mar2021. States it has improved since yesterday. States that her food doesn't taste right but no appetite on 09Mar2021. States the sweating and chills ended 11Mar2021. She states that she had a headache and it started on 09Mar2021 and it went away 12Mar2021 with treatment of Aspirin. Not sure if she is going to recover. Prior to vaccination, was the patient was not diagnosed with COVID-19. The outcome of events Poisoning; feels drugged, extremely sick was unknown, for Coughing and spitting up white mucous out of her chest was not resolved, for headache it was resolved on 12Mar2021, for feels so tired; no appetite, food doesn't taste right; joints and arms hurt; doesn't feel like walking around; can't hardly even talk to people; feels weak; Lethargic was resolving, for fluid in her chest that she didn't have before was not resolved, for sweating and chills it was resolved on 11Mar2021. Follow-up attempts are completed. No further information is expected.
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| 66 | 2021-03-28 | back pain, joint pain |
No issue with the first shot of 3/3/2021, the second shot of 3/24/2021 was a different story. Headac...
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No issue with the first shot of 3/3/2021, the second shot of 3/24/2021 was a different story. Headache, even my hair hurt. Joint pain, backache, eyes sensitive to light, nauseated spent most o the night throwing up. Dizzy & weak. Arm hurt & swollen as well. It is now 5 days later and I'm still not 100%. I missed 2 days of work and rested as much as possible over the weekend.
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| 66 | 2021-03-28 | back pain |
Extreme nerve -like pain up and down left arm, elbow, wrist, hand, fingers, shoulder, upper left bac...
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Extreme nerve -like pain up and down left arm, elbow, wrist, hand, fingers, shoulder, upper left back. Pain started a few minutes after injection. Pain continues. It has been 4 days.
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| 66 | 2021-03-28 | musculoskeletal stiffness, joint pain, muscle pain |
peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination;...
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peripheral neuropathy in face; Covid-like symptoms; allergic reaction immediately after vaccination; dizziness; weakness; tingling; increased heart rate; brain fog; fatigue; chills; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; muscle and joint soreness and stiffness; swollen lymph nodes; intermittent heart racing for 3 more days; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration, administered in the left arm on 10Mar2021 at a single dose (at the age of 66-years-old) for COVID-19 immunisation. Medical history included mild asthma, arthritis, known allergies: react to some food, insect bites, and had a bad reaction to shingles vaccine. There were no concomitant medications. The patient had no other medication in the last two weeks and no other vaccine in the last four weeks. On 10Mar2021, the patient experienced an allergic reaction immediately after vaccination which included dizziness, weakness, tingling, increased heart rate - lasting approximately 2 hours; followed by COVID-like symptoms of brain fog, fatigue, chills, muscle and joint soreness and stiffness, peripheral neuropathy in face, swollen lymph nodes and intermittent heart racing for three more days. The patient was not COVID tested post vaccination. No treatment was given in response to the events. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-03-28 | muscle pain, neck pain |
About 12 hours after I receive my second vaccine I woke up with a severe migraine and neck pain. I h...
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About 12 hours after I receive my second vaccine I woke up with a severe migraine and neck pain. I had slight muscle aches and injection site pain but they were not bothersome. The migraine however lasted two days.
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| 66 | 2021-03-29 | joint pain |
Within 90 minutes, headache and fatigue. 4 months later, profound fatigue with daily unrelieved head...
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Within 90 minutes, headache and fatigue. 4 months later, profound fatigue with daily unrelieved headaches, and joint pain and swelling
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| 66 | 2021-03-30 | joint swelling |
I am having liver and kidney issue which could be reason for my ankles are swelling; I am having liv...
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I am having liver and kidney issue which could be reason for my ankles are swelling; I am having liver and kidney issue which could be reason for my ankles are swelling; Muscle cramps in right calf; My feet are swelling and it has been swelling for about 4 days now; Swelling in my ankles; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number EP8982; Expiration Date: 31JMay2021) via unspecified route of administration on 21Jan2021 as single dose for COVID-19 immunisation. Medical history included lung neoplasm malignant, asthma, neoplasm malignant. Concomitant medication included ALECENSA taken for lung neoplasm malignant, SPIRIVA, fluticasone propionate, ADVAIR, DUPIXENT and XARELTO taken for neoplasm malignant. The patient experienced swelling in my ankles (joint swelling) on 26Jan2021, muscle cramps in right calf (muscle spasmson 24Mar2021, my feet are swelling and it has been swelling for about 4 days now (peripheral swelling) on 26Jan2021, i am having liver and kidney issue which could be reason for my ankles are swelling (liver disorder , i am having liver and kidney issue which could be reason for my ankles are swelling (renal disorder). The patient underwent on Jan2021 lab tests and procedures which included blood test: unknown results, On Jan2021 computerised tomogram: unknown results. The outcome of the events are unknown. Follow up is completed. No further information is expected.
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| 66 | 2021-03-30 | muscle pain, joint pain |
feeling very tired; headache; Muscle pain; Joint pain; Nausea; feeling unwell like the flu; feeling ...
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feeling very tired; headache; Muscle pain; Joint pain; Nausea; feeling unwell like the flu; feeling unwell like the flu/awful; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261) intramuscularly on 21Jan2021 at single dose in left arm for COVID-19 Immunization. Medical history and Concomitant medications were not reported. It was reported that she wanted to report reaction to Pfizer Covid 19 vaccine. stated she was very tired, headache, muscle pain, joint pain, nausea, feeling unwell like the flu. Was injected on 21Jan2021 and this started on 22Jan2021. stated that it has been awful since then. Is her first shot. Stated that since she had such a bad time with the first one should she get the second one. stated that the outcome of feeling very tired and muscle pain varies and cannot be directly determined. Stated that feeling very tired and muscle pain is ongoing. Treatment was reported as none. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-03-30 | muscle pain |
Extreme fatigue and muscle and body aches; slightly elevated body temp, loss of appetite, slept 15-1...
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Extreme fatigue and muscle and body aches; slightly elevated body temp, loss of appetite, slept 15-18 hours
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| 66 | 2021-03-30 | muscle pain |
body aches; stomach pains; tiredness; feeling unwell; nausea; Body tingling; dizziness; This is a sp...
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body aches; stomach pains; tiredness; feeling unwell; nausea; Body tingling; dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot Number: EL8982, Expiry date: Unknown) via an unspecified route of administration in left arm on 10Feb2021 09:00 as single dose for covid-19 immunisation. Medical history included chronic depression, high cholesterol and first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Formulation: Solution for injection, Lot Number: EL3248, Expiry date: Unknown) via an unspecified route of administration in left arm on 21Jan2021 17:15 as single dose for covid-19 immunisation. There was no special history of allergies. Concomitant medications included citalopram 20 mg, aripiprazole 2 mg and rosuvastatin for an unspecified indication. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 09:00, the patient experienced body tingling and dizziness. 3 days after injection on 14Feb2021, the patient experienced body aches, stomach, tiredness, feeling unwell and nausea. The patient hasn't been tested PCR for COVID-19 since the vaccination. Therapeutic measures were not taken as a result of adverse events. The outcome of the events were reported as recovering.
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| 66 | 2021-03-30 | muscle pain |
Headache, muscular aches, low-grade fever, chills, diarrhea, fatigue, light-headedness. Treated with...
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Headache, muscular aches, low-grade fever, chills, diarrhea, fatigue, light-headedness. Treated with bedrest.
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| 66 | 2021-03-30 | neck pain, facial discomfort, muscular weakness |
Chest pain; Pressure in head & face; Pressure in head & face; Pains in nape, across the shoulders an...
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Chest pain; Pressure in head & face; Pressure in head & face; Pains in nape, across the shoulders and front/top head; Weakness in arms right worse than left; Tingling in right hand; Nausea; Salty taste in mouth; Elevated blood pressure; Dry mouth; Indigestion; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration in left arm at the age of 66-years (non-pregnant at the time of vaccination), on 01Feb2021 at 08:00 AM at a single dose for COVID-19 immunization. The patient's medical history included osteopenia and allergies to PCN (penicillin) and latex. Concomitant medication included glucosamine, curcuma longa (TURMERIC [CURCUMA LONGA]), fish oil (OMEGA 3 [FISH OIL]), calcium citrate (CITRACAL [CALCIUM CITRATE]), colecalciferol (VIT D3), cranberry, and biotin. The patient previously took first dose of bnt162b2 (Lot number: EK9231), via an unspecified route of administration in left arm at the age of 66-years, on 13Jan2021 at single dose for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. The patient experienced pressure in head & face, pains in nape, across the shoulders and front/top head, weakness in arms right worse than left, tingling in right hand, nausea, salty taste in mouth, elevated blood pressure, dry mouth, and indigestion on 05Feb2021. The patient also experienced chest pain on 10Feb2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement on 05Feb2021: elevated; nasal swab on 11Feb2021: pending result. The patient received paracetamol (TYLENOL) and ibuprofen (ADVIL) as treatment for the events. The patient also used heating pad and icepack as treatment for the events. The outcome of the events was not recovered.
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| 66 | 2021-03-30 | weight decreased, muscle pain |
both injection sites arms itchy, swollen red; Spots on her arm where both injections were, she said ...
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both injection sites arms itchy, swollen red; Spots on her arm where both injections were, she said they were itchy and warm to touch, red and swollen; Spots on her arm where both injections were, she said they were itchy and warm to touch, red and swollen; When she got injection it was sore/spots on her arm where both injections; sick; I don't have a fever; I am not dizzy anymore; I am not hot or weak anymore; I am not hot or weak anymore; I am not having muscle aches any more; I still don't have an appetite; I have asthma/I noticed with a first shot I sopped wheezing/can take a deep breath without coughing, without wheezing/improved my lungs as well; I am thirsty right now I am drinking so much water; I have not been out of the house out of the bed/trouble getting out of bed; I lost a low weight/maybe 4-5 lb; chills and shakes; chills and shakes; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: Unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration on 22Feb2021 as SINGLE DOSE for covid-19 immunization. Medical history included obesity, asthma (with a first shot of vaccine the patient stopped wheezing/can take a deep breath without coughing, without wheezing, improved the lungs as well (therapeutic response unexpected), blood pressure measurement, illness from an unknown date. The patient's concomitant medications were not reported. The patient received 1st dose on 22Feb2021 and 2nd dose on 15Mar2021. The patient experienced both injection sites arms itchy, swollen red, spots on her arm were itchy and warm to touch, red and swollen in 2021 with outcome of not recovered. The patient also conveyed that she doesn't have a fever, not dizzy anymore, not hot or weak anymore, not having muscle aches anymore in 2021 with outcome of recovered. The patient also complained that she still doesn't have an appetite don't have an appetite on 2021 with outcome of not recovered. The patient also complained of thirst, lost 4-5lb weight, chills and shakes in 2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 96.4 on 22Mar2021. Information on Lot/Batch number was available. Additional information has been requested.
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| 66 | 2021-03-31 | back pain |
Headache for 3 days (3/12-3/14) & muscle aches & lower back pain 3/14-3/20 & major fatigue 3/13-3/20...
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Headache for 3 days (3/12-3/14) & muscle aches & lower back pain 3/14-3/20 & major fatigue 3/13-3/20. I took Extra strength Tylenol for the headache. I took Tylenol during the day for muscle aches & lower back; & Tizanidine muscle relaxer each night. By 3/18 I was exhausted & slept from 6:30 pm 3/18 to 9:45pm on 3/19. Was awake 1.5 hrs & was back to bed sleeping until 8:45am on 3/20/21.
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| 66 | 2021-03-31 | back pain | Mild upper back ache, nausea, headache, fatigue |
| 66 | 2021-03-31 | muscle pain |
Beginning 6 hours after her second dose of Pfizer COVID-19 vaccine she had severe headache, body ach...
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Beginning 6 hours after her second dose of Pfizer COVID-19 vaccine she had severe headache, body aches, myalgia, shaking. Symptoms did not improve after the 48-hour mark and continued until the time of this report 8 days later. She has a history of fibromyalgia which has been very well controlled and this feels to her like her fibromyalgia has been reactivated by the vaccine. She also reports some swelling below the jaw on the left and physical exam confirms submandibular gland enlargement. . She had emergency room visit on 3/29/2021.
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| 66 | 2021-03-31 | neck pain, joint pain |
My shoulder joints and back of neck felt sore about 30 mins after the vaccine. About 2 hours after t...
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My shoulder joints and back of neck felt sore about 30 mins after the vaccine. About 2 hours after the vaccine I felt exhausted. I tried to ignore it but could not concentrate on my work and ended up going to bed and falling asleep for 3 hours. Got up briefly and then slept through the night. The next day I was completely exhausted and couldn't work so I gave up and went to bed. I had mild chills but no fever (67.3). Basically stayed in bed all day. The next day I woke up feeling completely fine, except for a sore arm at the injection site. I had no treatment. I still have days when I feel exhausted. Since most get these symptoms after the 2nd shot I'm a bit concerned that my 2nd may be worse.
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| 66 | 2021-03-31 | neck pain, armpit pain |
Severe tinnitus like pounding noise, headaches, dizziness,off balance,fatigue,neck pain, pain in lef...
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Severe tinnitus like pounding noise, headaches, dizziness,off balance,fatigue,neck pain, pain in left armpit.
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| 66 | 2021-04-01 | joint pain |
Soreness in arm 4/1/21 4:30 am to 4/2/21 7:00 am Now less painful. Headache 4/1/21 4:30 am to 4/1/2...
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Soreness in arm 4/1/21 4:30 am to 4/2/21 7:00 am Now less painful. Headache 4/1/21 4:30 am to 4/1/21 9:00 pm Now gone Aches in joints 4/1/21 7:00 am to 4/2/21 7:00 am Now gone Tylenol 2 caps 4/1/21 at 12:00 pm and 7:00 pm and 4/2/21 7:00 am
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| 66 | 2021-04-01 | muscle pain |
1st 12 hours- When I got the shot, I felt that it got me a little high. Woke up with achy muscles, f...
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1st 12 hours- When I got the shot, I felt that it got me a little high. Woke up with achy muscles, fever up 4 degrees, bad headache. Weak and couldn't get up. Took Tylenol and did nothing about 12 hours in. 20 hours- Finally took aspirin and headache and fever and aches went away. 36 hours- had some pretty bad diarrhea. Low energy. 48 hours to present- Low energy
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| 66 | 2021-04-02 | joint pain |
body aches, Severe headache, sore throat, ear ache, was awaken in the night with what seemed like a ...
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body aches, Severe headache, sore throat, ear ache, was awaken in the night with what seemed like a convulsion, severe shakes, all my joints hurt so bad I couldn't walk, hard time breathing. 2 days later i still feel fatigue and have a headache
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| 66 | 2021-04-02 | muscular weakness |
received care of pt at 955. C/o of both lower extrem feeling weak. 02sat 100% 135/87 HR82 RR NML. ...
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received care of pt at 955. C/o of both lower extrem feeling weak. 02sat 100% 135/87 HR82 RR NML. 0958 18778 HR112 Sat 100% seems to be feeling improved. Now we have an interp on the phone and pt states her usual BP is in the 160s. 1002 Moved to cart, Transferred fine. Confirms feeling weak but denies any new symptoms. 1004 192/84 HR87 1007 193 HR89 1008 states feeling some CP just over heart, no diaphoresis or other symptoms. No arm or jaw pain. 1009 Interp at bedside, EMS called. 1011 199/99, HR 99 sat 100 1014 EMS here 201/93, 107, bloodsugar 135, still feeling CP and enroute with EMS>
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| 66 | 2021-04-02 | muscle pain |
Fatigue, Fever, muscle pain, dizziness, nausea over 2 24 hour periods, then fever broke with night s...
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Fatigue, Fever, muscle pain, dizziness, nausea over 2 24 hour periods, then fever broke with night sweat and was better 4th day after vaccine
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| 66 | 2021-04-03 | back pain, armpit pain |
Started with profuse eye tearing. Woke up with extreme headache, teeth aching, non stop runny nose, ...
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Started with profuse eye tearing. Woke up with extreme headache, teeth aching, non stop runny nose, it felt like aching golf balls in my left breast, armpit and upper back. (lymph nodes) Extreme fatigue, could not eat for 23 hrs. As of 5 days later I still am having pain and swelling in my armpit. Dizziness.
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| 66 | 2021-04-07 | joint pain |
Sore left arm; Tiredness; Joint pain (mild); This is a spontaneous report from a contactable consume...
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Sore left arm; Tiredness; Joint pain (mild); This is a spontaneous report from a contactable consumer (Patient herself). A 66-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200, Expiration date: Not reported) via an unspecified route of administration in the left arm on 19Feb2021 14:00 at SINGLE DOSE for COVID-19 Immunization. The patients medical history included crown disease, penicillin allergy and tetracycline allergy from an unknown date and unknown if ongoing. Concomitant medications included Vedolizumab (Entyvio), Montelukast, prilosec (omeprazole) and Albuterol inhaler (Salbutamol). The patient had not taken other vaccine in four weeks. The patient had not experienced COVID-19 prior to vaccination and not tested positive for COVID-19 after vaccination. The patient experienced Sore left arm, tiredness, joint pain (mild) on 19Feb2021 at 21:00. The patient has not received treatment. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-04-15 | limb discomfort |
Received second shot on April 2@ 1130am. Started with diarhhea and vomiting's on April 6 at 3:30 a...
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Received second shot on April 2@ 1130am. Started with diarhhea and vomiting's on April 6 at 3:30 am. Continued to 4:30 am on April 10. Slight elevated temperature at 99.1 . On morning of April 11 couldn't put pressure on right side, leg and arm, facial numbness. Went to er and they said I was having a stoke, transferred to hospital. MRI done verified Stroke with blood clot to Left thalamus Sent home and will be receiving PT and OT.
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| 66 | 2021-04-17 | back pain, joint pain |
Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurt...
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Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Unable to lift arm, pain makes her catch her breath/ Difficult to take a deep breath; Thought she was having a heart or panic attack; Stress, heart rate, panic; soreness from the shot; Stress, heart rate, panic; Stress, heart rate, panic; Stress, heart rate, panic; Tingling in hands and down the arm; crying; This is a spontaneous report received from contactable consumer (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 66-years-old on 22Mar2021 13:57 (Lot Number: EN6208) as single dose for COVID-19 immunization. Medical history included migraine. Concomitant medication included topiramate taken for migraine from 15Mar2021 and ongoing. The patient had her shot last Monday afternoon and had some soreness from the shot on Mar2021. On Tuesday, 23Mar2021, it began getting sore back behind her shoulder blade; it has gotten progressively worse, and now she can barely lift her arm. She does not know if it's a muscle or has to do with the vaccine, or if she pulled a muscle although she has not done anything. It's difficult to take a deep breath, she can't lift her arm, it is sore. It hurts down into her chest and around her breast; also, hurts around on her back where her shoulder blade is. She has tried heat compress, cold compress, and massage the area. It seems like the pain will ease up but then it starts again. She becomes stressed about it and her heart rate starts panicking. She gets tingles down the arm. Thought she was having a heart or panic attack. It has gotten worse as the week has progressed. It was worse on Sunday; even worse on Monday; worse yesterday and she was crying. She has also been stressed at work. Doesn't know whether to go to the doctor or an urgent care, or if she needs to. The patient is 66 years old and says she is in fairly good health. Right now she is unable to lift her arm and has tingles in the hand and down the arm. The pain makes her catch her breath. If this gets much worse she is going to go have it checked out. Again mentions that she has been having stress. It does seem to be a little worse. The patient experienced thought she was having a heart or panic attack on Mar2021, stress, heart rate, panic on Mar2021, soreness from the shot on Mar2021, soreness to left arm, hurts in chest around breast, back, shoulder blade on 23Mar2021, unable to lift arm, pain makes her catch her breath/ difficult to take a deep breath on Mar2021, tingling in hands and down the arm on Mar2021, and crying on Mar2021. The outcome of the event Soreness to left arm, hurts in chest around breast, back, shoulder blade was not recovered while for the rest of the events was unknown. Prior Vaccinations (within 4 weeks) was None. She had an unspecified shot but reiterated no vaccines. No AEs following prior vaccinations.
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| 66 | 2021-04-17 | back pain |
her pain is worse constantly and she can hardly use the opposite arm; even to touch the skin is extr...
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her pain is worse constantly and she can hardly use the opposite arm; even to touch the skin is extremely painful; her cubicular lymph node was swollen; the area between her neck and armpit has swelled up more and more; pain in between neck and armpit; pain goes into back; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), dose 2 parenteral (reported as "injection") at the age of 66-years-old on 19Mar2021 (Batch/Lot number was not reported) as single dose in Arm Left for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received bnt162b2 (BNT162B2), dose 1 on an unspecified date for COVID-19 immunization. The patient received the first vaccine with no problem. She received the second vaccine on Friday 19Mar2021 and the next day, 20Mar2021 it felt like her cubicular lymph node was swollen. Every day since then, the area between her neck and armpit has swelled up more and more. Her pain is worse constantly and she can hardly use the opposite arm and even to touch the skin is extremely painful. This is on the opposite side from where she received the shot. The event "area between neck and armpit swelled up" started 20Mar2021 and is ongoing. It increases constantly and it is almost disabling it is in between medically significant and disabling. It has worsened. The event "pain in between neck and armpit" started the past Friday (Mar2021) and is ongoing. It is medically significant but almost disabling as she cannot use her right arm. This has worsened. The event "pain goes into back" started 2 days ago and is ongoing. This is medically significant and has worsened. Treatment was received for the events. The doctor gave her Toradol injection intramuscular and it did not effect anything and she has also taken Tramadol and Flexeril, a muscle relaxer, which did not effect anything. Her doctor has never seen anything like the symptoms she is experiencing. She had an X-ray done but she does not have the results yet as it was done yesterday (29Mar2021). The outcome of the events "her cubicular lymph node was swollen" and "even to touch the skin is extremely painful" was unknown while for the rest of the events was not recovered. Relatedness to COVID 19 vaccine: area between neck and armpit swelled up, pain in between neck and armpit, pain goes into back - Related. Information on the batch/lot number was requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-04-17 | muscle fatigue, muscle pain |
seizures; muscle fatigue; hives; rash from head to toe; sore muscles; wrap around headache; This is ...
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seizures; muscle fatigue; hives; rash from head to toe; sore muscles; wrap around headache; This is a spontaneous report received from a contactable healthcare professional (patient herself). A 66 -year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EN6208; Expiration Date: 30Jun2021) as a single dose for COVID-19 immunisation. She provided a brief history from 2017. She was walking her dog and she fell and suffered a concussion, she had a seizure, then she developed bipolar disorder. She's been taking sodium valproate (DEPAKOTE) for her seizures since 2017. She reports she's very active. She's not an old lady. She can run circles around some 22 year old's. In September of 2017, she had a concussion and had seizures. She's been on sodium valproate (DEPAKOTE) since that time. She's not mentally ill, the concussion she got in 2017 caused her brain to turn bipolar. It's hard for people to understand that. Sodium valproate (DEPAKOTE) was 500mg. She takes 1 tablet in the morning and 2 tablets at night because it can make you sleepy. She reports she was recently hospitalized in Feb2021 for atrial fibrillation with rapid ventricular rate (RVR). Her heartrate was 181 beats per minute, her blood pressure was dropping, she tested positive for rhinovirus and the doctor thinks the atrial fibrillation with RVR was caused from the rhinovirus. She was allergic to bee venom and carries an EPI PEN. Medical history also included ongoing high blood pressure from an unspecified date (controlled with medication). Concomitant medications included ongoing metoprolol tartrate (LOPRESSOR) taken for blood pressure; ongoing lisinopril; ongoing valproate semisodium (DEPAKOTE) taken for seizure from 2017; ongoing hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) taken for blood pressure; paracetamol (TYLENOL) from an unspecified date in 2021. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EM9810; Expiration Date: 30Jun2021). The patient did not receive any recent vaccines for any other conditions or any recent vaccines for any other conditions prior to the event being reported; or any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient reported that with the second Covid 19 vaccine she had two seizures on 27Mar2021. The seizures were back to back. The seizures resolved within 2 minutes. She had fatigue from an unspecified date, sore muscles and a wrap around headache on 26Mar2021. The wrap around headache felt like she was going to have a stroke even though her blood pressure was fine. She monitored her blood pressure at her home. She feels it's weird that they publish that the second Covid 19 vaccine is going to be worse. She thought she'd have muscle soreness and fatigue but not seizures. She looked it up and the wrap around headache and seizure are the rarest things that can happen after receiving the Covid 19 vaccine. She stayed in bed from Friday afternoon after she received the second Covid 19 vaccine on 26Mar2021 and started to feel better Sunday afternoon, 28Mar2021. Her blood pressure and pulse were both fine with her wrap around headache. She had fatigue with both Covid 19 vaccines. She also developed hives, which she still has. She has a rash from her head to her toes. It looked like she rolled around in an ant bed. The hives were clearing up. She was using an anti-itch cream. The hives and the rash started midday on Saturday, 27Mar2021. She only has around 5 hives now on her chest. She hasn't taken Benadryl. She doesn't like to take it. Her doctor didn't want her to open the hives and cause impetigo. She never had any soreness in her arm. She doesn't think the headache was serious because she had a blood pressure cuff at home. She just knew the hives and the rash were a reaction to the Covid 19 vaccine. She didn't go to the hospital for her seizures. She was not seen in the Emergency Department, hospitalized, or admitted to an Intensive Care Unit. She tries to do holistic medicines and treatments. She doesn't run to the hospital every time something happens. She tries to stay out of the hospital. She's fine now and she loves Pfizer. If she can get a medicine she needs that Pfizer makes she tries to get it. She tries to see every side of things. Outcome of seizures was recovered on 27Mar2021 and sore muscles was recovered on 28Mar2021; of remaining events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and seizure cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
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| 66 | 2021-04-23 | muscle pain, joint pain |
headache; swollen lymph nodes; muscle/joint pain; joint pain; tiredness; injection site soreness; in...
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headache; swollen lymph nodes; muscle/joint pain; joint pain; tiredness; injection site soreness; injection site swelling; nausea; generally felt unwell; This is a spontaneous report from a contactable Consumer (Patient). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 13Feb2021 16:00 (Batch/Lot Number: EM9809) as single dose for covid-19 immunisation. Medical history included arthritis and overweight from an unknown date and unknown if ongoing. Concomitant medication included meloxicam and zolpidem. On 15Feb2021 08:00, the patient experienced headache, swollen lymph nodes, muscle/joint pain, joint pain, tiredness, injection site soreness, injection site swelling, nausea and generally felt unwell. The action taken in response to the events for bnt162b2 was not applicable. The outcome of event was recovering.
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| 66 | 2021-04-23 | muscle pain |
fever of 101.3; full body muscle pain; headache; vomiting; This is a spontaneous report from a conta...
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fever of 101.3; full body muscle pain; headache; vomiting; This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: 9809; Expiration Date: unknown) via an unspecified route of administration, in Arm Right on 09Feb2021 08:15 for COVID-19 immunization.The patient previously took first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: 3247; Expiration Date: unknown), via an unspecified route of administration, in Arm Right on 19Jan2021 08:15 for COVID-19 immunization. The patient previously took Levaquin and bnt162b2.Medical history included neuropathy peripheral, rosacea, drug hypersensitivity to levaquin. Concomitant medications included vitamins (MULTIPLE VITAMIN), ciclosporin (RESTASIS), calcium and omega 3 taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Feb2021 22:00, the patient experienced fever of 101.3, full body muscle pain, headache, vomiting. The patient underwent lab tests and procedures which included body temperature: fever of 101.3 on 09Feb2021. The outcome of the event was recovered.
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| 66 | 2021-04-24 | joint pain, joint swelling |
blood clot in her right ankle; varicose vein in her right ankle and it started to hurt; varicose vei...
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blood clot in her right ankle; varicose vein in her right ankle and it started to hurt; varicose vein in her right ankle and it started to hurt; ankle on her right side started swelling; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on arm left on 26Feb2021 14:00 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809 and expiry date: 30Jun2021) on left arm on 05Feb2021 for covid-19 immunisation. The patient experienced blood clot in her right ankle, varicose vein in her right ankle and it started to hurt, ankle on her right side started swelling, all on an unknown date. All events caused patient physician office visit. Treatment received for all events. It is reported that she is calling about the Covid 19 vaccine. She wanted to report that she developed a blood clot in her right ankle. She went to the doctor yesterday on 06Apr2021. She would like to add she has no prior history of any type of blood issues. The doctor she saw thought that the blood clot and the Covid 19 vaccine could be related but would not commit to saying so directly. She started having issues about 6 days after the second Covid 19 vaccine. She doesn't exactly remember when, maybe the 04Mar2021 or 05Mar2021. She ignored the issues attributing them to over exercising. She reached a point where she couldn't ignore the issues anymore and went to the doctor. Caller clarifies she has a varicose vein in her right ankle and it started to hurt then her ankle on her right side started swelling. She only payed attention to her ankle when it got worse. The last 3 weeks have been awful. She would like it known that she does not lead a sedimentary lifestyle. She rides her bike 60 miles a week and walks 10 miles a week. She's always moving. This is unusual for her. The doctor she saw diagnosed her with a blood clot and he did a sonogram in his office. She has been prescribed Xarelto 15mg tablets. Take 2 tablets twice daily for the first 21 days then on the 22nd day start taking one 20mg tablet once daily. The patient underwent lab tests and procedures which included sonogram: unknown result on 06Apr2021. The outcome of the all events was unknown.
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| 66 | 2021-04-24 | joint pain, muscle pain, rheumatoid arthritis |
Allergic reaction/Reaction or allergies; Stuffy head; nose began to run and began to sneeze; sneeze;...
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Allergic reaction/Reaction or allergies; Stuffy head; nose began to run and began to sneeze; sneeze; Nasal stuffiness; Seasonal allergies; Rheumatoid arthritis; Joint and muscle pain that are worse; Joint and muscle pain that are worse; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunization; and treprostinil sodium (TYVASO), via resp inhalation from Feb2021 to an unspecified date, at 18-54mug (3-9 breaths), 4x/day for secondary pulmonary arterial hypertension. Medical history included ongoing secondary pulmonary arterial hypertension, ongoing arthralgia, ongoing myalgia, seasonal allergy, and hypertension from an unknown date. Concomitant medications included sildenafil citrate taken for an unspecified indication; and amlodipine besilate taken for hypertension. The patient previously took meloxicam for joint pain. On an unspecified date in 2021, the patient experienced joint and muscle pain that are worse, rheumatoid arthritis and seasonal allergies. The patient had joint and muscle pain for a while, but was worse since starting treprostinil sodium. The event of rheumatoid arthritis was considered as medically significant. The patient had joint and muscle issues (arthralgia, myalgia, and rheumatoid arthritis) that could be debilitating, reported that they were getting better with the Nabumetone. On 29Mar2021, the patient had nasal stuffiness that started when she went on an outing. She felt like she was doing better this week than last week (at time of report). On 31Mar2021, the patient reported that she was having a reaction or allergies. She received her first COVID vaccine on 29Mar2021 and felt fine but woke up on Tuesday (30Mar2021) with stuffy head, nose began to run, and began to sneeze. The action taken in response to the events for treprostinil sodium was unknown. The outcome of the events arthralgia and myalgia was recovering, for rheumatoid arthritis was not recovered, and for other events was unknown. The reporter's causality for the event of myalgia and arthralgia with IH Tyvaso was considered to be possibly related. The reporter did not provide causality for the events of rheumatoid arthritis and seasonal allergy. Case Comment/Senders Comment: The company has assessed the serious adverse event of drug hypersensitivity and rheumatoid arthritis as not related to IH treprostinil and TD-300/A device. Drug hypersensitivity was likely due to administration of COVID vaccine. Rheumatoid arthritis was likely an underlying medical condition in this 66-year-old patient based on an implausible time to onset for the reported event. Information on the lot/batch number has been requested.
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| 66 | 2021-04-24 | joint pain |
swells right under her finger; pain in the center of the palms of her hands and bottom of her feet/ ...
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swells right under her finger; pain in the center of the palms of her hands and bottom of her feet/ achy pain; She couldn't straighten it out or bend it all the way down, it was like it was locked; joint went stiff and the pain; joint went stiff and the pain; Center of her palm has a weird feeling, states she has never had shingles before but imagines that is what the palm of her hand would feel like; Center of her palm has a weird feeling, states she has never had shingles before but imagines that is what the palm of her hand would feel like; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) via an unspecified route of administration at left upper arm 10Mar2021 at 12:30 (66-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included thyroid, and "had stem cells put in her hip". Concomitant medications included ongoing thyroid (ARMOUR THYROID) for thyroid. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) via an unspecified route of administration at left upper arm 17Feb2021 at 14:00 (65-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient previously received the second dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for shingles and felt like we were getting the flu and the next morning was fine. Patient states she had stem cells put in her hip and was (medical office name) for an x-ray to see how it's doing. She showed a nurse practitioner her hand and nurse practitioner said patient needs to report that. Patient states it swells right under her finger, swelling under her middle and ring finger. The joint went stiff and the pain. She can't bend her fingers, it is mostly her ring finger. She couldn't straighten it out or bend it all the way down, it was like it was locked. Following her second vaccine dose she has had pain in the center of the palms of her hands and bottom of her feet. The pain is inconsistent as it comes and goes. The feet pain come and go not bad like the hands. The middle of the palm pain comes and goes and the joint on 1 finger never did get better, it is worse at night and a teeny bit better in the morning. She felt pain in 1 of her feet for a moment yesterday and not continuous like her hand. The left hand is not swelling, the center of her palm has a weird feeling, states she has never had shingles before but imagines that is what the palm of her hand would feel like, it is an achy pain. States she kept telling her husband she has pain in the center of her hands and on the bottoms of her feet and feels like she is about to have a break out and didn't. Patient states it has been a month since she had the 2nd vaccine. States the symptoms all started within 24 hours of the 2nd vaccine. On 07Apr2021, nurse practitioner put a lubricant injection (name unknown) into her hand where the swelling was. Patient was told it was a lubricant that might help, and it has helped some. It is moving a little better today after the injection but she still has pain. Adverse events required emergency room visit and physician office visit. Therapeutic measures were taken as a result of the event "swells right under her finger" and included lubricant injection. The outcome of swells right under her finger, joint stiffness, and joint lock was recovering; other events were not recovered. No follow-up attempts are needed. No further information is expected.
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| 66 | 2021-04-24 | joint pain |
Rash started on r forearm and spread to left arm am currently spreading to chest and legs; Blisters,...
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Rash started on r forearm and spread to left arm am currently spreading to chest and legs; Blisters, what looks like calcium splinters and skin peeling; Peeling skin with pain in joints; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, via an unspecified route of administration, administered in the left arm on 29Mar2021 at 13:00 (Lot Number: LAB-1451-0.7), at the age of 66 years, as a single dose for COVID-19 immunization. Medical history included myasthenia gravis, mixed auto immune diseases, allergies to Valium and Zofran. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included omeprazole, alprazolam, levothyroxine, rivaroxaban (XARELTO), losartan potassium (LOSARTIN), atorvastatin, amlodipine, fluticasone, albuterol (SALBUTAMOL). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, at 12:00 am, the patient developed rash started on (R) forearm and spread to left arm and currently spreading to chest and legs. Blisters, what looks like calcium splinters and skin peeling, peeling skin with pain in joints. The events were reported as non-serious. The events required a physician office visit. No treatment was given for the events. The clinical outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 66 | 2021-04-26 | musculoskeletal pain, weight decreased, musculoskeletal stiffness, back pain |
nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels li...
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nervous; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Back pain, butt and legs hurt, feels like Sciatica; Constipated; Doesn't sleep through the night; Headache lasted for days and days; No appetite, lost 6 pounds in a week; No appetite, lost 6 pounds in a week; Tired; Diarrhea; Nausea; felt like Dumping Syndrome; Stiff neck, like an iron claw; Anxiety reared up; Blacked out; Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 17Mar2021 at 11:30 AM (at the age of 66 years old) (Lot Number: EN6205, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included ongoing anxiety (40 years or more), ongoing depression (46 years ago, at the age of 20), ongoing acid reflux (maybe 25 years), ongoing GERD (maybe 25 years), ongoing Barrett's esophagus (for 12 years), mild to moderate COPD since 2011, gastric bypass (a year and a half ago), and lost 120 pounds. Concomitant medications included bupropion for anxiety depression and omeprazole for acid reflux, both ongoing. The patient previously received flu and tetanus on unspecified dates for immunization and both experienced hard red welt on arm (welt was hard and lasted for 5-7 days). The patient reported no side effects for 12 hours, but a little soreness at injection site on 17Mar2021 at 20:00 (8:00 PM). Her arm wasn't heavy, but she had an awareness of the soreness. She has had life-long anxiety and depression. Several weeks ago (on 26Mar2021), her anxiety reared up, and it could have been due to a family situation. On the 9th day after the first shot, she was having a therapy appointment on the phone and talking about her anxiety, and she got a stiff neck, like an iron claw (26Mar2021 at 10:00 am). It lasted for a couple of 5 minutes and she laid down on the couch then on the floor. Her therapist said to call 911. Emergency medical technicians came to her house and they said all of her numbers looked good. She went to the hospital, and was in the emergency room for several hours, but she only remembers one hour of it. She also had diarrhea and nausea on 26Mar2021 at 11:30, and it felt like Dumping Syndrome, that one can have from a gastric bypass. She was only aware for one hour at that point and blacked out (on 26Mar2021). With regards to nausea, she mostly saw bile in the bag, all she had that day was a protein drink. She was back home and the next day, she did not remember how she got home. She hasn't had blackouts anymore but feels it may be from heightened anxiety. On 27Mar2021 at 09:00, she had no appetite, lost 6 pounds in a week, and was tired. She had headache lasted for days and days on 29Mar2021 at 09:00 AM. She is slowly improving but she still doesn't sleep through the night on 29Mar2021 at 16:00. It was like a feeling like she was resetting her surgery, like she didn't care about eating. The also experienced back pain, butt and legs hurt, feels like sciatica on 31Mar2021 at 16:00 and was constipated. She is using a stool softener and is back in her routine. She called her primary doctor and could not tell her what happened, and she went in a loop trying to get information and authorizations for her to make a determination of what had happened. Her doctor felt like she should have an MRI. Her heart and all of her numbers looked good, as the emergency medical technicians said. Her primary doctor recommended her to get the second shot. She had cancelled the second shot for this week, and she has rescheduled it for another date. She was afraid that she will black out again, after the next vaccine, and is not sure if that is how her anxiety manifested. The main reasons she is calling is that she had no concerns of side effects prior to the vaccine, and a couple of her neighbors said they had read about side effects of the vaccine, but she was not worried. When the patient started to read about side effects of the vaccine, she understood that on the 10th day, the vaccine starts to be in a person's system and that maybe is why she didn't have initial side effects, but then she had side effects several days later because the vaccine was in her body. By day 10, the vaccine is in effect in the body and she is nervous. Her second vaccine is scheduled on 26Apr2021. The patient would like to know if there is any information on people that have had a gastric bypass. The patient has no prior vaccinations within 4 weeks. The events resulted in emergency room visit (except nervous). The patient recovered from soreness at injection site on 18Mar2021; recovered from diarrhea, nausea, felt like Dumping Syndrome on 26Mar2021; recovered from stiff neck on 26Mar2021 at 10:05am; recovered from constipation on 02Apr2021; and recovered from no appetite and lost 6 pounds on unspecified dates. The patient also recovered from headache with sequelae on unspecified date; and recovered from blacked out on 27Mar2021 with sequelae. The patient had not yet recovered from anxiety reared up; tired; doesn't sleep through the night; back pain, butt and legs hurt, feels like sciatica. No follow-up attempts are possible. No further information is expected.
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| 66 | 2021-05-06 | back pain, weight decreased |
Significant weight loss; Chronic back pain; terrible pain in the back; Osteolysis; Terrible pain in ...
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Significant weight loss; Chronic back pain; terrible pain in the back; Osteolysis; Terrible pain in her extremities; It was her first dose and she was afraid to get the second one now; patient was supposed to get her second one last week and she didn't; Paralyzed from her neck down to her arm, legs, and everything; weakness in extremities; could not move; Received BNT162B2 via subcutaneous route; This is a spontaneous report from a contactable nurse (patient who is a retired nurse who did anesthesia). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), subcutaneous in right deltoid of the upper arm, on 09Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history included pain, use of medication to help with sleep, gastroesophageal reflux disease (GERD), and thyroid. The patient's concomitant medications included levothyroxine for thyroid, pantoprazole sodium sesquihydrate (PROTONIX) for GERD, trazodone to help with sleep, zolpidem tartrate (AMBIEN) to help with sleep, morphine (extended relief) for pain, and morphine sulfate (immediate relief) for pain. They also gave the patient diazepam (VALIUM) if she needs to take it but she did plan; she didn't take it. The patient just didn't take diazepam and then pain management doctor put her on morphine extended release. Then, morphine sulphate immediate relief, so she can take up to 4 for day and she was not using now. The COVID-19 vaccine was administered in a pharmacy. The patient would like to report a reaction that she received that she had approximately for an hour and a half, that basically started in an hour after the injection. The patient's first COVID-19 shot was given by Pfizer on 09Mar2021 and what happens in next hour was she became totally paralyzed from her neck down to her arm, legs, and everything. It was approximately about 30 minutes after the shot that she began to notice some weakness in extremities (also reported as eternities) and then they got home an hour later, and her husband left the patient then she got to know she could not move. The patient can breathe, and she was totally conscious, but she could not move, could not pull herself along the floor, could not pull from the sofa, could not move her knee, and could not move her body. So, the patient thought maybe she should report this. On an unspecified date, the patient had significant weight loss. The patient was eating but she was rapidly losing. The patient didn't have COVID-19; she had been tested negative, so she didn't have COVID-19. The patient was tested 4 times for her to be around her grandchildren and make sure everything is okay. The patient had been tested against COVID-19 because of her grandchildren. The patient tried to take them, and she just now received the paper it was negative. So, it was her third one to try to watch her grandchildren because they were infant, and all test results were negative. It was also reported that the patient had no other problem, just the pain clarified as chronic back pain since an unspecified date. The patient checked this as persistent for chronic back pain; it is positive, definitely it's totally osteolysis on an unspecified date. Treatment was received for all events (unspecified medications). The patient went to her primary healthcare doctor as a result of the events and he said it was no big deal and she told him that she disagrees with that. Trazodone was added to zolpidem tartrate to help w with the sleep because she had terrible pain in the back (right here) and her extremities after this incident (unspecified date). It was her first dose and she was afraid to get the second one now. The patient was supposed to get her second one last week and she didn't. So, they told her to come back in 3 weeks or 4 weeks. The patient underwent laboratory test back in December (unspecified year). The patient recovered from "Paralyzed from her neck down to her arm, legs, and everything; weakness in extremities; could not move" on 09Mar2021. The patient had not recovered from "Chronic back pain; terrible pain in the back". The outcome of the other events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: A contributory role of BNT162B2 to event paralyzed from her neck down to her arm, legs, and everything cannot be excluded based on close temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 66 | 2021-05-12 | neck pain, muscle pain | Neck muscles still sore since 2/2021 |
| 66 | 2021-05-17 | back pain |
Heaviness in Breathing/breathing problems; felt different; not feeling good; Aggravated Asthma; horr...
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Heaviness in Breathing/breathing problems; felt different; not feeling good; Aggravated Asthma; horrible acid reflux/ Aggravated Acid reflux; was in pain last night/she was really hurting; blood pressure was sort of up to like 185 over 186; Chest pain; back for stabbing pain; Pressure chest; Wheezy; This is a spontaneous report received a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not reported), via unspecified route of administration in the left arm on 01May2021 (at the age of 66 years-old) as a single dose for COVID-19 immunization. The patient's medical history included a "heart condition", asthma, acid reflux, hiatal hernia, and being "allergic to a lot of medications", reporting that she previously had to carry an epinephrine (EPIPEN). The patient had unspecified concomitant medications. The patient stated that immediately after the first dose, she started not feeling good (01May2021), and by the time she got home, she was really having some breathing problems (01May2021). She was monitored at the vaccination site for 30 minutes after administration, but did not report to them, because she did not know what to tell them. She a history of asthma, so she treated with her inhalers, and "it eased off a little bit". She reported she was really hurting, so she took a 5 mg dose of prednisone tablet. She also reported horrible acid reflux later that night (01May2021), which can trigger her asthma, she took some aluminum hydroxide/ magnesium hydroxide/ simethicone MYLANTA and felt much better. She slept propped up, took another dose of MYLANTA this morning, and was feeling better today, but not 100%. She wanted to know if the vaccine can cause acid reflux or asthma exacerbations? And if she should expect the same, but more severe reactions after the second dose? It was also reported, that after the vaccine, the patient stated for fifty minutes maybe she had what was like pressure in her chest (unspecified date May2021). She did not know what she was feeling, so she did not say anything. So she came home, and just as the day got work more the pressure, she had asthma and saw what was happening was an asthma attack, which started hurting really bad like an asthma attack, so she took her inhalers, and it eased it off a little bit. Then it just kept worsening. She was also a heart patient, so when she had asthma, some times it mimicked a chest pain. She was thinking if it was affecting chest pain or was it asthma, so had some prednisone, 5mg of prednisone (treatment) that she had to take for her asthma. It did not help last night (further clarification unknown). She was trying to get to the hospital. She was wondering if this shot had aggravated her acid reflux and aggravated her asthma (both 01May2021). When the patient went to bed, she got some aluminum oxide/ magnesium hydroxide (MAALOX), big dose of MYLANTA, and that eased it off. Before she got the shot, she felt fine; she would have no symptoms, and then when she got the shot "mean it went 30 minutes later and I just felt this and I still did not know what it was". Her husband told her to sit down. She did not know what was wrong, she just felt different. She thought it caused her asthma to act up. The patient stated that last night (01May2021), her blood pressure was sort of up to like 185 over 186, "but I think it was because I am extreme so bad by then I am and my chest in my chest and then I finally said okay let me take so (incomplete sentence) my acid reflux so let me take some MYLANTA so I take calcium carbonate/ magnesium hydroxide (ROLAIDS) and I immediately stop that pain that must be my acid reflux making triggering my asthma it is, I was like, I was in pain last night (01May2021), just administered for my asthma between my chest and my back for stabbing pain (01May2021) and that caused sometimes when I have heart condition, I always like it is my heart or it is my asthma what is it? and I got this one okay I will take a dose of MYLANTA just to make sure see that will help come down". The patient felt a lot better today, but still felt sort of wheezy (May2021) "like you know when you have asthma". Her bad asthma she would just get a wheezy sort of just heaviness in breathing. The patient was due to get the second shot on 22May2021. On an unspecified date, the patient had: a lab test "but have results before I had the following to chest by giving lastly", and routine blood work-cholesterol and all. The outcome of the events wheezy, heaviness in breathing/ breathing problems, horrible acid reflux/ aggravated acid reflux was recovering. The outcome of other events was unknown. Information about lot number has been requested.
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| 67 | 2021-01-04 | joint pain |
54 hours after injection SEVERE joint pains (including to touch) lasting overnight; This is a sponta...
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54 hours after injection SEVERE joint pains (including to touch) lasting overnight; This is a spontaneous report from a contactable nurse (patient). A 67-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in the right arm in Dec2020 04:30 PM at a single dose for COVID-19 immunization at the hospital. Medical history included gastric distress from cow milk products, and allergies to statins, dust/ dust mites. Concomitant medications included loratadine, boswellia serrata (BOSWELLIA), famotidine (PEPCID), and vitamin C. The patient did not received other vaccine within four weeks of COVID vaccine. The patient previously took ciprofloxacin (CIPRO) and experienced allergies. The patient has not been diagnosed of COVID prior vaccination and has not been tested for COVID post vaccination. It was reported that on 23Dec2020 20:00, 54 hours after injection, the patient had severe joint pains (including to touch) lasting overnight. The event was partially improved with Tylenol, loratadine, Benadryl, boswellia; and subsided next day. Outcome of the event was reported as recovering. The event was assessed as non-serious.
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| 67 | 2021-01-05 | joint pain |
severe headache, fever, nausea, frequent bowels, injection site pain, chills, joint pain - it felt l...
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severe headache, fever, nausea, frequent bowels, injection site pain, chills, joint pain - it felt like 36 hours of bad flu
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| 67 | 2021-01-07 | neck pain | headache, nausea, light sensitivity, neck pain, general not feeling well, not sleeping well |
| 67 | 2021-01-13 | limb discomfort |
Left hand in thumb area and Left wrist patient reported a twinge feeling and was very warm. Blood ...
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Left hand in thumb area and Left wrist patient reported a twinge feeling and was very warm. Blood pressure was 126/80, pulse ox 95 and pulse 73. Gave patient H2O and patient sat another 15 minutes. Left with no more symptoms and vital signs were 120/78, pulse ox 94 and pulse 75
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| 67 | 2021-01-14 | joint pain |
received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am. Awoke at 12 midnight unable to hersel...
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received Pfizer vaccine on 1/11/2021 in Right arm at 9:40 am. Awoke at 12 midnight unable to herself out of bed, needed to wake husband for assistance due to employee being unable to use Right arm. Developed headache, chills, sweats, joint pain Stated "it felt like I was hit by a bus" felt like I got beat up. Wednesday Headache was gone, R arm swollen, lymph nodes at axilla and R neck large as grapes, painful. No appetite, effort to move .Arm was swollen and reddened at injection site.
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| 67 | 2021-01-14 | joint pain |
INJECTION WAS ADMINISTERED IN THE CLAVICULAR SECTION OF THE L DELTOID: TINGLING AND HEAVINESS AT SIT...
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INJECTION WAS ADMINISTERED IN THE CLAVICULAR SECTION OF THE L DELTOID: TINGLING AND HEAVINESS AT SITE RADIATING DOWN THE ARM TO HAND AND INTO THE L SHOULDER (I BELIEVE IT WAS GIVEN TOO CLOSE TO THE NERVE: THIS RXN R/T VACCINE DELIVERY TECHNIQUE; RXN TO VACCINE ITSELF: 32 HOURS AFTER ADMIN, CHILLS, SEVERE ARTHRALGIAS THAT LASTED 12 HOURS AS WELL AS SUSTAINED HEADACHE AND SACRUM ACHE FOR 4 DAYS
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| 67 | 2021-01-15 | muscle pain | Headache, Myalgia, fatigue |
| 67 | 2021-01-17 | muscular weakness |
States was very fatigued day of vaccination. Day after vaccination states bilateral feet were numb a...
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States was very fatigued day of vaccination. Day after vaccination states bilateral feet were numb and hands felt weak. Did not seek any medical attention. Entirely resolved day of reporting this (1/18/21).
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| 67 | 2021-01-20 | muscle pain, joint pain |
Sore muscle at injection site, fatigue, joint pain; Sore muscle at injection site, fatigue, joint pa...
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Sore muscle at injection site, fatigue, joint pain; Sore muscle at injection site, fatigue, joint pain; Sore muscle at injection site, fatigue, joint pain; Sore muscle at injection site, fatigue, joint pain; This is a spontaneous report from a contactable nurse (patient). A 67-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration on 07Jan2021 09:45 at single dose for covid-19 immunization. Vaccine location was left arm. Patient received the first dose on 17Dec2020 08:45 AM (lot number EK5730) at right arm for covid-19 immunization. Patient is not pregnant. The facility type vaccine was hospital. Medical history included hypertension, elevated cholesterol. Known allergies included Sulfa. Concomitant medication included losartan, hctz, atorvastatin, zinc, ergocalciferol (VIT D). Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore muscle at injection site, fatigue, joint pain on 07Jan2021 10:00 AM. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in Jan2021.
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| 67 | 2021-01-21 | joint pain |
General malaise with burning sensation inside the body, no fever registered; inflammation of right a...
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General malaise with burning sensation inside the body, no fever registered; inflammation of right arm and hand/wrist, migratory joints pains, muscle pain, stabbing pains sudden, neuralgic pain in the extremities. Pain was so severe that cause limitation for walking around the house. The last event on the 7th day was inflammation of the right foot and ankle with severe pain with no history of sprain or trauma.
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| 67 | 2021-01-22 | limb discomfort |
Left Arm reddness and hot to touch, red circle 5 inches wide - Approx 4 hr following injection (5:30...
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Left Arm reddness and hot to touch, red circle 5 inches wide - Approx 4 hr following injection (5:30PM 1/21/21) Fever 102 at 10PM : Aleve 2 gelcaps for fever and arm discomfort , also used heating pad on Left arm discomfort Woke at 5 AM TEMP 102.2 , arm much better, vertigo significant, took mezcalin anti vertigo RX (had from from weeks virus) took 1 Aleve gelcap Temp assessed at 2PM - 99.2 Temp assessed at 5PM - 98 No anti pyretic taken after5am
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| 67 | 2021-01-23 | joint pain, muscle pain |
Within 2 hours of receiving my second Covid 19 vaccine I developed fever, chills, nausea, vomiting, ...
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Within 2 hours of receiving my second Covid 19 vaccine I developed fever, chills, nausea, vomiting, myalgias, arthralgias which persisted for 36 hours. After 36 hours, the acute symptoms improved, but I have had persistent daily fever, sweats, chills. The fever has been as high as 102 degrees F orally. The night sweats have been extremely drenching. I also have had ongoing fatigue and have been unable to work or perform my usual activities.
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| 67 | 2021-01-24 | joint pain | fever (100.4 - 100.9). chills, achy joints, fatigue, nausea |
| 67 | 2021-01-25 | joint pain, musculoskeletal stiffness |
My left elbow and shoulder blade felt sore/stiff. The shoulder blade got better but the left elbow ...
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My left elbow and shoulder blade felt sore/stiff. The shoulder blade got better but the left elbow still bothers me. Nothing terrible and not all he time. Feels kind of like a stiff neck but in the elbow.
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| 67 | 2021-01-25 | musculoskeletal stiffness | Within 15-minutes of vaccination, patient complained of a stiff neck. |
| 67 | 2021-01-27 | joint pain, muscle pain |
Nausea; muscle pain; joint pain; headache; tiredness; This is a spontaneous report from a contactabl...
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Nausea; muscle pain; joint pain; headache; tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248 and expiry date: Apr2021), via an unspecified route of administration on the left arm, on 12Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included high blood pressure; patient was not pregnant at time of vaccination. Concomitant medications were unspecified (received within 2 weeks of vaccination). The patient experienced nausea, muscle pain, joint pain, headache and tiredness on 13Jan2021 14:00. Treatment was not received for the events. Patient was recovering from the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 67 | 2021-01-27 | musculoskeletal discomfort | Within 15-minutes of vaccination, the patient reported pruritus on their neck and chest. |
| 67 | 2021-01-28 | joint pain, muscle pain |
redness and swelling at injection site; redness and swelling at injection site; muscle pain; muscle ...
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redness and swelling at injection site; redness and swelling at injection site; muscle pain; muscle and joint pain; not feeling well; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) at the 1st dose on 22Dec2020, at the 2nd dose on 12Jan2021; both via an unspecified route of administration at left arm at single dose for covid-19 immunization. Medical history included diabetic and allergies to sulfur drugs. Concomitant medications included other medications in two weeks. The patient was not pregnant. The patient had no other vaccine in four weeks. The patient experienced redness and swelling at injection site, muscle pain, muscle and joint pain, and not feeling well on 24Dec2020. No treatment was received for events. The patient had no COVID prior vaccination. The patient had Covid test post vaccination by Nasal Swab on 11Jan2021 with negative result. Outcome of the events was unknown.
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| 67 | 2021-01-28 | joint pain |
Night 3 of vaccine woke in am with right mild thigh gnawing, a sensation never experienced before....
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Night 3 of vaccine woke in am with right mild thigh gnawing, a sensation never experienced before. Duration 1-2 hours. Night 4 woke 2 am with more intense discomfort left knee, again not like anything experienced before but did not require Tylenol. It was gnawing and annoying, Night 5 woke around 4 am with left lower leg/ side of foot mild ache which lasted a few hours. Stretching, changing positions had no effect on any of three nights. Day after vaccine while exercising I perspired more than usual and was tired. Did not concern me in any way and would not have reported unless had above symptoms. Question- Do any of the above symptoms indicate I should not get dose 2? Thank you
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| 67 | 2021-01-29 | muscle pain | Headache, muscle ache, severe chill, fever |
| 67 | 2021-02-01 | flank pain |
During the evening of the day that the vaccine was given, patient had pain in right flank. Pain les...
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During the evening of the day that the vaccine was given, patient had pain in right flank. Pain lessened the next day. That second night at about 3:00 AM, she was awakened by severe pain in the same area. The next day, she went to her physician. By that time, she had a rash in the right flank area. Her physician diagnosed shingles and prescribed Valtrex. The Valtrex , along with ice, subdued her pain. and after 2 weeks, her symptoms resolved.
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| 67 | 2021-02-01 | muscle pain |
nausea; vomiting; rigors; temperature greater than 100 degrees topical; headache; muscle ache; This ...
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nausea; vomiting; rigors; temperature greater than 100 degrees topical; headache; muscle ache; This is a spontaneous report from a contactable health care professional nurse, the patient. A 67-years-old non-pregnant female patient (nurse) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot Number: EK9231,), intramuscular in the left arm on 07Jan2021 16:00 as a single dose, for COVID-19 vaccination. Medical history included gastrooesophageal reflux disease. Concomitant medication included diltiazem (DILTIAZEM). Patient has no known allergies. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number EH9899, on 18Dec2020; 16:00, Intramuscular, right arm,. On 08Jan2021 at 04:00 the patient experienced nausea, vomiting, rigors, temperature greater than 100 degrees topical, headache, muscle ache. The events resulted in a Physician office visit. Lab tests included body temperature: greater than 100 degrees on 08Jan2021. Treatment given include zofran, APAP, fluids, and rest. The clinical outcome of nausea, vomiting, rigors, temperature greater than 100 degrees topical, headache, muscle ache was recovering.
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| 67 | 2021-02-02 | bone pain |
Beginning 4 hours after administration of 2nd dose: headache, malaise, fatigue By 10 hours after dos...
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Beginning 4 hours after administration of 2nd dose: headache, malaise, fatigue By 10 hours after dose: worsening headache, low grade fever, body pain By 24 hours after dose: above symptoms continued, but now had bone pain By 48 hours after 2nd dose was "back to normal"
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| 67 | 2021-02-03 | joint swelling, joint pain |
3 days following vaccine, experienced tenderness and discoloration in left hand. With it was tendern...
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3 days following vaccine, experienced tenderness and discoloration in left hand. With it was tenderness in my hand and wrist, by the 3rd day, I woke with throbbing pain in my knuckle joint with swelling and redness. Since then, the swelling and pain has progressed to additional knuckles in my left hand and into my right hand. There has also been joint pain in my left shoulder that resolved. Yesterday my right knee began to hurt. I've used ice packs and alternated between ibuprofen and acetaminophen for the pain. The swelling has somewhat improved but has not resolved. The pain is still present. I've had occasional join pain before but nothing like this and it has always resolved. Not sure if this has anything to do with the vaccine, but since joint pain was listed as a side effect, I thought I should report it. Have not contacted my physician yet.
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| 67 | 2021-02-04 | muscular weakness |
bilateral feet were numb and hands felt weak; bilateral feet were numb and hands felt weak; fatigued...
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bilateral feet were numb and hands felt weak; bilateral feet were numb and hands felt weak; fatigued; This is a spontaneous report from a contactable Nurse (the patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1685, expiration date unknown), intramuscularly in the left arm, on 28Dec2020 as a single dose for COVID-19 vaccination. Medical history was not reported. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 28Dec2020 the patient experienced fatigue. On 29Dec2020 the patient states that her feet were numb bilaterally and her hands felt weak. The patient did not seek any medical attention and no treatment of the events was reported. The clinical outcome of fatigue, numbness of feet and weakness of hands was recovered (reported as "resolved entirely on its own") on an unspecified date.
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| 67 | 2021-02-05 | joint pain, muscle pain |
Fever of 100, chills, muscle and joint aches and a headache began about 2:00 am, throughout the day ...
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Fever of 100, chills, muscle and joint aches and a headache began about 2:00 am, throughout the day on Friday the aches increased. Slept quite a lot. Took Tylenol and Advil, alternating them and then at bedtime took 1 of each. Joint aches have decreased on Saturday, but the fever and chills are still coming and going.
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| 67 | 2021-02-06 | muscle pain, joint pain | Fever, headache, muscle pain, chills, joint pain, fever. |
| 67 | 2021-02-07 | joint pain, muscle pain |
Medical history included systemic lupus; Medical history included systemic lupus; Fever; Vomiting; D...
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Medical history included systemic lupus; Medical history included systemic lupus; Fever; Vomiting; Diarrhea; Abdominal pain; Joint/muscle pain; Joint/muscle pain; Nausea; Fatigue; Severe headache; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration in the right arm on 15Jan2021 13:00 at SINGLE DOSE (first dose) for COVID-19 immunization. Medical history included systemic lupus, "hypothyroid", Leiden Factor V. Patient's known allergies: penicillin, erythromycin and tetracycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included hydroxychloroquine, clopidogrel bisulfate (PLAVIX), acetylsalicylic acid (ASPIRIN), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity, tetracycline and experienced drug hypersensitivity. On 15Jan2021 16:00, the patient experienced fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm. Outcome of events was fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm not recovered. Outcome of the other events was unknown. Patient did not receive any treatment for the events. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
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| 67 | 2021-02-08 | joint pain, neck pain |
Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unw...
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Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unwell; Difficulty sleeping; Dizziness; Weakness; Joint pain neck; Joint pain neck; Mild injection site pain; This is a spontaneous report from a contactable nurse reporting for self. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history included Covid, Hypothyroidism, Arthritis, Chronic Neck R shoulder pain, Migraines, Submaxillary gland removal, Tubal ligation. Concomitant medication included amitriptyline, ibuprofen, levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN [IBUPROFEN]), vitamin d3. Patient received first dose of bnt162b2 on 30Dec2020 and experienced injection site pain. Patient had allergies to Amoxicillin, Duricef, Mobic, Nexium. The patient experienced severe chills, feeling unwell, difficulty sleeping, dizziness and weakness, passed out, laceration to back of skull requiring staples, joint pain neck, mild injection site pain, on 22Jan2021 01:00 AM, 24 hours later rash on torso. Patient underwent CT head neck, EKG, Chest XRAY, Labs, results all unknown. Events resulted in Emergency room/department or urgent care. Outcome of event rash was unknown, of other events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for passed out and chills. Laceration is subsequent to passed out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-02-08 | joint pain |
8 hrs post vaccine, got headache, chills, no fever, felt like the worst flu I ever had for 12 hrs, ...
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8 hrs post vaccine, got headache, chills, no fever, felt like the worst flu I ever had for 12 hrs, felt slightly better but still quite ill, tired, joint ad body aches, headache. Could not eat or get out of bed
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| 67 | 2021-02-08 | muscle pain, joint pain |
Nausea, a bit of headache immediately after receiving vaccine. The next day extreme fatigue, some pe...
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Nausea, a bit of headache immediately after receiving vaccine. The next day extreme fatigue, some periods of weakness, muscle ache, joint ache, a bit of nausea and headache; soreness, swelling, and redness at injection site; intermittent itching at injection site and upper body
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| 67 | 2021-02-09 | musculoskeletal stiffness, muscle pain |
Muscle pain left arm 20 hours; Left foot felt like electric shock, vibrated and was stiff and out of...
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Muscle pain left arm 20 hours; Left foot felt like electric shock, vibrated and was stiff and out of control for 7 times; Left foot felt like electric shock, vibrated and was stiff and out of control for 7 times; Left foot felt like electric shock, vibrated and was stiff and out of control for 7 times; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: E19262 and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included peanut allergy. Patient was not pregnant at the time if vaccination. There were no concomitant medications. The patient experienced muscle pain left arm for 20 hours. Pain in arm muscle only when moving arm. Her left foot felt like electric shock, vibrated and was stiff and out of control for 7 times during same time as arm pain. Each episode lasting only 2 to 3 seconds. The events happened on 21Jan2021 12:00. Patient recovered from the events and had not received any treatment. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 67 | 2021-02-10 | bone pain |
Four day incapacitation;followed by 3 days of lessening symptoms of fever, bone and body ache, weakn...
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Four day incapacitation;followed by 3 days of lessening symptoms of fever, bone and body ache, weakness , headache, mental confusion, diahrea and dehydration
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| 67 | 2021-02-10 | muscle pain |
The same day as receiving the vaccine, I started getting nervous and restless around 11pm after I we...
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The same day as receiving the vaccine, I started getting nervous and restless around 11pm after I went to bed. I started having generalized pain, all my muscles became achy and my R arm was so sore I could not move it. About 1 am the next morning, I became nauseated and retching. I stared sweating and chilling, my body was shaking so bad I could not hold my thermometer. That lasted possibly 5 minutes, fever 100.8. Episodes of sweating alternating with cold chills occurred the remainder of the night. Exhaustion set in and I could not get out of bed. I was on bedrest all morning and I began to feel better around 4-5pm the next day.
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| 67 | 2021-02-11 | joint pain |
Pfizer COVID19 vaccine, part 1. Nausea for more than 10 days, sharp pain in ankle and knee joints f...
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Pfizer COVID19 vaccine, part 1. Nausea for more than 10 days, sharp pain in ankle and knee joints for 3 days.
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| 67 | 2021-02-11 | muscular weakness |
On Christmas day I was working and then you started feeling like a pinching in my chest, like when y...
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On Christmas day I was working and then you started feeling like a pinching in my chest, like when you are going to catch a cold, that went on through the afternoon. In the afternoon I started with light headache and dry cough (intermittent), no temperature. I did not take anything for it and continued working. When I got home, I felt weak and was supposed to join my family for Christmas and decided not to go. And went to sleep. The next day (Sat) I was still not feeling well, weakness on my limbs, I went to the hospital to see if I could get checked and they told me to return on Monday because Occupational Health was closed on the weekends. I went home and treated myself with Tylenol and Vitamin C. On Monday I got tested and was positive. By then, I was coughing, limbs weak, had temperature (101F). I started to get weaker an weaker and Tuesday or Wednesday my work called me and asked me if I would like to come see a doctor. Wednesday I started with shortness of breath. I called my PCP and he prescribed me an albuterol inhaler. It helped me but my cough got worse by Saturday. My doctor then told me to go to the hospital (I live by myself). At my choice I went to Medical Center and were admitted and was hospitalized for 6 days. They kept treating me with inhaler and oxygen. They wanted to send me to rehab but I told them I wanted to go home. I came home with oxygen and with albuterol inhaler and the ambulance had to bring me home. I still was feeling very weak, had cough, and had the shortness of breath. And I have been home since then. I have home health and a therapist that come check on me 2X a weekly.
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| 67 | 2021-02-14 | joint pain |
At 8pm arm started to swell up to shoulder; at 11:30 pm neck became numb up to jaw top of chest, arm...
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At 8pm arm started to swell up to shoulder; at 11:30 pm neck became numb up to jaw top of chest, arm was hard and soar to wrist. couldn't make fist. joints throbbing. foot swollen and couldn't lift up arm. Feeling like getting flu. Most symptoms lasted 1 week- last reported 2/11/2021.
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| 67 | 2021-02-14 | joint pain |
Joint pain in hands; This is a spontaneous report from a contactable consumer (patient). A non-pregn...
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Joint pain in hands; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 26Jan2021 at 11:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history included high blood pressure and depression. The patient was taking unspecified concomitant medications. The patient previously took codeine and experienced allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 at 01:30 AM (approximately 14 hours after injection), the patient experienced joint pain in hands. The event was considered non-serious. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event on 27Jan2021. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
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| 67 | 2021-02-14 | muscle pain | Myalgias, fatigue, headache, weakness, nausea, chills, decreased appetite and easy bruising. |
| 67 | 2021-02-14 | muscle pain |
The 2nd dose was received on 06-02-21. The next day I had muscle pain and intense cold. Two days lat...
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The 2nd dose was received on 06-02-21. The next day I had muscle pain and intense cold. Two days later I got a rash on my vaccinated arm. Five days later, my body gradually filled with a rash and itching that appeared first on the chest, then neck and face, then on the back and abdomen and went down to the thighs and finally on the feet and soles of the hands. Yesterday 02-14-21 I went to the emergency service at Hospital, after being examined, the diagnosis was an allergic reaction to the vaccine I was prescribed a steroid and anti-allergy. Today is the ninth day after receiving the 2nd dose of the vaccine and I still get the rash and itchy
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| 67 | 2021-02-15 | back pain, muscle pain |
I received the shot on Feb. 13, 2021. My side effects started on February 14 before bedtime and cont...
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I received the shot on Feb. 13, 2021. My side effects started on February 14 before bedtime and continued through the day on February 15. I felt much better on Tuesday, symptom free. Pain at shot site and in muscles beginning about 1 hour after the shot and got worse for the next several hours. I began to be very tired before bedtime and started a headache, a fever of about 99.6, and chills. Chills throughout the night on Feb. 14 until morning the 15th. Felt achy in back and general aches all day the 15th and headache. Fever Feb. 15 when I got up in the morning was 100.2. Just sat around very tired and achy throughout the day on Feb. 15. Still a slight fever that night (99.3), but I began to start feeling better close to bedtime on Feb. 15. Feb. 16- I feel fine, just a bit tired, but doing my normal activiites.
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| 67 | 2021-02-16 | musculoskeletal stiffness, joint pain |
Possible flare of RA. Symptons include fatigue, pain and stiffness in joints; parficularly right sh...
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Possible flare of RA. Symptons include fatigue, pain and stiffness in joints; parficularly right shoulder.
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| 67 | 2021-02-17 | joint swelling |
Wrist bone is swollen on the right arm where she received vaccine; This is a spontaneous report fro...
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Wrist bone is swollen on the right arm where she received vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration in the right arm on 29Jan2021 16:00 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. On 29Jan2021 19:00, the patient experienced that wrist bone was swollen on the right arm where she received vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 14Dec2020. No therapeutic measure was taken as a result of the events. Clinical outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 67 | 2021-02-17 | muscle tightness |
Patient received first dose of Pzifer Vaccine. Approximately 20 minutes later developed tightness t...
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Patient received first dose of Pzifer Vaccine. Approximately 20 minutes later developed tightness to her posterior neck and shoulders. Encouraged to remain for full 30 minutes, patient continued to report these symptoms. Patient evaluated by RN Observers, denies shortness of breath, mouth/tongue swelling, palpitations, itching, rash. Patient given 25mg PO Benadryl from Vaccine Clinic RN. Patient reported she maybe was a little light headed and anxious so she laid down. About 10 minutes after she reported feeling some better and wanted to go home. Patient counseled by RN, Resource Nurse on signs and symptoms to watch for and when she should call 9-1-1 if symptoms worsen.
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| 67 | 2021-02-17 | muscle pain, armpit pain, joint pain, back pain |
Day after shot woke up with muscle aches, joint pain and extreme fatigue until early evening, then s...
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Day after shot woke up with muscle aches, joint pain and extreme fatigue until early evening, then symptoms went away. One dose 200mg Ibuprofen taken during that time. Injection site was sore, sl edematous and red, stayed red for approx 4 days. About a week later, noted pain and what felt like swelling in L armpit, along with muscle pain in back /shoulder area , front of chest and interior muscle of L arm, thought maybe it was just muscle strain, despite not having done anything excessive. Pain continued to get worse over next 5 days, requiring regular doses of pain medication to relieve discomfort somewhat. As of today, general pain and sore muscle pain is approx 50% improved. After researching symptoms, realized it may be vaccine related.
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| 67 | 2021-02-17 | muscle pain |
Serious chills at night of injection, causing me to wake up and take a hot bath; intense headache la...
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Serious chills at night of injection, causing me to wake up and take a hot bath; intense headache lasting from night around 6pm until about 4pm the next day, finally too 100mg Tylenol at 1pm the next day, which helped; aching in muscles throughout the night and morning of the next day, including injection site; cramping in extremities on night of injection (hot bath solved this).
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| 67 | 2021-02-23 | joint pain, muscle pain |
Bitter taste in mouth immediately after shot. A few hours later bad headache, nausea, injection sit...
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Bitter taste in mouth immediately after shot. A few hours later bad headache, nausea, injection site pain and redness and swelling , tiredness, muscle and joint pain, slight fever, feeling unwell. Lasted 5 days.
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| 67 | 2021-02-24 | armpit pain, back pain |
Strong pain on the left arm, between back and scapula, and axillary pain. I only had taken acetamino...
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Strong pain on the left arm, between back and scapula, and axillary pain. I only had taken acetaminophen. Having a slow recovery. Today, 4th day after the vaccination with second dose still have pain but is lower.
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| 67 | 2021-02-25 | joint pain, muscle pain |
Muscle aches, chills and severe joint pain 9:05PM Treatment: went to bed at 10:00 P Following day 2/...
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Muscle aches, chills and severe joint pain 9:05PM Treatment: went to bed at 10:00 P Following day 2/25/2021: 7:45 AM extreme fatigue, loss of appetite, taste buds off Treatment: naps, fluids 02/25/2021 9:00PM mild muscle aches and joint pain
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| 67 | 2021-02-25 | limb discomfort |
I really hurt so bad all over; I hurt all over like right leg, left leg, upper body; Headache; My ar...
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I really hurt so bad all over; I hurt all over like right leg, left leg, upper body; Headache; My arm was just little uncomfortable; patient with fibromyalgia was given Pfizer Covid-19 Vaccine; patient with fibromyalgia was given Pfizer Covid-19 Vaccine; I am getting nightmares, it's like I am struggling; Fibromyalgia/never have 'flare-up' this bad; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL1283; expiration date: unknown) at 67-year-old age of vaccination via an unspecified route of administration in the left arm on 21Jan2021 at a single dose for covid-19 immunization. Medical history included fibromyalgia. The patient's concomitant medications were not reported. The patient reported that she got her vaccine on a 21Jan2021 (Thursday) and on Friday (22Jan2021), her arm was just little uncomfortable but its fine. On Saturday by 4 o' clock (23Jan2021), she really hurt so bad all over and with headaches. By Sunday (24Jan2021), it went down a little bit and it was going away but last night (unspecified date in 2021), it hit again it just waking her up and she was getting nightmares, it's like she was struggling. She mentioned that she has a history of Fibromyalgia, but she never has 'flare-up' this bad on unspecified date in 2021. It was reported that the patient with fibromyalgia was given Pfizer Covid-19 Vaccine. She further stated that she hurt all over like right leg, left leg, upper body. The patient received treatment of acetaminophen (TYLENOL). The adverse events did not require an emergency room/ physician office. She mentioned that she has read all literature, it says you can get side effects, but this isn't normal. The outcome of the events limb discomfort, pain and headache were recovering while the outcome of the other events was unknown.
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| 67 | 2021-02-26 | joint pain, musculoskeletal stiffness, neck pain |
Dose was injected at 9:30 am and around 1 pm, my neck started to stiffen up and get sore on both sid...
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Dose was injected at 9:30 am and around 1 pm, my neck started to stiffen up and get sore on both sides and up into occipital region. It was very painful and difficult to turn my head in either direction. It started to ease after 5 or 6 hours but my neck still feels somewhat sore now which is 3 days later. My injection site was throbbing and painful from elbow to shoulder from about 1 pm until about noon the next day. I did not experience any fever but felt tired.
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| 67 | 2021-02-26 | muscle pain | Chills, muscle aches, headache. Gone in 12 hours. No treatment other than rest. |
| 67 | 2021-02-27 | joint pain, muscle pain |
Started with Chills approx 8 pm same day as vaccine given. Developed general weakness/tiredness, fe...
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Started with Chills approx 8 pm same day as vaccine given. Developed general weakness/tiredness, fever, headache, muscle/joint pain, nausea, dizziness with made it difficult to walk to the bathroom d/t the dizziness, general unwell feeling. I took tylenol. I applied ice packs to my neck and core body area. I was confined to the bed until Friday apprx 11:00 am until I could get up. I continue to feel "funny" in the head at times. I did not seek any Dr or hospital visit.
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| 67 | 2021-02-27 | muscle tightness |
Tingling and numbness in fingers, hands and arms. Abdominal tightness. No special treatment done oth...
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Tingling and numbness in fingers, hands and arms. Abdominal tightness. No special treatment done other than waiting for symptoms to subside. Symptoms passed in approx. 1 hr.
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| 67 | 2021-02-28 | joint pain |
Multiple joints( wrists, elbows, shoulders, and hand fingers) excruciating pain, swelling with han...
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Multiple joints( wrists, elbows, shoulders, and hand fingers) excruciating pain, swelling with hand and shoulder movement limitation. Last two days chest discomfort with some difficulty in breathing. Last night first time developed severe skull pain at posterior area. Symptoms mainly during night time and unable to sleep due to the intensity. Treatment: Voltaren Gel 1%, Generic Mobic 7.5 mg and Sombra Warm Therapy Natural Pain Reliving Gel, Acetaminophen 500mg. Most of the symptoms have been for the last three weeks.
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| 67 | 2021-02-28 | muscle pain |
Achy right arm (site of injection) about 12 hours after injection; achy muscles all over body; This ...
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Achy right arm (site of injection) about 12 hours after injection; achy muscles all over body; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EM9809), via an unspecified route of administration on 13Feb2021 10:00 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant at the time of vaccination. The facility type vaccine was Pharmacy or Drug Store. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. None medical history. Concomitant medication included omeprazole, fexofenadine hydrochloride (ALLEGRA). The patient experienced achy right arm (site of injection) about 12 hours after injection on 13Feb2021 21:30; achy muscles all over body about 16 hours after injection on 13Feb2021. Pain was relieved by taking two naproxen tablets. The outcome of events was recovered in Feb2021. The events were reported as non-serious.
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| 67 | 2021-03-01 | joint pain, back pain | headache tiredness back and shoulder ache treated with ibuprofen |
| 67 | 2021-03-01 | joint pain, muscle pain |
Day 1: uncontrollable coughing spasms for several minutes, piercing joint pain in left shoulder cap...
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Day 1: uncontrollable coughing spasms for several minutes, piercing joint pain in left shoulder capsule and right ankle, 101 degree fever lasting 6 hours Day 2: chills, exhaustion/weakness, inability to concentrate, lack of appetite Day 3 &4: waves of muscle aches and exhaustion
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| 67 | 2021-03-02 | joint pain, neck pain |
Mild pain upper right arm/shoulder/neck immediately after receiving vaccination. Pain worse next day...
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Mild pain upper right arm/shoulder/neck immediately after receiving vaccination. Pain worse next day. Arm/shoulder pain resolved within a few days, neck pain persists - has not resolved. Also developed swollen lymph node right side of neck 1 day after vaccination which remains swollen. Saw FNP in regular provider office 2/04/21, no treatment recommended. Episode of benign positional vertigo 1/21/21. No history of this, FNP thought it could have been related to vaccination. Severe vertigo resolved after treatment, still have occasional mild vertigo episodes.
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| 67 | 2021-03-02 | joint pain |
Chills; Injection site pain; flu; cold; Joint pain; Muscle stagnant; Where they gave me the shot the...
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Chills; Injection site pain; flu; cold; Joint pain; Muscle stagnant; Where they gave me the shot the muscle goes jumping up and down; Not feeling well; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL9262 expiry date not reported, via an unspecified route of administration from 28Jan2021 at single dose for COVID-19 Immunization. Medical history included High blood pressure and Pre-diabetic. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) 12.5 mg, metformin (METFORMIN) 1000 mg, twice a day, lisinopril (LISINOPRIL) 20 mg at night, pravastatin (PRAVASTATIN) 20 mg, acetylsalicylic acid (BABY ASPIRIN) and atorvastatin calcium (ATROSTAT). The patient experienced joint pain, not feeling well and muscle stagnant; where they gave me the shot the muscle goes jumping up and down all on 29Jan2021 and chills, injection site pain, flu and cold all on unspecified date. Consumer stated, "I am having a joint pain and chills and not feeling well, I had it Thursday evening, I took it Thursday evening. I am not feeling well from that Friday night and last night I mean the joint pain, the muscle pain you know, it's just you have to deal with." Consumer added, "I have been taking pain medicines, Ibuprofen and Tramadol for pain and Mucinex for cold and flu." Therapeutic measures were taken as a result of joint pain, injection site pain, flu and cold. Outcome of the events was unknown.
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| 67 | 2021-03-02 | joint pain |
injection site pain; headache; joint pain; nausea; feeling unwell; tiredness/tired; swollen lymph no...
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injection site pain; headache; joint pain; nausea; feeling unwell; tiredness/tired; swollen lymph nodes under left arm; achy; This is a spontaneous report from a contactable consumer reporting for herself. This 67-year-old non-pregnant female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Jan2021 at 09:30 AM, in left arm, for COVID-19 immunisation. Medical history included allergies to sulfa and COVID before vaccination. Concomitant medications included calcium, glucosamine/chondroitin and unspecified multivitamin. On 30Jan2021 at 16:00 the patient experienced injection site pain, headache, joint pain, nausea, feeling unwell, tiredness, swollen lymph nodes under left arm and achy. The events got progressively worse the following day. On 01Feb2021 the patient was too tired and achy to go to work. The events did not require any treatment and were resolving at the time of report. COVID was not tested post vaccination. No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
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| 67 | 2021-03-02 | armpit pain, joint pain |
Vaccine 5:30 pm 2/27, sensitive skin 10:30 am 2/28 - 1:30 pm 3/1, sore joints in hands and feet 3/1...
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Vaccine 5:30 pm 2/27, sensitive skin 10:30 am 2/28 - 1:30 pm 3/1, sore joints in hands and feet 3/1 and 3/2, sore armpit 3/1 to current (3/3), pain decreasing, sore and pink patch at and below injection area 3/1 to current.
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| 67 | 2021-03-02 | muscle pain, joint pain |
Migraines 3 days, vomiting 1day, nausea 4 days. Muscle aches 4 days, joint pain 5 days. Exhaustion 5...
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Migraines 3 days, vomiting 1day, nausea 4 days. Muscle aches 4 days, joint pain 5 days. Exhaustion 5 days
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| 67 | 2021-03-03 | joint pain |
Severe pain in hands and knees where I have arthritis, tiredness low. Grade temp fluid retention doe...
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Severe pain in hands and knees where I have arthritis, tiredness low. Grade temp fluid retention doesn?t go down,
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| 67 | 2021-03-03 | back pain, neck pain |
When I received the injection I felt a sharp pain go up the side of my neck and along my upper back....
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When I received the injection I felt a sharp pain go up the side of my neck and along my upper back. When I awoke the next day, I could not turn my head to the left without pain.
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| 67 | 2021-03-03 | muscular weakness |
pt. describes dizziness and weakness in arms shortly after recieving 2nd dose vaccine. BP 177/88, O2...
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pt. describes dizziness and weakness in arms shortly after recieving 2nd dose vaccine. BP 177/88, O2 98, HR 81. Pt was monitored for 30 minutes, pt. drank water and orange juice. Pt. felt better 30 minutes later, BP improved 157/83, o2 96, HR 80. Pt went home with sister.
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| 67 | 2021-03-03 | muscle pain |
Yesterday I received my 2nd Pfizer vaccine at 9AM. My first dose was a non-event. About 50 minutes a...
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Yesterday I received my 2nd Pfizer vaccine at 9AM. My first dose was a non-event. About 50 minutes after the jab, I broke out in hives on my upper thigh and stomach. By 7 PM, I felt really sick, my arm felt as though the strongest person in the world punched me, and by 8, I was shivering and wrapped in a ton of blankets, by 10, every muscle in my body ached beyond its capacity and my fever was 101.8. It got to 102.1. My head was weighed down with an unrelenting headache. Finally, an hour ago, my fever broke. I have Systemic Lupus and CRPS and do not vaccinate because my body is always attacking itself. But this year I got my first ever flu vaccine. Same results. So sick.
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| 67 | 2021-03-04 | joint pain |
Severe headache, fever high at 101, aches in joints, nausea and vomiting,fatigue. Started at about 1...
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Severe headache, fever high at 101, aches in joints, nausea and vomiting,fatigue. Started at about 1 am on 3/5/21. Fever has dropped to 100 as of 4 pm. Severe headache persists. Advil every 6-7 hours, fluids regularly
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| 67 | 2021-03-04 | joint pain |
My shoulder became very sore, very quickly. After 3 weeks, I am still unable to lift my arm out to ...
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My shoulder became very sore, very quickly. After 3 weeks, I am still unable to lift my arm out to the side above my shoulder. I started treatment at my acupuncturist last week and it is helping some, but I still have limited use of my right arm.
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| 67 | 2021-03-04 | armpit pain |
Woke up feeling fine, a few hours later started with fatigue, extreme chills, achy, and my arm was v...
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Woke up feeling fine, a few hours later started with fatigue, extreme chills, achy, and my arm was very sore swollen some at injection site, however, I had swelling under my armpit that was very tender and sore to touch. These symptoms lasted for 2 days, the armpit tenderness lasted for 4 days. I could t keep my blood sugar levels low, as they remained high almost 400. I was taking additional insulin to try and bring it down and I wasn?t eating.
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| 67 | 2021-03-05 | joint pain | Right ankle and mid-lower tibia pain (sharp). Pain moved to toes. BP 141/76 (pulse 95). |
| 67 | 2021-03-06 | joint pain, bone pain | Bone and joint pain, fever. Joint pain severe. Headache. Lasted 48 hours. |
| 67 | 2021-03-06 | joint pain, muscle pain |
Severe muscle and joint pain Severe body aches Skin pain Severe headache Nausea Vomiting Fever S...
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Severe muscle and joint pain Severe body aches Skin pain Severe headache Nausea Vomiting Fever Severe chills Left arm pain Injection site swelling, redness hives around left upper arm Left axillary lymph node swelling
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| 67 | 2021-03-06 | joint pain |
Severe chills, joint aches, headache, fatigue. Took some Aleve which improved symptoms, but felt li...
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Severe chills, joint aches, headache, fatigue. Took some Aleve which improved symptoms, but felt like mild flu symptoms for about 12 hours. Felt better about 12 hours later, then felt completely normal by the next morning.
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| 67 | 2021-03-06 | joint pain |
My left ankle hurt when I got in bed the first night after the shot. My ankle had been sprained in 2...
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My left ankle hurt when I got in bed the first night after the shot. My ankle had been sprained in 2018. Pain was less the following day.
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| 67 | 2021-03-06 | neck pain |
An hour after vaccine, my arm got very sore, then neck pain and headache. Followed by fatigue and ch...
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An hour after vaccine, my arm got very sore, then neck pain and headache. Followed by fatigue and chills for about 6 hours. It was tolerable and manageable with Ibuprofen and lots of water.
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| 67 | 2021-03-07 | muscle pain, joint pain |
Chills; pain wasn't constant it was jumping to different parts of her body; difficulty in breathing/...
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Chills; pain wasn't constant it was jumping to different parts of her body; difficulty in breathing/labored breathing; tightness in the chest/chest felt tight there was a heaviness just like a feeling of discomfort; joint pain started in her right elbow, right thumb, right knee, left ankle and left instep; Feeling unwell; Muscle pain; Injection site pain; Headache; has not felt normal; Tiredness; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261), intramuscularly on 22Jan2021 09:35 at 0.3 ml single dose for COVID-19 immunization. Medical history included ongoing High cholesterol, allergies to penicillin and sulfanized antibiotics, allergies to latex, Shingles since 2007, post herpetic neuralgia, mild shingles pain from the neuralgia, changes in temperature, the temperature and the weather going up and down. No other condition was reported. Concomitant medication included rosuvastatin (strength: 10mg) from 18Jan2021 to 24Jan2021 at 10 mg for High cholesterol. Past drug event included doxycycline allergy (she had a reaction to that she was sweating profusely and had very rapid heartrate and elevated BP and unable to sleep), Ibuprofen allergy, Levaquin allergy, Valium allergy and omeprazole allergy, took sulfanized (SULFA) antibiotics allergy (she had rapid heartbeat, sweating). Patient stated she said that she had received the first dose of the COVID-19 vaccine and did experience some side effects of the COVID-19 vaccine. She said she did not have an anaphylactic reaction but had difficulty in breathing 2 days after having the first dose. She said she experienced 30 hours of labored breathing. She wanted to know if there is "sulfa dioxide" in the lipid/mRNA portion of the COVID-19 vaccine. She said she is highly allergic to "sulfanized compounds". She is also allergic to all forms of penicillins. Caller wanted to know if the second dose of the vaccine has the same ingredients as the first dose. She wanted to know if the ingredients have the same amounts as the first dose or if the actives are stronger. She based this question from "most people having more reaction on the second dose of the vaccine" and also from what Pfizer second line told her "the first dose primes the system while the second dose strengthens the system". She wanted to know what ingredient causes the anaphylactic reactions for this vaccine and if it is penicillin. On 22Jan2021 she learned that there is a small amount of Sulfa Dioxide in the lipid portion of mRNA and she is highly allergic to sulfa compounds. With her side effects she would also like to add that she had a severe case of shingles in 2007 that was not diagnosed until the end of the 7th week. She had seen 8 doctors, her family doctor, she had 3 ER visits so prior to the vaccine she had post herpetic neuralgia and so a week and half before the vaccine there were changes in temperature, the temperature and the weather going up and down so she was having mild shingles pain from the neuralgia going into the vaccine which was given on 22Jan2021. The other thing is she had high cholesterol and her cardiologist put her on a statin she does not have high BP but she has high cholesterol so she was started on a statin, it was Crestor 10 mg, actually it says it is Rosuvastatin Calcium 10 mg and she took that 18Jan2021 and the 19Jan2021 and then on the 20Jan2021 her doctor told her to stop it before her vaccine so she did and she felt okay just had mild reactions so she took the Rosuvastatin that Friday night 22Jan2021 and she took it 23Jan2021 then she took her self-off of it on 24Jan2021. She called her doctor on 25Jan2021 and he said yes stop the Rosuvastatin and stay off it until after your second dose of the vaccine. So she was having an allergic reaction in Jan2021 she has had a lot of side effects from being post shingles and all the side effects from COVID vaccine and being post shingles and the statin all of the possible side effects mirror one another. As far as the reaction she got a headache about 35 minutes after she took the shot Friday morning at about 9:35 AM and she took Tylenol twice that day, once that morning and she took it also around 4:30 PM when she was having medium pain at the injection site and that is when she took her statin and she woke up on 23Jan2021 and until late in the afternoon she had tightness in the chest so she took one more Tylenol then that was mid-morning, so total she had 3 doses of 325 mg Tylenol. Then on 24Jan2021 at about 4:30 AM in the morning she woke up with labored breathing, it wasn't normal. She did not have a closed throat but her breathing was labored, her chest felt tight there was a heaviness just like a feeling of discomfort. Then around 5 pm that same day the joint pain started in her right elbow, right thumb, right knee, left ankle and left instep and the pain wasn't constant it was jumping to different parts of her body and she still felt the tightness in her chest and heaviness all day. Then around 4PM on 24Jan2021, Saturday the labored breathing dissipated around 8pm and she did not take the statin that night then on 25Jan2021 her breathing was normal but she still had tightness in her chest. She had injection site pain on the 22Jan2021, 23Jan2021 and the 24Jan2021 and it was almost totally gone on 25Jan2021. Tiredness began on the evening 22Jan2021 the day she had the shot and it comes and goes. Headache- she had mild headache and she had took Tylenol so it was mitigated a little but it started 22Jan2021 and she had a headache through the 23Jan2021, 24Jan2021 and the 27Jan2021 so around 3:25PM yesterday she took another Tylenol yesterday 27Jan2021. Muscle pain she has had since 23Jan2021 and it has been ongoing but less today, she doesn't know if it will come back or not. It is mainly in the in the rhomboids which is the shoulder wings. She had it on both sides. Chills she had 25Jan2021, 26Jan2021 and 27Jan2021 and they come on mid-day-late afternoon they go on up until early evening, a little past supper/dinner time. Joint pain was 23Jan2021, 24Jan2021, 27Jan2021 and pain in her rhomboid muscles. She has had no fever, no swelling or redness at the injection site, no nausea. Feeling unwell- she would say from 23Jan2021 to the present she has not felt normal on 22Jan2021, it comes and goes She has not had swollen lymph nodes. Difficulty breathing 24Jan2021 at 4:30 am it woke her up and she had labored breathing, no closed throat and she stopped the Statin that day, tightness in her chest started 24Jan2021 in the morning and she had that 25Jan2021 26Jan2021 and it has been present on and off mainly in her back discomfort. She says the tightness is not really in the front around the heart but it is like a total tightness in the chest area. Muscle pain on the 27Jan2021 mainly in her back, the rhomboids. Fast heartbeat- She was sound sleep this morning at about 12:45AM and it woke her up her heartrate was 87, her BP was 135/81 (2021) and she did an ice pack for 16 minutes on her head and then she went back to sleep at 4:45 AM she woke up again her BP 131/87 pulse was 80 temp was 97.8 (2021). She didn't take her temp the first time she woke up she just did an ice pack for 16 minutes and she as up for a while typing side effects at that point. Then she went back to sleep from 6:20-7:20 and then when she woke up again her BP was 122/75 and pulse was 64, temp 98.3 (2021). For someone look at at her BP they may say that's not high but for someone post shingles, the pain, the nerve endings are already on edge she can feel it working on her body. They say reactions are proof that the vaccine is working but her issue with the joint pain, it disappeared when she stopped the Statin and then there is the labored breathing, she has had 2 new drugs that went into her system at the same time and she doesn't know, one has the documented side effects and the other one it is so unknown at least the mRNA part she does not know if she is just having a reaction to Sulfa. She says that blood pressure doesn't seem high but for someone whose body is stressed and with her pulse to go up when she is sound asleep, normally when her body is sleeping and she wakes up she would be about 117/70 (2021), she would have low numbers she doesn't have high BP. She took the statin for 2-3 days and then stopped it her doctor told her she could start and stop it and her doctor told her to stay off of it but she started it because she felt okay she only had a headache and injection pain so she said she is going to take it and then things intensified so she decided to stay off it. She has a history of having delayed serious side effects. She is allergic also to Penicillin and that is probably in the records already because she called and asked when she was thinking about taking it. It dates way back with her allergies with her, it is extensive Doxycycline, Ibuprofen, Levaquin, all forms of Penicillin, sulfanized antibiotics, Valium, latex, Omeprazole. She had shingles so bad after about 7.5 weeks of it going undiagnosed she had the 2 worse reaction and they asked her they went through her history and asked what are the 2 worst things she had and that was with Doxycycline they gave her that because they thought she had a bacterial infection and didn't realize it was shingles and she had a reaction to that she was sweating profusely and had very rapid heartrate and elevated BP she was unable to sleep literally she could feel the blood coursing through her veins. and then the other one she knows is Sulfa she has had that allergy since a child but she had rapid heart beat, sweating and there may have been other symptoms but she does not remember she was a child. She has been given Sulfa drugs since then and she is highly sensitive to Sulfa. Outcome of the event muscle pain was not recovered; injection site pain was recovered on 25Jan2021; labored breathing was recovered on 24Jan2021, while other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-03-07 | muscle pain |
The day after receiving the vaccine (Wednesday 3/3/21) I noticed extreme sensitivity to sunshine whi...
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The day after receiving the vaccine (Wednesday 3/3/21) I noticed extreme sensitivity to sunshine while driving, even while wearing shades. Remind me of when I get my pupils dilated by the ophthalmologist. Also muscle pain, chills, and fatigue. All these symptoms disappeared by the next day, but the fatigue remained through the weekend. Today, 3/8/21 I feel back to normal. I had Covid 19 in May 2020, so I recognize some of the symptoms, except for the light sensitivity, which scared me. I will consult with my ophthalmologist before my second dose scheduled for 3/23/21.
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| 67 | 2021-03-08 | joint pain, muscle pain |
Intense pain at injection site but no swelling or redness Intense body and joint pain and muscle cra...
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Intense pain at injection site but no swelling or redness Intense body and joint pain and muscle cramps. Difficulty walking. Fatigue. Chills and Fever 102.2 degrees. Brain fog and off-balance could not sleep but no headache. Nausea no appetite. Nasal congestion and mild cough. Symptoms woke me at 2 am with chills. Took 500 mg acetominophin at 10 am. Forgot to take medication resulted in high heart rate and blood glucose. Symptoms started to decrease after 2 pm 2/28/21. Took 500 mg acetominophin around 3 pm. Fever 100. 5 on 3/1. Fever 100 on 3.2 Felt better but cancelled morning appointment on 3/3. Went for short walk outside on 3/5/21. Did not seek medical care. Still have muscle pain fatigue and brain fog.
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| 67 | 2021-03-08 | muscle pain |
Rec'd 1rst shot @ noon Friday 2/26/21. By Monday afternoon my head started to ache & skin of extremi...
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Rec'd 1rst shot @ noon Friday 2/26/21. By Monday afternoon my head started to ache & skin of extremities started stinging, nose running & feeling feverish. My ears started ringing too & got vertigo. Also I started having trouble breathing with a slight ache/pain in my lungs. A noticible itch started in my nose & a tickle in my throat and I had extreme muscle pain, especially in extremities affected by previous carpal tunnel injuries & sciatica. Tuesday afternoon all symptoms were worsening so I used Zicam Gel swabs in my nose, made chicken garlic soup & tea with honey & went to bed. It took 3 days for the sinus, headache & respiratory symptoms to resolve. The neuropathy (skin stinging) pain in my arms, hands & lower legs persists and is very painful.
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| 67 | 2021-03-09 | joint pain, back pain |
After my second vaccination, the next morning I had generalized arthralgias. The second morning, I ...
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After my second vaccination, the next morning I had generalized arthralgias. The second morning, I woke up with severe, sharp pain in my lower back. Over the past many weeks, it has begun to improve as I am moving around during the day.
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| 67 | 2021-03-09 | bone pain |
bone ache; body shaking chills; no appetite; exhaustion; headache; occasional nausea; incapacitating...
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bone ache; body shaking chills; no appetite; exhaustion; headache; occasional nausea; incapacitating fever; This is a spontaneous report from a contactable consumer, the patient. This 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9265), dose 2 , single dose via an unspecified route of administration in the left arm on 02Feb2021 at 14:00 (at the age of 67 years-old) for COVID-19 vaccination. The patient was not pregnant. Medical history included primary immunodeficiency, diabetes, irritable bowel disease, gastroesophageal reflux disease (GERD), high cholesterol and allergy to cefazolin (ANCEF). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248, dose 1 on 12Jan2021 at 2:15 PM in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included famotidine, lansoprazole, pioglitazone and rosuvastatin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 03Feb2021 at 09:00 AM, the patient experienced bone ache, body shaking chills, no appetite, exhaustion, headache, occasional nausea and incapacitating fever. Treatment was not received for the events. The clinical outcome of bone ache, body shaking chills, no appetite, exhaustion, headache, occasional nausea and incapacitating fever was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 67 | 2021-03-09 | musculoskeletal stiffness |
This is a spontaneous report from a contactable Consumer(patient). This consumer reported similar ev...
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This is a spontaneous report from a contactable Consumer(patient). This consumer reported similar events for the patient. This is the first of two reports. A 67-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration at Arm Right on 14-JAN-2021 at the 67 years old at single dose for COVID-19 immunization. The medical history included breast cancer survivor, allergies to strawberries, bananas, lobster, mahi, whiting fish. The concomitant medications were cholecalciferol (VITAMIN D), ascorbic acid(VITAMIN C), collagen, curcuma longa(TURMERIC) , olive oil. The patient previously took VALIUM and experienced allergy. The patient got hives near her left eye with the first Pfizer shot in 2021 but wasn't sure if that was the cause as she did have food allergies. Her arm was a little stiff but not significantly and she did not have any other side effects in 2021. There was not treatment received for all the events. The patient had no Covid prior vaccination. There was no Covid tested post vaccination. The outcome of the events was recovered in 2021. The information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148988 same patient, same product( different dose), similar events
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| 67 | 2021-03-09 | muscle pain, joint pain |
Severe joint pain Along w muscle pain I have NEVER had joint pain before this! Symptoms started 03 /...
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Severe joint pain Along w muscle pain I have NEVER had joint pain before this! Symptoms started 03 / 08/21
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| 67 | 2021-03-11 | musculoskeletal stiffness |
Awoke on Day 2 post injection with extremely stiff neck on side vaccine was received. Neck stiffness...
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Awoke on Day 2 post injection with extremely stiff neck on side vaccine was received. Neck stiffness and pain with lateral movement slowly subsided over 3 -4days. No known sequelae.
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| 67 | 2021-03-13 | armpit pain |
Pain at injection site 12:44pm 4:25 pm high temperature of 102 took tylenol. Swelling and pain und...
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Pain at injection site 12:44pm 4:25 pm high temperature of 102 took tylenol. Swelling and pain under left armpit. Felt a lump in my left breast. Feels like someone punched me real hard in my armpit. Took Ibuprofen for swelling. Swelling and pain lasted 3-4 days then subsided and now there is no longer any pain. Don't feel the lump any longer in my left breast.
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| 67 | 2021-03-13 | muscle pain, joint pain |
ongoing symptoms of headache, muscle aches, fatigue, insomnia, elevated temperature( no fever above ...
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ongoing symptoms of headache, muscle aches, fatigue, insomnia, elevated temperature( no fever above 99 degrees) joint aches, swollen lymph nodes, sweats, scratchy throat, red irritated eyes, bowel cramps and nausea
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| 67 | 2021-03-14 | joint pain | Joints extremely sore, body aches, fatigu |
| 67 | 2021-03-14 | muscle pain | Nausea muscle aches chills very painful left arm |
| 67 | 2021-03-15 | armpit pain, musculoskeletal discomfort, muscle pain |
Sore arm for the rest of the day after receiving the shot. On 2/27 fatigue. On 3/4 possible low gr...
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Sore arm for the rest of the day after receiving the shot. On 2/27 fatigue. On 3/4 possible low grade temperature with periods of feeling very warm and sweating. Lasted approximately an hour. On 3/6 again periods of feeling warm and sweating. Rotating achiness in muscles. Brief feelings of discomfort in axillary region but unable to palpate lymph node. Lasted half the day. On 3/14 headache across the front of my face above my eyes with left side neck discomfort. On 3/15 again experienced periods of warmth and sweating throughout the day. In between headache, Not as severe as headache on 3/14. Contacted doctor by email.
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| 67 | 2021-03-15 | limb discomfort |
Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and i...
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Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and it felt heavy and it just dropped. She then started to raise the arm and she was not able to do it. She then suddenly lost sensation in her left arm. She then could not control it, would raise when it wanted to but was not able to feel it or control it. (had the feeling that it was not connected to her body and it was just floating around). Then started having involuntary muscle spasms in her mid torso region. The same thing then happened again and the muscle spasms were more intense and she waited around and lasted for minutes. She never lost consciousness, but then it happened again and was spreading on her left side. It then encompassed from her hip up to her shoulder. The involuntary muscle spasms were moving from the side toward her chest to where she felt it would impact her breathing. She then went to the ER and they started doing testing, and she had more spasms, and then started having double vision. In talking with the doctor about all of this she had a CVA with complex partial epilepsy with recurrent seizures and that the double vision was related to the infarct in her brain and that the stroke triggered the seizure that she had. She did not lose any memory, loss of consciousness, no weakness or loss of sensation. These episodes only lasted minutes and a refractory time of minutes and when she got to the ER she the other episode when they were trying to test her. They were not able to do the EKG or EEG due to the involuntary movements and these resolved. She is now completely recovered other than the fatigue with no residual. She saw a neurologist on 2/24/21 who felt like that she had a stroke and put her on Keppra and is going to FU in 3 months at IU. It was ruled out that there was no relationship of her transplant to this reaction. She is now on Keppra, Atorvastatin for the swelling in her brain, and also put on aspirin 81 mg. Her blood tests that were done were all drawn and were all within normal limits except for kidney function, but is only a minor #'s for her secondary to the transplant. She then had some titers drawn for CMV and that was also negative. Then she had a COVID test that was negative. Then she had spinal tap that came back normal results.
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| 67 | 2021-03-16 | back pain |
pt developed bad case of shingles on Left abdomen to left side of back. Went to Urgent care 3/12 an...
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pt developed bad case of shingles on Left abdomen to left side of back. Went to Urgent care 3/12 and was given acyclovir and cephalexin. pt is having stabbing pain on abdomen and back
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| 67 | 2021-03-16 | groin pain, back pain |
After 1st vaccine I started to have a little lower back, bilateral hip & groin pain.; After 1st vacc...
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After 1st vaccine I started to have a little lower back, bilateral hip & groin pain.; After 1st vaccine I started to have a little lower back, bilateral hip & groin pain.; pain increased as time went on; This is a spontaneous report from a contactable Nurse, the patient. This is the first of two reports and captures events experienced after the first vaccine. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9264,), via an unspecified route of administration on 28Jan2021 at 14:00 (at the age of 67-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history includes COPD and a history of failed lumbar fusions due to scoliosis. This was further reported as about three surgeries in the lumbar area for fusions due to scoliosis in the past years. The last one was about five years ago. Prior to the vaccination, the patient was not diagnosed with COVID-19. The vaccine was administered to the patient at a Health Clinic . Concomitant medications included roflumilast (DALIRESP), montelukast sodium (SINGULAIR), duloxetine (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN) and "SPIRI," all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took meperidine (DEMEROL) and experienced allergy. The patient reported that after the first vaccine, she started to have a little lower back, bilateral hip and groin pain on 30Jan2021. The pain increased as time went on (dates not specified). The patient mentioned having to use "narcotics, heat, ice, Tylenol or Ibuprofen" (dates not specified) to control pain. The clinical outcomes of the events low back pain, groin pain and pain aggravated were reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223014 same patient/drug, different vaccine dose/event
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| 67 | 2021-03-16 | musculoskeletal stiffness |
I believed I had received the full and appropriate dose of the Pfizer vaccine. Four days later the ...
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I believed I had received the full and appropriate dose of the Pfizer vaccine. Four days later the pharmacist contacted me telling me I had only received a saline solution and would need to get vaccinated again. I inquired how they knew this and received sparse information saying they couldn't tell me ... privacy etc. Then on March 10th I went to another one of their locations and received the first vaccine of Moderna ... I have been super sick since then.. I have had fever, delirium, cognitive impairment ( forget vocabulary MID sentence) severe covid arm, ( worse than the images on line) pain in my left hand, stiffness in my left fingers ( what I assume arthritis might be like) I WANT TO KNOW what WAS IN THE FIRST PFIZER INJECTION: I AM DEMANDING... to find out what was in the first shot, why it was reported to me 4 days later, How the facility knew it was only saline... WAS it TRULY ONLY SALINE or have I been injected with two different doses of vaccines within a 9 day period? I really need to know what it going on.
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| 67 | 2021-03-17 | joint pain |
3/14/21: 10:00 pm violent hand tremors - 3 hours 3/14/21: 10:30 pm nausea 3/14/21: 11:00 pm vomiti...
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3/14/21: 10:00 pm violent hand tremors - 3 hours 3/14/21: 10:30 pm nausea 3/14/21: 11:00 pm vomiting every hour - 7 hours and off and on the next 48 hours 3/15/21: 10:00 am extreme joint pain 48 hours 3/15/21: 10:00 am headache off and on 72 hours 3/16/21: 3:00 am 102.4 temperature (couple of hours?)16 3/16/21: 12:00 pm sore throat 24 hours 3/16/21: Fatigue Continues 3/16/21: Very dizzy 3/17/21: 3:00 pm injection side tenderness and slight swelling 48 hours 3/18/21: 3:00 pm first time able to get out of bead and shower - slight light headedness
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| 67 | 2021-03-17 | back pain, joint pain |
Sore arm at injection site, bad headache, chills, fever, aches in joints, back pain, nausea, tiredne...
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Sore arm at injection site, bad headache, chills, fever, aches in joints, back pain, nausea, tiredness Treatment, sumatriptan for headaches, Advil for aches , pain and fever. I was in bed for 2 1/2 days because I felt so sick and was very tired Most of my symptoms were better after 3 days but the headaches and tiredness are still bothering me today 3/18/21.
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| 67 | 2021-03-17 | muscle pain | Fever, headache, weakness, malaise, muscle aches |
| 67 | 2021-03-17 | neck pain, joint pain |
Initial minor pain at the injection site that became worse after the 3rd day. Pain radiating up the ...
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Initial minor pain at the injection site that became worse after the 3rd day. Pain radiating up the arm and shoulder into the neck area. Tingling in thumb and 3 fingers. Never have had any issues like this. Went to Orthopedic doctor who found arthritis in neck. Given Prednesone but did not help at all. Called doctor again and asked if tingling in hands was associated with arthritis and told not normally and what else I could do? Suggested an MRI which did not have yet. Pain is diminished today but tends to flare up. Pain is worse at night. Never had any symptoms like these before the 2nd Covid shot.
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| 67 | 2021-03-18 | joint pain, joint swelling |
Rash; Joints and fingers swelling/hands were swollen; Joints and fingers swelling; wrist was sore; F...
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Rash; Joints and fingers swelling/hands were swollen; Joints and fingers swelling; wrist was sore; Freezing and chills; Felt like would pass out/felt so faint; Ate dinner but food came back up; Shortness of breath; Cheeks flushed; Achy; felt draggy/feeling tired; This is a spontaneous report from a contactable. A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCIN) lot number: GL9266, via an unspecified route of administration, administered in left arm on 21Feb2021 as single dose for COVID-19 immunisation. Medical history included rheumatic fever (occurred age 7), vulvovaginal dryness and sore joints. The patient was negative on Covid test on an unspecified date. Historical vaccine included BNT162B2 on 28Jan2021 for COVID-19 immunisation and flu shot. Concomitant medications included estradiol (IMVEXXY) taken for vulvovaginal dryness; vitamin C [ascorbic acid] (VITAMIN C); colecalciferol (VITAMIN D); calcium. On Monday, 22Feb2021, the patient felt draggy, but did not think it was a big deal. She just thought it was from the shot and was feeling tired. The draggy feeling lasted a few days, but she was unable to clarify outcome further. On Tuesday, she started to feel achy and felt like that too was to be expected. The achiness went away on 25Feb2021. On Wednesday, 24Feb2021, she was really busy. She was still achy but was busy. She also did not drink much water for several hours. It dawned on her later when she was not feeling good. Late Wednesday afternoon it was like everything cratered and she felt horrible. She was feeling bad. She was freezing and had chills. It was a horrible feeling. She helps with her grandkids since she is retired. They were home from school and had to sit on the couch. She felt cold, yucky, and achy. It was a yucky feeling. She went home a couple of hours later. She told her husband she had to lie down on the couch because she felt horrible. She could not further describe horrible feeling. Her daughter had called her as well and was unable to describe how she felt to her daughter. She could only say she felt so sick but could not explain further. She felt awful and could not put her finger on it. She was laying down and when she got up, she felt like she would pass out. At that time, she had not eaten dinner yet. She ate dinner, took one bite and the food came back up. For a few moments she felt so faint, she felt shortness of breath, but it was only for a few seconds. After that, her and her and her husband took a drive to go to hospital. However, by the time she got to hospital she was feeling better. She was also talking to a friend at that time who said all of this was probably form the shot as well. Since she was feeling better decided not to go into the hospital and went back home. At the time she was thinking this was all from the shot and no big deal. On Wednesday night, things got crazy and worse. That evening Wednesday she was getting ready for bed and noticed her cheeks were flushed. On Thursday she got up and noticed rash. She was covered all over her body. It did not itchy really, but it was a rash. Not a bumpy rash, it reminds her of Roseola. Her joints and fingers were starting to swell. Her hands were swollen. It started with her knuckles, it went to her fingers, up to her hands, wrist. Her wrist was sore. Her joint swelling was worse. On Friday, she tried to see her doctor, but could not be seen by the doctor. However, she got in with the PA. When she saw the doctor, it could be seen her hands were swollen. However, the main reason she went to the doctor was due to the rash. However, her joints were sore and swollen. Treatment for rash included Hydroxyzine, for joints and fingers swollen/ wrist was soreincluded prednisone 10mg one tablet every day for five days. The patient recovered from the event felt like would pass out/felt so faint and shortness of breath on 24Feb2021. The outcome of the events joints and fingers swelling/hands were swollen, wrist was sore and cheeks flushed was not recovered.
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| 67 | 2021-03-18 | joint pain |
first event was 03/18/2021 11:30am: swelling of left supraclavicular lymph node took 325mg aspirin...
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first event was 03/18/2021 11:30am: swelling of left supraclavicular lymph node took 325mg aspirin. swelling has continued through this report following events 03/19/2021 10:30am: swelling of lymph node(s) in left armpit, pain in front of left shoulder joint, and joint aches in hips, legs, low back, hands took 400mg ibuprofen. aches diminished.
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| 67 | 2021-03-18 | joint pain |
9pm pressure at site; 1am pain in right arm at injection site; 3/19 7am pain in right scapula radia...
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9pm pressure at site; 1am pain in right arm at injection site; 3/19 7am pain in right scapula radiating up into neck; swelling to right side of neck; pain radiating down to hand with pain in first two knuckles; swelling noted to axillary area; pressure moving to 1st and second rib from shoulder; feeling of fullness in right arm and shoulder; difficulty move arm and hand grasp affected.
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| 67 | 2021-03-18 | joint pain |
Severe shoulder pain, for 8 hours, lessened with Advil. Still sore and limited movement 2 1/2 weeks ...
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Severe shoulder pain, for 8 hours, lessened with Advil. Still sore and limited movement 2 1/2 weeks later. Also, strange auditory effect in right ear. Sounds heard almost like an echo, especially when I talked. Lasted about 5 days.
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| 67 | 2021-03-19 | joint pain, muscle pain |
I had somewhat similar results the 1st does. Same symptoms w/o fever 1st does. Chills, headache mu...
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I had somewhat similar results the 1st does. Same symptoms w/o fever 1st does. Chills, headache muscle aches joint pain fatigued. 2nd does, all the symptoms listed. I took tums and Advil which helped. This time had fever which lasted 24hrs. Stomach pains the time along with the other symptoms. Not unlike the actual virus I had!
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| 67 | 2021-03-20 | joint pain |
-About 20-25 minutes after received vaccine, had already left the facility felt a surge tightness wr...
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-About 20-25 minutes after received vaccine, had already left the facility felt a surge tightness wrap around my diaphragm up to my collar bone, as if my breath was being taken away. I yelped out but the three people in the car with me did not here me. I remained calm took a deep breath- feeling went away. - Had vaccine on Saturday. Woke up in the night on Sunday night, feeling like my tongue was swelling and my throat was closing up. I took 1/2 Benadryl and used Albuterol enhaler. Temp was 99.8 (my average at home is 96.5)Fell back asleep. Woke up the next day and was fine. - other symptoms were tiredness, headaches, achy joints, which went away fairly as quickly. -since the vaccine I have had a bad outbreak of do
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| 67 | 2021-03-20 | muscle pain, joint pain |
Fever 103°, chills, muscle aches, joint pain, headache, difficult breathing, weakness, ringing in e...
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Fever 103°, chills, muscle aches, joint pain, headache, difficult breathing, weakness, ringing in ears
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| 67 | 2021-03-20 | muscle pain |
Pain in left arm, fatigue, headache, muscle aches starting at about 4 hours after the vaccine was ad...
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Pain in left arm, fatigue, headache, muscle aches starting at about 4 hours after the vaccine was administered and lasting for about 36 hours. Chills and mild fever starting about 12 hours after the vaccine was administered and lasting about 8 hours.
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| 67 | 2021-03-21 | joint pain, back pain |
1. Very tired, fatique, no energy which has never subsided. I sleep alot. 2. Headache sporadically...
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1. Very tired, fatique, no energy which has never subsided. I sleep alot. 2. Headache sporadically, now daily. 3. Back pain near kidney developed a week after vaccine. 4. Thirsty and for 3 days unquenchable thirst. 5. Had spurts of joint pain all over for several days. Did not have these symptoms with 1st vaccine, this has been progressing for 2 weeks, as of tomorrow, and got worse as time passed. I am very active and healthy and this has certainly impacted my routine. I still work. Visit to Dr. about back pain resulted in negative test and Dr. blamed it on vaccine.
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| 67 | 2021-03-21 | armpit pain |
About 9 1/2 hours after receiving the vaccine I began to experience flu-like symptoms : Full body ac...
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About 9 1/2 hours after receiving the vaccine I began to experience flu-like symptoms : Full body aches, chills and a headache. Also my armpits felt swollen and hurt a great deal. The symptoms lasted about 30 hours. By 7 am on the second day after the shot I felt fine however, both of my armpits are still hurting. I am assuming it is from swollen lymph nodes. (After the first shot I went for my annual mammogram and one lymph node in my left arm was still swollen.)
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| 67 | 2021-03-21 | neck pain |
Patient has pain that started after vaccine and is now ongoing. It is in the vaccinated arm and also...
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Patient has pain that started after vaccine and is now ongoing. It is in the vaccinated arm and also base of left neck. Describes pain as a burning nerve type pain. It is improving with time but not with gabapentin or tylenol. Hx of CRPS
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| 67 | 2021-03-21 | neck pain |
Woke up in middle of night with pain at the collar bone (same side as injection ) It was swollen and...
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Woke up in middle of night with pain at the collar bone (same side as injection ) It was swollen and felt a lump the size of a large marble . Went to the emergency room that morning. Seen by nurse practitioner and diagnosed with Inflammation of the lymph nodes. Could not confirm it was related to the vaccine. The next morning on 03/13 woke up with large very red patchy rash that covered the shoulder area and down to the elbow. Again same side as the injection. Took Benadryl for 5 days
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| 67 | 2021-03-22 | joint pain, muscle pain | Chills, low fever, achey muscles, achey joints, fatigue, headache, |
| 67 | 2021-03-22 | joint pain |
Temperature read 99 degrees upon arising. Elevated through out the day to a high of 100.2 at 9pm. Le...
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Temperature read 99 degrees upon arising. Elevated through out the day to a high of 100.2 at 9pm. Left armpit swollen & itchy. Dull headache all day. All joints in entire body ached entire day. Tired feeling all day and night. Slept 4-6:30 pm and 9:30 pm to 1:30 am the following morning. Temperature down to 99.2 degrees at 1:30 am. Difficulty raising left arm more than 45 degrees.
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| 67 | 2021-03-22 | muscle pain |
I am writing this on behalf of my mother. She received the first round of the vaccine (Pfizer/EL9269...
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I am writing this on behalf of my mother. She received the first round of the vaccine (Pfizer/EL9269) on 2/18/21. That evening she reported not feeling "right". Over the next two days after receiving the vaccine on Thursday she reported to family that she didnt feel well. She had no fever but muscle aches, an earache and sore throat (this was on Friday and Saturday). On Sunday her breathing became a bit labored. She still had previous symptoms reported and labored breathing -- she stated she thought she would have to go to the Dr the next day (Monday, Feb 22, 201) if she did not feel better. Sometime in the night of Feb 21st and Feb 22nd my mom passed away. My mom had many health problems. Heart disease, diabetic, she was on dialysis and had sleep apnea. However, she definitely seemed to be having some difficulty with the affects of the first vaccine. Please let her life be counted.
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| 67 | 2021-03-23 | joint pain |
Bilateral Knee Pain, crippling. Sudden onset. Pain walking and lying in bed. Today, 7 days later ...
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Bilateral Knee Pain, crippling. Sudden onset. Pain walking and lying in bed. Today, 7 days later still have pain, but manageable. Ice, elevation, Arnica and Advil helped to relieve pain.
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| 67 | 2021-03-24 | joint pain, muscle pain |
Severe chills, migraine, some nausea, zero appetite, body muscle pain and joint ache, soreness at va...
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Severe chills, migraine, some nausea, zero appetite, body muscle pain and joint ache, soreness at vax site and extreme tiredness. Symptom onset was 12 hours after the shot.
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| 67 | 2021-03-24 | joint pain |
No symptoms first dose 2nd dose: 18 hours- headache 24 hours-joints ache, sore arm 52 hours- diarrh...
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No symptoms first dose 2nd dose: 18 hours- headache 24 hours-joints ache, sore arm 52 hours- diarrhea, sore arm 74 hours- diarrhea
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| 67 | 2021-03-24 | neck pain, joint pain |
1st shot could lift arm all day and very dizzy felt sick for 3 days only, 2nd shot I went home and t...
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1st shot could lift arm all day and very dizzy felt sick for 3 days only, 2nd shot I went home and took a IB 800 like the guy told me because I told him about my reactions with the first one, I had no problems until the 4th or 5th day after the shot now I have continuing Joint aches,. pains in legs wrists. neck. its like my fibromyligia has came back in full force. I feel like crap! Headaches and hurt all over in my joints back just like I used to 20 years ago, I is very crappy!!
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| 67 | 2021-03-25 | joint pain, bone pain, neck pain |
Within an hour of the shot I felt very tired and took a long nap. Around 5 pm I began to feel a lit...
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Within an hour of the shot I felt very tired and took a long nap. Around 5 pm I began to feel a little achy and a slight headache. During the night, I ached all over, had a terrible headache, the muscles in my neck felt like they were drawing up, I had fever, but didn't get up to check it, my joints and bones ached, I had chills and it was a miserable night. The next morning I got up to make my breakfast and I kept trying to pass out and would have to sit down. I was sweating real bad and finally went to lay down. My husband fixed my lunch and I began to feel like my eyes were getting black, and then I slumped over and he said my head was bobbing on his shoulder. I could hear him saying my name, but I couldn't respond. Right after I cam to, I began to throw up at the table. He called an ambulance and they came and check me out. My blood pressure, blood sugar, EKG, and pulse ox were all normal. I refused going to the hospital, but I didn't know what the hospital could do for me. I called my family physician's office, but never heard back from them. I hear the second shot is worse than the first, so I am not sure if I should take the second shot. Also, strangely enough, my arm wasn't sore. Every time I have the flu shot I feel bad for a couple of days. I also felt bad after my Shringrix shot and pneumonia shots.
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| 67 | 2021-03-25 | joint pain |
fatigue, headache 6 hrs after vaccine (same as 1st dose), ~11 pm, severe chills, nausea, joint pai...
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fatigue, headache 6 hrs after vaccine (same as 1st dose), ~11 pm, severe chills, nausea, joint pain, short of breath ~ 2 am increased heart rate (112, usually in 80's) fever over next 3 days fever, joint pain, injection site redness and area on arm below -day - continued redness in arm
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| 67 | 2021-03-25 | joint pain |
A few hours after the shot, I experienced a mild bout of diarrhea. Then began to run a fever. The...
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A few hours after the shot, I experienced a mild bout of diarrhea. Then began to run a fever. The injection site and right arm became extremely heavy and painful. Overnight, I experienced fever, extreme muscle cramping and a burning sensation in all of my joints. Took a Tylenol at midnight which helped. Fever remained at 99.8 which is high for me. This lasted for the next 24 hours. Today, Friday the 26th, I am finally feeling better and fever is gone.
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| 67 | 2021-03-25 | muscle pain, joint pain | Chills Headache Muscle and Joint pain Trouble sleeping |
| 67 | 2021-03-25 | muscle pain, bone pain |
Couldn't get warm- very cold, her skin was very cold; Nausea; Pretty severe headache; Generalized ac...
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Couldn't get warm- very cold, her skin was very cold; Nausea; Pretty severe headache; Generalized aching; Fibromyalgia flare up; No energy been very tired; No energy been very tired; Felt like she was going to faint; Dizziness; Vision blurred; Loss of appetite; Flu-like symptoms; Hands feel warm to touch, but she still feels cold; She cannot sit or stand without discomfort in her spine; She cannot sit or stand without discomfort in her spine; Sick; Her bones and muscles hurt; Her bones and muscles hurt; Wheezing; This is a spontaneous report from a contactable Other HCP, the patient. A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE,Lot Number: EM9809; Expiration Date: 30Jun2021), intramuscularly, on 01Mar2021 at 13:45 (at the age of 67 years old) as a single dose in the left deltoid for COVID-19 immunization. Medical history included having become disabled in 2009, arrhythmia from 2014 and ongoing which was diagnosed after she took a Hep C treatment (Sovaldi, Ribavirin, Olysio). She had to take these medications for five months, where most people have to take it for three, ongoing allergic asthma - allergic to "everything." She has had this her whole life, diagnosed when she was 5. Started treatment with steroids at 16 , Hepatitis C from 1996 to 2014 diagnosed 4 years after blood transfusions Could have already gotten it as a nurse, was much more resistant than the average person 5 weeks to go negative, ongoing hepatic failure from 2013- she went into liver failure from Hep C. An event occurred- exposure of a deadly toxin that came from China, ongoing fibromyalgia from 1992 -Immediately after blood transfusions when her son was born- Gave her the correct blood but her body reacted. Flu shot in Early Oct2020 Fibromyalgia flare up, 4 times the dose (as reported)- Onset Age 66, Seizure disorder which was diagnosed in 2016 after disseminated shingles; after 2.5 months started having black outs where she did things and said things no memory of, the only way she knew it happened is if there were consequences. Doesn't know if she still has those, but she is getting an MRI and EEG. She lost vision in her right eye 2 years ago due to retina surgery macular pucker. She thinks her liver was stealing Vitamin A from her eye. Medical history also includes she ran over herself with her car, blood pressure abnormal, hepatic encephalopathy, autoimmune thyroiditis, and anxiety all from unknown dates and unknown if ongoing. The patient has had cataracts since an unknown date prior to the vaccination. The patient was diagnosed with "Rocky Mountain" in 2009. She also mentioned that when she got the vaccine she did not tell them that she was on steroids and an antibiotic. She commented that she was not in good shape when she took the vaccine to begin with. She is immunosuppressed and thinks that she should not have received the vaccination. But she also stated that she took the vaccine because she is a severe asthmatic and does not have a strong immune system so if she got COVID, she would die. Concomitant medication included benazepril (BENAZEPRIL) for blood pressure abnormal from an unspecified start date and ongoing; amlodipine (AMLODIPINE) for arrhythmia from 2014 and ongoing; rifaximin (XIFAXAN) for hepatic encephalopathy from 2014 and ongoing; lactulose (LACTULOSE)for hepatic failure, ammonia abnormal from 2014 and ongoing; levothyroxine sodium (SYNTHROID) for autoimmune thyroiditis from 1984 and ongoing; omeprazole (PRILOSEC [OMEPRAZOLE]) for reflux gastritis, chronic gastritis from an unspecified start date and ongoing; alprazolam (XANAX) for anxiety, post-traumatic stress disorder from 2009 and ongoing; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) for asthma from an unspecified start date and ongoing; ranitidine (RANITIDINE) for an unspecified indication, start and stop date were not reported.The patient previously took flu vaccine vii, olysio for hepatitis c and experienced histamine level increased, lyrica and experienced weight increased. Ten minutes after the vaccine was administered the patient experienced generalized aching on 01Mar2021 at 13:55 with outcome of not recovered. After twenty minutes she developed a pretty severe headache on 01Mar2021 14:05 with outcome of recovering. After 30 minutes she stared to feel nausea on 01Mar2021 at 14:15 with outcome of recovered. She stated that when she stood up to leave felt like started to feel dizzy on 01Mar2021 with outcome of unknown, and felt like she was going to faint on 01Mar2021 with outcome of unknown, her vision blurred on 01Mar2021 with outcome of not recovered and she had trouble getting into the elevator. She also experienced a loss of appetite on 01Mar2021 with outcome of recovering. The patient continued to describe her experiences noting that "things changed daily" and mentioning that she experienced fibromyalgia flare up on 01Mar2021 with outcome of not recovered, no energy been very tired on 01Mar2021 with outcome of not recovered , no energy been very tired on 01Mar2021 with outcome of not recovered , couldn't get warm- very cold, her skin was very cold on 02Mar2021 01:30 with outcome of not recovered, flu-like symptoms on 01Mar2021 with outcome of recovering, hands feel warm to touch, but she still feels cold on 01Mar2021 with outcome of unknown, she cannot sit or stand without discomfort in her spine on 01Mar2021 with outcome of unknown, she cannot sit or stand without discomfort in her spine on 01Mar2021 with outcome of unknown, sick in Mar2021 with outcome of unknown, her bones hurt in Mar2021 with outcome of unknown, her muscles hurt in Mar2021 with outcome of unknown, wheezing on an unspecified date in Mar2021 with outcome of unknown. Lab tests and procedures included cardiac output: over 50 percent, echocardiogram: her heart was good and clear, electroencephalogram with unknown results, magnetic resonance imaging with unknown results, all on unknown dates. Therapeutic measures were taken as a result of pretty severe headache; Sender's Comments: Based on the available information, the company considers that a causal relationship between generalized aching, severe headache, feel dizzy, going to faint, vision blurred, no energy been very tired, very cold, her skin was very cold, wheezing and bnt162b2 vaccine cannot be excluded due to plausible temporal association. The Company considers the reported event fibromyalgia flare up is unrelated to bnt162b2 vaccine but more likely due to underlying medical history of ongoing fibromyalgia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 67 | 2021-03-25 | muscle pain |
10 pm of 3/23 I started feeling headache and muscle pain. By 4:30 3/24 I was in great pain across m...
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10 pm of 3/23 I started feeling headache and muscle pain. By 4:30 3/24 I was in great pain across multiple locations across my body. I also had a heaviness in my chest, making it uncomfortable to breath.
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| 67 | 2021-03-26 | joint pain |
Muscle pain (all body muscles). Joint pain (including jaw & fingers) Headache (persistent - especia...
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Muscle pain (all body muscles). Joint pain (including jaw & fingers) Headache (persistent - especially forehead after tylenol or ibuprofen) Tiredness Feeling very unwell Treatment: Tylenol (650 mg, 2 tabs tid); and Ibuprofen (200 mg, 2 tabs qid) Outcome: All events, except headache & tiredness resolved following 9 days of treatment (3/25/2021). Headache & Tiredness finally get to bearable level on Day 11 (today; 3/27/2021).
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| 67 | 2021-03-27 | muscle pain |
3 phases- within 24 hrs of shot - low grade fever and chills lasting 24 hours; during the following ...
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3 phases- within 24 hrs of shot - low grade fever and chills lasting 24 hours; during the following 2 weeks, strong pain in arm muscle that travelling under arm into lymph nodes. Approximately 30 days after injection experienced a mild heart attack and unexplained pericarditis. Symptoms at onset were major pressure in chest and elevated blood pressure 210/99. Prescribed blood pressure medication, blood thinners and 4 does of indomethacin for pericarditis
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| 67 | 2021-03-28 | joint pain |
Right shoulder blade started hurting immediately, told administer. Later felt weak, clammy, nauseat...
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Right shoulder blade started hurting immediately, told administer. Later felt weak, clammy, nauseated, all over dizzy/shaky. Napped fitfully, sweat profusely (sour smelling sweat), weird dreams. After about 4 hours, woke, feeling better, but had not appetite to eat dinner. Started feeling all of the same again around 10 pm, so went to bed. Went through the same most of the night , woke around 7 am , feeling better, but seriously drained. Right shoulder blade still hurts. Still pretty drained, two days later.
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| 67 | 2021-03-29 | joint pain, muscle pain |
Extreme nausea; My symptoms were so severe I felt like I was going to die; I mean literally die; I t...
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Extreme nausea; My symptoms were so severe I felt like I was going to die; I mean literally die; I thought I am going to have a stroke; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; Chills; Headache; The chest pain was horrible; The joint and muscle pain were so severe; I am still little real nauseous; I feel like I mean like acid coming up constantly making me more nauseous; Unable to eat; The joint and muscle pain were so severe; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Left on 19Mar2021 (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient previously had first dose of BNT162B2 for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication includes supplements and multivitamins. The patient stated "I wanted to ask you and I have some horrible concerns I got my second COVID shot last Friday, and by Saturday night, I am not exaggerating, my symptoms were so severe I felt like I was going to die I mean literally die on 20Mar2021. I couldn't get to emergency room, I figured out I am just going to die, I just laid down and let my door open down so somebody could find me, the symptoms I was having was extreme nausea, chills, headache, the chest pain was horrible, horrible, the headache I mean I thought I am going to have a stroke, the joint and muscle pain were so severe. So I have been taking Tylenol, Advil (Treatment) finally this morning, yesterday was tiny, tiny bit better, this morning its little bit better but I am still little real nauseous and I feel like I mean like acid coming up constantly making me more nauseous and almost like unable to eat. Ever since Saturday all I will have been doing is three bites of chicken soup three times a day. What in the world is going on with this vaccine that it would cause those severe symptoms and my chest is still tight I still feel low congestion having hard time taking a deep breath in Mar2021". The outcome of the event "my symptoms were so severe I felt like I was going to die I mean literally die" was recovered on unspecified date. The outcome of the event unable to eat was unknown. The outcome of the rest of the events was recovering. Information on lot/ batch number has been requested.
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| 67 | 2021-03-29 | joint pain | joint ache post first dose low grade fever & joint ache post second dose |
| 67 | 2021-03-29 | back pain | Back ache, itchy rash |
| 67 | 2021-03-29 | joint swelling, joint pain | Burning sensation both thighs ..sciatica...knee pain swelling |
| 67 | 2021-03-29 | muscle pain |
Initially--fatigue, fever, muscle aches. On day 4--parethesia and numbness causing imbalance on le...
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Initially--fatigue, fever, muscle aches. On day 4--parethesia and numbness causing imbalance on left side. lasted a brief time--less than 20 minute. Day 5 paresthesia and numbness on waking up on left side, increased in intensity during the day. Difficulty walking and using left side. Muscle control lacking and balance very poor. The intensity of this fluctuates--there are days that improvement seems to be happening and then very bad days. Admitted to the hospital on Wednesday, March 24, 2021, via the ER. MRI, CAT scan, heart monitor, --these did not show evidence of a stroke as suspected at the time. The neurological symptoms persist, at times including numbing on the left side of my face.
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| 67 | 2021-03-29 | muscle pain |
No symptoms or site inflammation for 48 plus hrs Five days after, head congestion began. Eight days...
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No symptoms or site inflammation for 48 plus hrs Five days after, head congestion began. Eight days after I had full blown upper respiratory symptoms that lasted 36 hrs. Heavy prolonged cough with foamy white mucous, chills, headache, muscle aches , fatigue, dry scratchy throat. Symptoms are starting to ease, but cough mucous now turning yellow. I had a delayed reaction to the first pneumonia vaccine in 2018. Systems began 5 days after administering and became systemic and prolonged. I was wondering if this is also a delayed reaction. I had been self quarantined recently after visiting with family.
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| 67 | 2021-03-30 | joint pain, muscle pain |
also had a headache; her eyes have been really sore, red and she has several broken blood vessels in...
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also had a headache; her eyes have been really sore, red and she has several broken blood vessels in her eyes; her platelet levels dropped; having muscle pain or some kind of pain, maybe joint pain that is in her hips; has had nausea and she has generally felt unwell; muscle pain; she slept for almost two days; felt unwell; diarrhea; abdominal pain; her eyes have been really sore, red and she has several broken blood vessels in her eyes; her eyes have been really sore, red and she has several broken blood vessels in her eyes; tiredness; eyes were yellow when she woke up that morning; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6200), first dose via an unspecified route of administration, administered in Arm Left on 09Mar2021 11:45, single dose as SINGLE DOSE for covid-19 immunisation. Medical history included lung transplant from May2011, immunodeficiency from May2011 and ongoing, strokes. The patient had dtap vaccine before Jan2021. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN); prednisone acetate (PREDNISONE); tacrolimus monohydrate (TACROLIMUS). Patient reported that it has been about a week and a half of maybe more since her first COVID vaccine and she gets new symptoms almost everyday. Most of the symptoms aren't like put-you-down sick, horrible symptoms, they can be dealt with, but she has had a lot of them. She never got injection site pain and her arm never got sore. She had tiredness on the second day after her COVID vaccine, she slept for almost two days. She has a headache almost constantly. She is having muscle pain or some kind of pain, maybe joint pain that is in her hips. She doesn't have chills, a fever, injection site swelling or redness. She has had nausea and she has generally felt unwell all the time for a week and a half now. She is immunocompromised because she has had a lung transplant, that is the one thing that probably sets her apart is that she is immunosuppressed. She had the lung transplant almost 10 years ago now and she has been doing well. She is not on blood thinner medicine but she does take a baby aspirin everyday. Those are the only two things that she can think about. She doesn't know if all of that would make the symptoms from the COVID vaccine different for her. Most people she knows who have received the COVID vaccine have only had a couple days of tiredness and a sore arm. But she has a headache, been achy, and she just doesn't feel good. She also had a headache then and slept a lot, she was really tired. Later in the report caller clarified the first dose was actually 09Mar2021. She is not tired right now but she does still have a headache today, it is a pretty good headache. Her tiredness was Sunday and Monday of this week, confirmed to be 14Mar2021 and 15Mar2021. She says that she has recovered completely from the tiredness even though she feels like she could nap right now but she can't since she has a blood draw later. It is like she wakes up and every day she gets new symptoms. She had two symptoms that are not on the sheet of symptoms. The two she experienced are weird. On Saturday, a week and a day after her vaccine, her eyes were yellow when she woke up that morning. Confirmed date to be 13Mar2021. It was only that one day. She thinks that she has recovered completely. Also, her eyes have been really sore, red and she has several broken blood vessels in her eyes. Some of this is normal in the winter for her, but the yellow isn't normal for her. Normally, when she does get the blood vessels in her eyes they will heal in a day or so but the ones now have lasted much longer. They have been much slower to go away. It is not like there is a red spot, but it looks kind of red and kind of weird. The other symptom that is strange is that her platelet levels dropped. She was at 49 before her COVID vaccine and now her platelet level is down to 29. She does have normally very low levels for platelets but they are usually around 50. They have dropped substantially since her COVID vaccine. They dropped from 50 to 33 and then 5 days later her level went to 29. She is getting another platelet level drawn today, confirmed to be 16Mar2021. Her eyes being sore, red, and having broken blood vessels occurred probably a couple of days after she received the COVID vaccine. Specifically, her left eye felt like it had something in but she doesn't believe that it did. She used eye drops. Her eye just felt gritty. This is not like she had pink eye and she didn't wake up with this eye shut. It wasn't pink eye she knows what that is like. Her eyes had broken blood vessels and then they turned yellow then they turned red and have remained red. They are not sore today and she doesn't feel like she has gravel in her eye but the whites of her eyes don't really look clear. She says so far it has improved some but she will see since she wakes up every day and something new has happened, or something different or something has come back again. The good news is that she doesn't have all of these symptoms at the same time. She can't the remember the day pain in hips began but it is ongoing. She noticed this morning that the pain in her hip was not as bad when she had gotten out of bed. That pain has lessened there but the pain went to her head. Nausea and generally not feeling well: Probed for when this began and caller says that it has occurred for several days after she eats dinner, her stomach will be growling loud and that comes along with abdominal pain which doesn't really fit in with muscle or joint pain, she has no muscle there unfortunately she jokingly says. Sometimes this is all accompanied with diarrhea. It is not ongoing as of now, no date provided. She noticed that it comes and goes and sometimes she can eat and she is fine and sometimes she gets really sick feeling. It seems like if she doesn't eat then she doesn't get the symptoms but she knows that she needs to eat. Investigations: Her doctor has been having her do platelet blood tests about every 5 days since she took the COVID vaccine. She does not remember the dates of these tests off of the top of her head. She had a blood draw at the clinic the day before her COVID vaccine and her platelet count was 49 on 08Mar2021. For the result of 29 that was either last Thursday or last Friday, 11Mar2021 or 12Mar2021. Te outcome of the event scleral discoloration was recovered on 13Mar2021, tiredness was recovered on 15Mar2021, headache was not recovered, pain in hip was recovering, other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021299104 similar report from same reporter
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| 67 | 2021-03-30 | joint pain |
Pain in right arm, achiness in right shoulder, arm and hand Headache Fever shortness of breath/diff...
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Pain in right arm, achiness in right shoulder, arm and hand Headache Fever shortness of breath/difficulty getting a breath Nausea lethargy Body aches - neck, shoulders upper back, knees , head, general over all aches Started a few hours after vaccine was given and is still ongoing today 3/31/21. My fever is down but had fever and chills both of the last 2 nights I took Tylenol 500mg from midnight 3/29/21 and every 3 to 5 hours until about 10 pm 3/30/21
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| 67 | 2021-03-30 | joint pain |
Injection site pain; Joint pain in both hands "mild" continuing; This is a spontaneous report from a...
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Injection site pain; Joint pain in both hands "mild" continuing; This is a spontaneous report from a contactable nurse (Patient). A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL3249), via an unspecified route of administration, administered in Arm Left on 28Jan2021 14:00 as single dose for covid-19 immunisation. Medical history included hypertension and breast cancer from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole, losartan potassium (LOSARTIN), hydrochlorothiazide. On 29Jan2021, the patient experienced injection site pain and joint pain in both hands "mild" continuing. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered.
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| 67 | 2021-03-30 | back pain, musculoskeletal stiffness |
Sudden low back pain; stiffness; difficult to get comfortable; very difficult to stand up or move ar...
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Sudden low back pain; stiffness; difficult to get comfortable; very difficult to stand up or move around; very difficult to stand up or move around; bedridden; This is a spontaneous report from a contactable consumer. A 67-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9266, Expiration date: Unknown) on 09Feb2021 at 24:00 via an unspecified route of administration in the right arm at SINGLE DOSE for COVID-19 Immunization in the hospital. The patient's medical condition included Breast cancer from 2020, NDPH (New daily persistent headache) since 1973 and Food intolerances not anaphylactic reactions: Gluten, peppermint from an unknown date and unknown from ongoing. The patient's concomitant medications were not reported. The patient previously had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261, Expiration date: Unknown) on 19Jan2021 at 11:30 via an unspecified route of administration in the right arm at SINGLE DOSE for COVID-19 Immunization. The patient had not used any other vaccine in four weeks and not in two weeks. On 10Feb2021 18:00 the patient had sudden low back pain and stiffness beginning about 36 hours following 2nd vaccination. (The first 36 hours, I felt great-seemed to have extra energy. No injection site pain.) Pain and stiffness made it difficult to get comfortable, and it was very difficult to stand up or move around. I was bedridden for about 24 hours. Today is day 5 after vaccination, and I still have some pain/stiffness albeit much less severe. The patient had not tested for COVID-19 prior to vaccination and post vaccination. The patient did not receive treatment medication. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.
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| 67 | 2021-03-30 | joint swelling | EXTREME PAIN IN THIGHS SWELLING OF THE TONGUE SWELLING OF THE LEGS SWELLING OF THE ANKLES |
| 67 | 2021-03-30 | muscle pain, joint pain | Generalized muscle and joint pain, headache, fever, nausea, chills, fatigue |
| 67 | 2021-03-31 | neck pain |
Pressure Headache that lasted 12 days, right facial tingling around day 5, visual disturbances on d...
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Pressure Headache that lasted 12 days, right facial tingling around day 5, visual disturbances on day 2, foggy thinking 10-12 days, fever 100.6 after 30 hours, body aches lasted 48+ hours, irritability for 7+days, neck pain lasting 7-10 days with thoracic pain lasting 12-14 days, left arm soreness lasted 4-5 days, loss of appetite lasted 2 days
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| 67 | 2021-04-01 | joint pain |
No reaction atbthe injection site, but approximately February 9, 2021, I began feeling pain I my upp...
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No reaction atbthe injection site, but approximately February 9, 2021, I began feeling pain I my upper right beast area and upper right shoulder blade area after a trip and fall the evening of February 8. While the pain was deep, I also developed a surface rash in both areas. Having had a mild case of shingles in 2008, I suspected it was a recurrence and made a doctor's appointment. Diagnosis was confirmed. Suspicion is that Covid vaccine reawakens dormant virus.
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| 67 | 2021-04-01 | joint pain |
Prolonged pain in shoulder, in the area of the left side of clavicle. Pain lasted for approximately...
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Prolonged pain in shoulder, in the area of the left side of clavicle. Pain lasted for approximately 2 weeks.
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| 67 | 2021-04-01 | muscular weakness | Reported leg weakness, headache, and chills. |
| 67 | 2021-04-02 | muscle pain |
arm pain/somewhat sore/very sore arms; Body aches; Sweating/woke up sweating wet; fever; Chills; mus...
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arm pain/somewhat sore/very sore arms; Body aches; Sweating/woke up sweating wet; fever; Chills; muscle aches; tiny cough; froze/cold all day; This is a spontaneous report received from a contactable consumer (patient) in response to Non-HCP letter sent to consumer. This 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03FEB2021 11:00 AM (24 hour clock) at single dose (lot: EL9262) at Arm Left for COVID-19 immunisation. Medical history was not reported. Concomitant medications were none. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (lot: EJ1685) on 30Dec2020 for COVID-19 immunisation and experienced got covid from 07Jan2021, No reaction. The patient experienced arm pain/very sore arms, 2nd shot Some what sore, Body aches, Sweating/woke up sweating wet, Tiny cough from 03FEB2021, no treatment received. The patient also experienced Chills/2nd shot froze 48 hours treated with Tylenol, Fever treated with Tylenol and Advil, Cold all day from 03FEB2021 and treatment with Tylenol and Advil. No admission to the hospital due to the events. The patient experienced some muscle aches as well. The reported issue occurred after use of Pfizer product. The patient and her husband both got covid dalp after shot as many of their friend have, husband was hospitalized. The outcomes of the events was recovered. Information on Lot/Batch number was available. Additional information has been requested.
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| 67 | 2021-04-02 | muscle pain |
fever of 103.8; headache; Chills; achy muscles; nausea; weak; dizzy; This is a spontaneous report fr...
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fever of 103.8; headache; Chills; achy muscles; nausea; weak; dizzy; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9267; expiry date: unknown), via an unspecified route of administration on 18Feb2021 at 15:15 (at the age of 67-years-old) on Right arm at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No Allergies to medications, food, or other products. The patient previously took first dose of BNT162B2 (lot number: EL0142) on 28Jan2021 at 03:45 PM (at the age of 67-years-old) on Right arm for COVID-19 immunisation. It was reported that the patient had experienced chills, fever of 103.8, headache, nausea, achy muscles, dizzy weak on 20Feb2021 at 07:00. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. Outcome of all the events was recovering.
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| 67 | 2021-04-03 | armpit pain |
Skin reaction red rash under both armpits: Caller stated the event started the first day after the f...
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Skin reaction red rash under both armpits: Caller stated the event started the first day after the first shot then still having reaction from the second shot; Skin reaction red rash under both armpits; Ears would get warm feeling very hot; after the second shot the flare up was quicker; skin is dry from being inflamed; skin is dry from being inflamed; blossoming under the armpits and they are rosy red but no blisters; hurt was always in the center of armpit not in the armpit; This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 02Mar2021 14:00 (Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization. The patient previously had first dose of BNT162B2 (lot number: EM9809) on 09Feb2021 in the bicep left arm upper muscle for COVID-19 immunization. Medical history included surgery from an unknown date and unknown if ongoing. Concomitant medication included vitamin D3 taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took Miralax. The patient previously had first dose of BNT162B2 (lot number: EM9809) on 09Feb2021 in the bicep left arm upper muscle for COVID-19 immunization and Pneumonia shot and never had swelling. The patient had rosy arm pits red rash and sometimes get a reaction in ears, if it flares up and gets hot. The patient stated, "For 5 weeks I've been taking children's Benadryl. I had a quicker reaction with the second dose than I did the first one but I still had some lingering effects from the first dose when I got the second. How long do these side effects usually last?" The patient had second COVID 19 vaccine and also had first one. The first dose was on 09Feb21 and she had swelling in arm after shot and has been using a cool cloth on it and was better by the next day. The patient still feels it though and it has been five weeks. The patient tries to turn arm and can still feel it but it was not bad. A day later she had her first skin reaction which was a red rash under both armpits. The patient waited because she wanted to see what reactions she would have with second dose. The reaction from first dose happened for three weeks. The patient has been taking liquid Benadryl everyday sometimes during night and also cold wet compresses in armpits has helped with inflammation. The primary care doctor and talked to the patient to see if she should try some other medication before second shot and the nurse recommended she should not get second shot that she should see an allergist. The patient got second shot and talked to nurse there. The nurse told the patient she would have to come back at least four days after the second shot was due or it would not work together. The patient went ahead and got the vaccine and it has not been life threatening as of now. The patient saw an allergist three days after second shot. The patient had rosy red inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly bilateral armpit and then sometimes ears would get hot. The patient would take Benadryl. The physician told the patient to try to take Allegra 24 hours but the patient stated it did not work that it only worked for 12 hours and not the full 24 hours. The patient took the Allegra medication on Sunday morning and that it worked for her for about 12 hours and she knew she could not take any more Allegra but the Benadryl seemed to help. The allergist felt she made the right decision since her events are not life-threatening since it is not respiratory. The allergist saw her armpits agreed the children Benadryl was working and that she should stick with that. The patient stated, it is not going away been like this the whole time since 02Mar2021 and still having a reaction in her armpits. The patient stated after the second shot the flare up was quicker because first shot was already in system still. It was not a flare up like when someone can not eat seafood and stuff like that. The patient still has a rosy armpit. The patient has not seen her doctor since last year when she had a physical. The patient would inform her doctor about these events. The patient stated she is really blossoming under the armpits and they are rosy red but no blisters and her skin is dry from being inflamed all this time. She squeezes a rag under her armpits and that it is better during the day than at night, it is worse at night. The patient was only taking 20 mL of Benadryl in the morning and then evening before bed. The patient stated, "the first shot right at the beginning she had to take Benadryl in the middle of the night as well but got to where she was taking it 12 hours apart before second dose." The patient hopes she is not having to walk around with compresses in the summer as it is easier when it is cold and that she hopes this fazes. The patient was noticing since she had not taken a shower or hot bath this morning that she had rosy red cheeks like a rosy red U on her face. The second shot she asked the nurse to give in her back upper part of bicep in arm muscle since it was a better location and it did not swell up and it did not hurt. Caller stated the nurse the first time gave the shot like when you see people getting shots on tv they put it really high up in muscle. The patient considered the event as medically significant and that it is ongoing and has worsened. The hurt was always in the center of armpit not in the armpit. The past couple of days her skin has been dry. She has used hand cream but is afraid to put anything else on it because of reaction. Just annoying. The patient will probably put cream on it so it does not crack, it is very dry and it has not been dry like this. The patient has been putting water on at night which could have dried it out. Some days is worse than others more red. This is persisting. Soreness in arm happened right after first shot. The shot was given in the proper way but seemed like more of a reaction. The second shot is much better and that she does not feel it at all. The patient can still feel where the vaccine went in left arm. It was annoying but it does not keep her from moving her arm and it has been five weeks. Since it is not going away it is serious. The patient was not taking Benadryl in middle of day like before but it is itchy so she is going to go out in the cold and work in yard. Before first week or two she would use cool compresses all day and take Benadryl during day and then at night it petered out. The patient was hoping it will fade out eventually. The patient did not want to double up on Allegra as she is not sure what the reaction would be. The medical ingredient was Fexofenadine HCL 180mg antihistamine. The patient only took one pill as it did not work. 24 hour Allegra, 180mg antihistamine 15 tablets per box. The patient was taking Children Benadryl 20mL and would take at least every 6 six hours and was trying to hold off to now taking it 12 hours and will use cold compress if she has to. The patient usually takes Zyrtec for seasonal allergies like dust. She took no Zyrtec at all for either shots. She felt the Benadryl worked better and quicker. The patient was at the Allergist she asked what is in this vaccine like what chemical. She looked up the ingredients but did not understand. Her friend told her Polyethylene glycol was in both the Pfizer and Moderna vaccine. The patient had rosy red, inflamed armpits and when it would flare up her ears would get warm feeling, very hot, but not anywhere else and it was just mainly her bilateral armpits and then sometimes ears would get hot. The patient stated her primary care physician told her to try to take Allegra 24 hours but caller stated it did not work that it only worked for 12 hours and not the full 24 hours. The patient stated she took the Allegra medication on Sunday morning and that it worked for about 12 hours and she knew she could not take any more Allegra. The patient stated the medical ingredient was Fexofenadine HCL 180mg antihistamine. The patient stated she only took one pill as it did not work. Sample of the product was available to be returned. The packaging was sealed and intact. The outcome of the event "Ears would get warm feeling very hot" and "after the second shot the flare up was quicker" was unknown. The outcome of the rest of the events was not recovered.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of events rash and erythematous rash (allergy context) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-04-17 | joint pain, joint swelling |
Bottom of heel hurt/she is not experiencing any arm pain. It is in her ankle and feet; discoloration...
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Bottom of heel hurt/she is not experiencing any arm pain. It is in her ankle and feet; discoloration inside of the left ankle and bottom of heel; she is not experiencing any arm pain. It is in her ankle and feet; Hallucinations; ankle swollen; This is a spontaneous report received from a contactable consumer (patient). This 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 25Mar2021 10:00 (Batch/Lot Number: EN6208; Expiration Date: Jun2021) as a single dose for COVID-19 immunization. Patient received the first dose on 04Mar2021 10:00 in the left arm (Batch/lot number: EN6200, Expiration Date: Jun2021) and she had headaches, arm ache, and hallucinations which would go and come. When she would try to sleep, the hallucinations would go and come but then the hallucinations stopped prior to getting the second dose. Headaches started a couple of days after the first dose probably started the next day and started coming and going. This stopped prior to the second dose probably a week or week in a half maybe two weeks before getting second dose. The headache only lasted about half a day, it wasn't that bad. She recovered completely. Arm sore, red only happened with the first dose as her arm did not hurt at all after the second. This started the next day or even the same day but she kept it comfortable and probably stopped within the first week and it did not come back either. She has recovered completely. Sharp pain through arm go and come. This started after the first dose so in that week or week in a half area and it stopped about at least a week before the second dose somewhere in that period of time. She has recovered completely. Hallucination: she was laying down at night and something would come across her head that she was not thinking. It started right after the first dose probably first, second, or third night but it stopped like all the rest of it in same period of time. She had recovered completely prior to getting the second dose. Medical history included arthritis and diabetic. The patient's concomitant medications were not reported. Patient had the flu vaccination for the first time in Oct2020 or Nov2020 and did have a headache and she has never taken the flu vaccine before. The patient had side effects from the vaccine she received on 25Mar2021. Her ankle was swollen on 28Mar2021 but that went down on 30Mar2021. This has left discoloration inside of her left ankle and bottom of her heel and it was sore from 30Mar2021 and ongoing. It was not red, tender, or bruised. The bottom of her heel hurt when she put pressure on it and walked on 31Mar2021. It was ongoing but was off and on and it has worsened. She had her feet up on the bed. As treatment, patient used heat, ice, and has been elevating her feet. She called her doctor and doctor told her to keep doing it since she has been doing it since Monday. With the second shot, she is not experiencing any arm pain. It is in her ankle and feet and then the hallucinations still go and come and she sees images that come still but do not stay they just go and come. After the second dose, she had this last night and the night before last, she would not be thinking it but it would appear in her mind and she was wondering why it was doing that but she thought maybe a week or two it will stop and come down. This started on 28Mar2021, Sunday after the second dose and is still going on. Outcome of the event ankle swollen was recovered on 30Mar2021, of the event arthralgia was unknown, and of the other events was not recovered.
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| 67 | 2021-04-17 | muscular weakness, joint pain, muscle pain |
Blurred vision; Headaches; Chills; Itching rash on arms, back, neck and chest; Fainted at home, fell...
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Blurred vision; Headaches; Chills; Itching rash on arms, back, neck and chest; Fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black; Fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black; busted her lip and it was bleeding real bad; Weakness/ feeling weak; Feel weak in her arms and legs; Sweating profusely; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Aching of joints and muscles kind of like flu symptoms in shoulders and arms; Foggy Brain; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE; Dose 1) intramuscularly, administered in the left arm on 11Mar2021 (batch/lot number: EN6205) at 67 years old as a SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a Pharmacy/ drugstore. The patient's medical history included compromised immune status; respiratory illness, genetic /chromosomal abnormalities; endocrine abnormalities (including diabetes) and obesity; asthma diagnosed since childhood; diagnosed allergies, allergies (seasonal and food); food allergies included gluten, dairy, artificial sweeteners including Sorbitol and Xylitol, broccoli, cauliflower, cabbage, brussel sprouts, asparagus, all "percifirous"/ cruciferous vegetables; she also has allergies to cats, pollen, trees, grass, ragweed, mold, mildew, and dust; and allergies to Codeine, Penicillin, Sulfa, Iodine, Epinephrine, Morphine, and Clindamycin (patient does not have a manufacturer, lot or expiration to any of these medications). The patient had no family medical history. Concomitant medications included unspecified prescription medications for years which she did not feel they were relevant. On 11Mar2021, the patient experienced "weakness/ feeling weak" (weakness), "feel weak in her arms and legs" (weakness of limbs), "fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black" (faint), "fainted at home, fell, and busted her lip/ she dropped to the floor and everything was turning black" (fall), "busted her lip and it was bleeding real bad" (bleeding lips), sweating profusely (excess sweating), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (Flu-like symptoms), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (Joint pain), "aching of joints and muscles kind of like flu symptoms in shoulders and arms" (muscle pain), and foggy brain (foggy feeling in head). On 12Mar2021, the patient experienced headaches, chills, itching rash on arms, back, neck and chest (itchy rash). On13Mar2021, the patient experienced blurred vision. It was reported that after the first shot, on 11Mar2021, patient experienced weakness, then she got home and she fainted, fell, and busted her lip and it was bleeding real bad. Then she began sweating profusely. She started feeling weak 30 minutes after getting the shot. Someone took her there because she would not have been able to drive. They brought her home and she was in the kitchen. While over the sink, she started to feel weak in her arms and legs. Before she could tell her husband that she was feeling weak, she dropped to the floor and everything was turning black. She fell face first and busted her lip and it was bleeding real bad. The weakness gradually started getting a little better on 30Mar2021. She is having to walk with a cane now because of the weakness. She was not using a cane before. Two days later on 13Mar2021, she was in the kitchen again and she felt that feeling coming and her husband was able to grab her and sit her down and she did not faint but she could tell it was coming. Patient also reported that from 12Mar2021, she is getting headaches every day off and on and in different spots of the head. Sometimes it is in the forehead, top, side and back. For about a good week, she had chills and it tapered off after the first dose. Also, on 12Mar2021, she experienced itching rash on arms, back, neck and chest. They were fine bumps and they just itch. The patient was recovering from the events faint, fall, bleeding lips, excess sweating, and itchy rash; and has not recovered from the events weakness, weakness of limbs, flu-like symptoms, joint pain, muscle pain, foggy feeling in head, headache, chills, and blurred vision. Follow-up attempts are completed. No further information is expected.
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| 67 | 2021-04-17 | neck pain |
bradycardia; fainting; Head and neck ache; Head and neck ache; first dose received on 09Mar2021; sec...
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bradycardia; fainting; Head and neck ache; Head and neck ache; first dose received on 09Mar2021; second dose received on 15Mar2021; first dose received on 09Mar2021; second dose received on 15Mar2021; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the right arm, on 15Mar2021 15:00, as single dose, for COVID-19 immunisation. Medical history included psoriasis, high blood pressure, scoliosis and low thyroid. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); sertraline; sertraline hydrochloride (ZOLOFT); and levothyroxine sodium (LEVOTHYROXINE), all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported) received at age 67 years, via an unspecified route of administration in the right arm, on 09Mar2021 14:45, for COVID-19 immunisation. On 15Mar2021, the patient experienced bradycardia, was fainting, and had head and neck ache. One week after the second vaccine, in Mar2021, the patient was taken to the hospital due to the events. Treatment for the events included "had to have a pacemaker put in". The patient reported that she never had heart problems before, and she was curious if these could have ben side effects from the vaccine. The events resulted to physician office and emergency room visits, and hospitalization. The duration of the hospitalization was reported as 4 days. The events were reported as life-threatening illnesses. The patient was recovering from the events. Information about Batch/Lot number has been requested.
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| 67 | 2021-04-22 | neck pain |
Sharp pain in my upper arm, wrapping around to my triceps, into my left trapezius and up into the le...
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Sharp pain in my upper arm, wrapping around to my triceps, into my left trapezius and up into the left side of my neck. At about that same time, I developed pain in my left wrist and in the pinky and ring fingers of my left hand. Pain has continued for more than two months now despite regular stretching of the affected areas, use of a wrist brace, and applications of Icy Hot patches to my arm and upper back.
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| 67 | 2021-04-23 | joint pain |
painful knees; red bumpy rash on face; itchy eyelids, eyebrows; Mild headache; nausea; fatigue; This...
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painful knees; red bumpy rash on face; itchy eyelids, eyebrows; Mild headache; nausea; fatigue; This is spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EM9810), via an unspecified route of administration on arm Left on 10Feb2021 12:00 PM at single dose for COVID-19 immunization. The patient medical history included Systemic lupus, RA, Minimal Stage Kidney Disease, mild heart failure, allergic asthma and allergies to Nafcillin, cleocin, celebrex, fluorescein dye, lasix, bactrim, flecanide. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient Concomitant medications included Prednisone 5mg, Plaquenil 200mg, APIXABAN (Eliquis), METOPROLOL SUCCINATE (Toprolxl) taken in two weeks. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. On 10Feb2021 05:00 PM, the patient experienced mild headache, nausea, painful knees, fatigue, red bumpy rash on face, itchy eyelids and eyebrows. The patient did not receive any treatment for the events. The outcome of the events was recovered.
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| 67 | 2021-04-24 | muscle pain, joint pain |
Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; inject...
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Shaky; Muscles and nerves seemed to be locking up like almost paralyzed; swollen lymph nodes; injection site redness; severe allergic reactions; slight dizziness; severe headache; nausea; weak; tired; feverish; sweat; had pain at the Pfizer Covid 19 Vaccine injection site; right arm started to swell; chills; extreme muscle pain; certainly extreme and joint pain; Heart beat seemed to speed up; Has not been able to walk or move body in normal fashion; This is a spontaneous report from a contactable consumer (patient herself) A 67-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EP7533) a week ago via an unspecified route of administration on 02Apr2021 at 13:45 hrs on the right upper arm as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.When caller was 18 they required a booster for Small pox and caller received the small pox booster on the leg in the same site where it was given at age 5. Caller's leg swelled up to 5 times the normal size, at the time caller was 18 years old.Took a long time for swelling to go away, a couple weeks. Caller requires it hindered sports activities during this time. On 02Apr2021, the patient started reported slight dizziness, severe headache, Shakiness, nausea, weakness, tiredness, have been feverish, pain at the injection site and stated that her right arm started to swell. The patient stated that through out the night of 02Apr2021, she had extreme muscle pain, certainly extreme and joint pain that was also extreme and heart beat seemed to speed up within the first hour and by the end of the hour. On 03Apr2021, the patient stated that her muscles and nerves seemed to be locking up like almost paralyzed. The patient described the events she experienced slight dizziness and didn't worry because it wasn't major and caller was driving herself and with in an hour the dizziness got worse. Caller had severe headache and had to drive home a significant distance and the time the caller got home, she reports being shaky, dizzy, had headache, nausea, was weak and tired and must have been feverish. Caller reports she must have been feverish because she was drenched in sweat by the time she got home and it was a 2 hour drive home from the vaccine administering facility. Caller had pain at the Pfizer Covid 19 Vaccine injection site, and caller's right arm started to swell.Caller clarified that the injection site was in the right upper arm, doesn't know what the muscle is called. Caller says she couldn't see if her arm was getting red, caller has some discs out in her neck and is unable to look at the arm. Caller could feel the injection site on her right arm was swollen and swelling. Caller reports fever was gone and fever got replaced with chills later on. Caller reports there was progression of the symptoms after the first hour. Caller states the information provided thus far was the first hour of her experience and through the night a lot of other things changed and added.Through the night caller had extreme muscle pain, certainly extreme and joint pain that was also extreme. Muscles and nerves seemed to be locking up like almost paralyzed: By the next morning, after caller had the Pfizer Covid 19 Vaccination, states she was not a doctor but all of her muscles and nerves seemed to be locking up like caller was almost paralyzed. Caller reports she couldn't move, couldn't get out of bed. It took a long time to get caller's fingers and toes moving and the rest of the body, but fingers and toes were the first ones. Caller was able to kind of release from muscle cramping. Whatever was going on, caller says can't tell exactly what was going on, does not have a Doctor in the home. States the information given should cover that part of the experience. Through the night had extreme muscle pain, certainly extreme and joint pain that was also extreme: Reports since the morning after receiving the Pfizer Covid 19 Vaccine, caller has had continued muscle pain, although not as extreme, its pretty extreme, and join pain. The patient has not been able to walk or move body in normal fashion. The patient stated that she had every side effect listed on the fact sheet at the top minus the swollen lymph nodes and injection site redness and she had two of the side effects listed under the severe allergic reactions. The patient wanted to know whether it is safe to receive the second dose of the vaccine. The patient lives in an isolated area where all through COVID-19 she tried to get information from the local medical clinics and they did not seem to stay informed. Caller states she has a doctor's appointment, and she will let them know the side effects she experienced after the first dose but she is not confident in the recommendations they might provide. Patient was given a list of side effects to look for, ones they were assuming, doesn't know if the hand out was published by Pfizer or not.The hand out listed emergency kind of side effects people were experiencing.Caller reports they are over age 65 range and knew a lot of people before her who had the Pfizer Covid 19 Vaccine and said they only had injection site soreness. Caller was expecting the same reaction, caller was told by the Doctor she was in pretty good shape. Caller reports she had most all of the reactions except anaphylactic reaction of not breathing after receiving first dose Pfizer Covid 19 Vaccine. Caller is nervous about going for the second round of the Pfizer Covid Vaccine, is not sure how to proceed and would like that information. The case was assessed as serious medically significant for the event paralysis. It was reported that patient took Aspirin as treatment medication for pain. The outcome of the events was resolved for fever and nausea, resolving for swelling arm, unknown for swollen lymph nodes, Chills , Vaccination site pain, injection site redness, severe allergic reactions, sweat, shaky feelings, heartbeat increased, movement disorder and not resolved for all other events.
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| 67 | 2021-04-24 | neck pain, musculoskeletal stiffness |
cramps; her stiff neck; She couldn't move her neck, it was very painful; She was breaking out in swe...
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cramps; her stiff neck; She couldn't move her neck, it was very painful; She was breaking out in sweats; She is still cold/She is freezing cold; She is loosing her hair. clumps of hair falling out.; sinus headache; had issues with her thyroid; sinusitis like when she had COVID; palpitation; nausea; feeling achy like you have a flu/ aches and pain; fever; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2, via an unspecified route of administration, administered in arm left on 26Mar2021 15:00 (Lot Number: EN6208) as single dose for COVID-19 immunisation. Medical history included atrial fibrillation on an unknown date. Caller added she takes medication for Atrial Fibrillation. She had Covid at the end of Dec2020. She was sick and out of work for 6 weeks. She had a headache since she was diagnosed with Covid. Caller had a funny sensation in her sinuses after the injection. It was a weird feeling, just like when she had Covid. She had breathing issues with her Covid diagnosis. Her headache, cough, and breathing issues kept her out of work for 6 weeks. She had a lot of allergies. The patient's concomitant medications were not reported. The patient experienced headache on 26Mar2021 with outcome of recovered with sequelae on 27Mar2021, achy, chills, fever, nausea on 27Mar2021 with outcome of recovered with sequelae on 29Mar2021, palpitation, sinusitis like when she had covid, cramps, stiff neck, couldn't move her neck, it was very painful, she was breaking out in sweats, still cold/ freezing cold, loosing her hair/ clumps of hair falling out, sinus headache and had issues with her thyroid on an unspecified date with outcome of unknown. The clinical course reported as follows: Patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE last 26Mar2021 and scheduled to get the 2nd dose on 16Apr2021. Patient experienced headache, sinusitis like when she had COVID, nausea, feeling achy like you have a flu, fever chills, cramps ,aches and pain, palpitation. Patient had tested positive for COVID last 28Dec2020 that lasted for 6 weeks. Asking if 2nd dose will be more intense when it comes to reactions and if she can safely have the 2nd dose. She will see her cardiologist due to chest palpitations. She worked and had her first Pfizer Covid-19 vaccine 26Mar2021. She had Covid at the end of Dec2020. She was sick and out of work for 6 weeks. She had a headache on Friday immediately after her injection. Then was okay. On Saturday morning after waking up, she felt achy, nauseous, had a fever, chills, and a headache. On Sunday she was not feeling great. Even into Monday, she had fever and chills and felt the same as when she had Covid. Caller added she is not supposed to get sick. Caller states weighs 160 pounds, which she shouldn't be. After the shot she felt a sinus headache. Funny sensation in her sinus's just like it was when she had COVID. Once she had the shot, the original headache went away along with her stiff neck. She couldn't move her neck, it was very painful, it still happens. And she had breathing issues with her Covid diagnosis. Her headache, cough, and breathing issues kept her out of work for 6 weeks. Caller had lasting effects from Covid, but didn't know if these symptoms were related to the shot. She was breaking out in sweats. She was still cold. There was something going on. She was having her Vitamin D level and thyroid checked. She was loosing her hair, clumps of hair falling out. She had issues with her thyroid. Caller wondering if the vaccine was the cause. She was freezing cold. She hadheart palpitations and was seeing her Cardiologist next Thursday. Caller received the vaccine because she had Covid and didn't want to get it again. She was pretty sick. She worked around people and didn't want to be in a situation because not everyone wants to get the vaccination. Treatment of events included: She had not been to the doctor for this, she just jumped into bed and took Tylenol. The events didn't require a visit to emergency room or physician office. No follow-up attempts are needed. No further information is expected.
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| 67 | 2021-04-26 | joint pain | Diarrhea, joint aches, chills |
| 67 | 2021-04-27 | weight decreased |
multiple er/admissions from february through april 27. pt deceased on 4/27/21 2/25/21 known past m...
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multiple er/admissions from february through april 27. pt deceased on 4/27/21 2/25/21 known past medical history of hypertension and hypothyroidism. Status-post spinal decompression due to stenosis. The patient then developed worsening issues with a surgical site infection. Patient has had numerous bouts of C diff. Staff notes patient is to have GI consult in the near future. Patient is seen today in her room. Patient was once again diagnosed with C diff and is currently being treated with antibiotics. Patient notes no bowel movements today. Patient has not had any issues with intake recently. The patient's weight has declined partially due to likely diarrhea. Patient's blood pressure continues to be monitored closely as it has been on the lower side of normal. Patient's potassium 2.9 on CMP. Patient's other care and therapies were reviewed. 2/28/21 Patient was admitted the hospital after found to be anemic at skilled care facility where she is being treated for C diff infection recurrent Lea. Patient was transfused. Patient was also found to have pneumonia/lung mass. Patient has struggled with electrolyte dysfunction. Patient had to be transfused a second time. Patient did well with second transfusion. Patient was found to be hypokalemic. Patient did well with potassium replacement. The patient was advised will have to do outpatient PET scan. Patient was found to have positive blood cultures as well 4/26/21 68 y.o. female who presents from nursing home with complaints of elevated white blood cell count. According to nursing home records patient had CBC checked on Saturday 04/24/2021 and her WBC count was found to be 50,000. At that point in time no other orders were given and patient was not sent in for evaluation. CBC was repeated this morning and WBC count found to be in the 70,000s. Patient was sent in for evaluation this morning. In talking with the patient, she denies any runny nose, sinus drainage or cough. Patient does report shortness of breath. Patient denies any chest pain or palpitations. Patient denies any dysuria, hematuria, fevers, or chills. Patient denies any nausea or vomiting. Patient does report diffuse pain across the lower abdomen. She does report chronic diarrhea. Patient had C diff stool checked on 04/13/2021 and was negative. (4/26 cdiff positive) Of note patient does have known lung mass that was seen on chest x-ray and PET scan. Patient reports that she does not want anything done and understands it could be cancer. And continuing to question patient, she reports she wants to be a DNR and does not want any aggressive measures.
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| 67 | 2021-04-28 | flank pain |
Client had first Pfizer injection on 3/24/2021. The client presented to the emergency department on ...
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Client had first Pfizer injection on 3/24/2021. The client presented to the emergency department on 4/27 with a fever, generalized weakness, body aches, headache and right flank pain. She had lithotripsy and a right ureteral stent replacement the day before, 4/26. She is on ciprofloxacin. Urine Analysis was consistent with a UTI. Most recent positive urine culture grew out multidrug-resistant Klebsiella. The patient will be admitted to the hospital service for further evaluation and treatment.
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| 67 | 2021-05-06 | neck pain, back pain |
fainting; Severe head, neck and back pain; Severe head, neck and back pain; Severe head, neck and ba...
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fainting; Severe head, neck and back pain; Severe head, neck and back pain; Severe head, neck and back pain; nausea; vomiting; This is a spontaneous report from a contactable consumer, the patient. This 67-year-old non-pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8737) via an unspecified route in the right arm on 19Apr2021 at 14:45 (at the age of 67-years-old) as a single dose for COVID-19 immunization. Medical history included chronic severe tension headaches and allergies to some antibiotics (unspecified products). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination. Concomitant medications included unspecified supplements and herbals. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7534) on 27Mar2021 at 14:45 in the right arm as a single dose for COVID-19 immunization. On 20Apr2021 at 02:30, the patient experienced severe head, neck and back pain, combined with nausea, vomiting and fainting. There was no treatment received for severe head, neck and back pain, combined with nausea, vomiting and fainting. The clinical outcomes of severe head, neck and back pain, nausea, vomiting and fainting was recovering. The patient was not tested for COVID post vaccination.
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| 67 | 2021-05-07 | musculoskeletal chest pain |
Hot flash; Headache; severe body aches over whole body/ localized around rib cage; severe body aches...
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Hot flash; Headache; severe body aches over whole body/ localized around rib cage; severe body aches over whole body/ localized around rib cage; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EM9810) via an unspecified route of administration at left arm on 03Feb2021 17:45 (67-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included high blood pressure, COPD, and allergies to Penicillin, various blood pressure meds. Concomitant medications included ongoing atenolol (TENORMIN) for high blood pressure, ongoing ergocalciferol (VIT D), ongoing acetylsalicylic acid (BABY ASPIRIN), ongoing Multi Vitamin (unspecified). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231, the second letter need to read) via an unspecified route of administration at right arm on 13Jan2021 17:50 (67-year-old at time of vaccination), at single dose, for COVID-19 immunization. There was not prior vaccination. On 04Feb2021 02:00, the patient experienced hot flash (Seriousness criteria: Not Serious). She had headache on 04Feb2021 in middle of night and severe body aches (Seriousness criteria: Not Serious) on 04Feb2021. Next day severe body aches over whole body then by end of day pain was localized around rib cage. Adverse events did not result in emergency room visit or physician office visit. Patient did not have COVID-19 prior vaccination. Patient did not test COVID-19 post vaccination. No therapeutic measures were taken as a result of the events. The outcome of the event hot flash was recovered on 04Feb2021; headache and "severe body aches over whole body/ localized around rib cage" were recovered on 05Feb2021. Follow-up attempts are completed. No further information is expected.
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| 67 | 2021-05-07 | weight decreased |
cardiac enzymes were extremely elevated; Weight from 223 pounds to 211 pounds in 2 months; No appeti...
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cardiac enzymes were extremely elevated; Weight from 223 pounds to 211 pounds in 2 months; No appetite; Sleep pattern is bad/she cannot fall asleep until 0400 and then wakes right back up around 0800; Feels rough with fine bumps at times; Feels rough with fine bumps at times; Itches at times; Rash on outer aspect of arm; Tightness, uneasiness in chest; Palpitations, Fluttering in Chest; Palpitations, Fluttering in Chest; Easily Winded; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose on 16Mar2021 (Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), then the second dose on 07Apr2021 (Batch/Lot Number: ER8730; Expiration Date: 31Jul2021), both via an unspecified route of administration, at the age of 67-years-old, administered in arm left as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from 2002 and ongoing, ongoing diabetes mellitus, penicillin allergy from an unknown date and unknown if ongoing, became really sick, really fast, uncertain if was Covid 19 from Feb2020 to an unknown date and chest discomfort from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)), glyceryl trinitrate (NITROGLYCERIN), both taken for chest discomfort; dulaglutide (TRULICITY) taken for an unspecified indication, all from an unspecified start date and ongoing. The patient previously took morphine and codeine and experienced drug allergy. The patient was at her eye doctor on 02Apr2021 and decided afterwards to have her grandson take her to the Emergency Room (ER) for some tightening and uneasiness she had been having in her chest over the preceding days. She also felt some palpitations, they were fast, then slowed down; did not feel labored. She went to the ER and was there for 8 hours. They told her that her cardiac enzymes were extremely elevated. After the cardiologist reviewed her results she was allowed to go home. She went to her regular cardiologist on 05Apr2021. That cardiologist went over her tests results and said that while it was not normal results for her he didn't find them too worrisome. He stated that just because her enzymes are elevated does not mean she is in trouble. He scheduled her for a Dobutamine Stress Test on 07Apr2021. She has been trying to get the results of this stress test from the doctor's office but has not been successful in doing so. Says that once she completed the Stress Test on 07Apr2021 she went to get her second dose of the Covid Vaccine. She was still having her symptoms when she got her second vaccine and they have continued since. She saw her endocrinologist who went over blood work with her. The endocrinologist told her that her blood glucose level was very good and her A1c was a 5.5. The endocrinologist was concerned because usually the A1c is between 6 and 7. Patient was 5 foot 6- and one-half inches. Tightness, Uneasiness in chest: Stated it is not pain, just an uneasy, uncomfortable, fluttering feeling. Palpitations, Fluttering in chest: Not a labored feeling, goes fast, then slows down, not constant. Rash on outer aspect of arm: Extends from her wrist to about 2-3 inches below her elbow. Outside of arm, not on the inner part of her arm. Feels rough with fine bumps at times; then will feel smooth again. Itches at times. She uses calamine lotion, which does help to relieve the itching and smooth the skin. Stated it eventually does come back though. Easily Winded: She has had respiratory conditions all of her life. This winded feeling, she has been having is different than that she stated. She gets the fast heartbeat really quick, can almost hear it; becomes winded and sits down. The episodes last about 15 minutes. She has had no appetite; she has lost almost 15 pounds in 2 months. Her weight was 223 pounds 2 months ago and now weighs 211 pounds. She mentioned her sleep pattern is bad. Some days she cannot fall asleep until 0400 and then wakes right back up around 0800. The patient underwent lab tests and procedures which included blood glucose: 100 on 22Apr2021, blood pressure measurement: 128/62 on 21Apr2021, body temperature: 97 degrees fahrenheit on 21Apr2021, haemoglobin: 5.5 on Apr2021, heart rate: 78 on 21Apr2021, myocardial necrosis marker: extremely elevated on 02Apr2021, oxygen saturation: 98 % on 21Apr2021. Therapeutic measures were taken as a result of rash on outer aspect of arm, Feels rough with fine bumps at times and Itches at times. The outcome of the events Itches at times, Feels rough with fine bumps at times, Rash on outer aspect of arm, Easily Winded was not recovered; Palpitations, Fluttering in Chest and Tightness, uneasiness in chest was recovering, while of the rest was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the events cannot be excluded. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 67 | 2021-05-10 | muscle pain |
Low grade fever; strong muscle aches; still cannot sleep.; This is a spontaneous report from a conta...
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Low grade fever; strong muscle aches; still cannot sleep.; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EM9810, Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 06Feb2021 10:00 as single dose for covid-19 immunisation. Medical history included osteoporosis, BRCA 2. patient had known allergies for Sulfa and ceclor. Concomitant medication included estradiol. The patient previously took first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number EL3247), via an unspecified route of administration, on right arm on 15Jan2021 04:30 PM at single dose for COVID-19 immunization. On 06Feb2021 22:00, patient experienced Low grade fever and strong muscle aches throughout body that were so bad as she has not been able to sleep. Patient was not pregnant at the time of vaccination. Patient did not received treatment for the adverse event Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequelae.
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| 68 | 2020-12-31 | muscle pain |
on dec 22 I felt some myalgias, chills, fatigue, HA --quite normal. That evening, noted small amoun...
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on dec 22 I felt some myalgias, chills, fatigue, HA --quite normal. That evening, noted small amount swelling R hand --I iced and took acetaminophen. By Dec 25, hand very swollen and painful with decreased ROM all fingers
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| 68 | 2021-01-02 | joint pain | Exhaustion Sleepiness Dizziness Joint pain |
| 68 | 2021-01-04 | joint pain, muscle pain |
arm was hurting/very sore arm; have a really bad headache; teeth ache; muscle and joint pain; muscle...
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arm was hurting/very sore arm; have a really bad headache; teeth ache; muscle and joint pain; muscle and joint pain; chills; low grade fever 99.7; sore throat; congestion; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 3 ug/ml) Batch/lot number: EL1284, on 29Dec2020 12:33 single dose on left arm for COVID-19 immunization. Medical history included Blood pressure high which diagnosed a long time ago, probably when she was 45 years old, though it could have been when she was 42 or 43, probably earlier, 25 years ago, so put when she was 42; hemochromatosis diagnosed about 25 years ago; Arthritis; Cluster headaches; low thyroid and she didn't take medication for this, it wasn't low enough; COVID-19 in Mar2020. Concomitant medication was none. The patient received the Pfizer covid vaccine yesterday (29Dec2020) and she called the line to report the side effects today. She said she had covid around the Easter time and donated her plasma also for antibodies. She said after getting the vaccine yesterday she was feeling worse, have a really bad headache, teeth ache, arm was hurting woke up due to that in the night, really bad headache, muscle and joint pain, chills , low grade fever 99.7 , sore throat and congestion. The patient received the vaccine through work, and was not prescribed it from a provider. She had her shot at 12:33PM yesterday (29Dec2020), after lunch. Her vaccine was given to her at the hospital where she worked, which was not a military hospital. Her side effects were that she developed a headache, also her teeth were aching, and then last night around 04:00AM in the morning she woke up with a very sore arm and worse headache. She said she also had muscle and joint pains, chills, and fever. She said now she still had a headache, and still didn't feel good. Treatment received for the events included Ibuprofen and Tylenol. Ibuprofen was clarified to being generic Ibuprofen prescription in a pharmacy bottle with EXP 3 09Mar2021 and NDC: 67877032005. She said that the strength of this medication is 600mg, and she just took one last night by mouth at about four in the morning. She says she also took Tylenol before bed, 500mg, this is the name brand product. UPC/LOT/EXP: unknown, she didn't have it with her she said it was in date and was brand new, in to go packs. She said that her teeth aching was gone, she still had her headache, muscle pain, fever, and her arm hurt. She said she did take another Tylenol a half hour ago or 45 minutes ago. Her low grade fever temperature was 99.7 degrees Fahrenheit. She had COVID-19 before, she tested positive for COVID at Easter time, this was in March, they did a PCR nasal swab. She had two positive tests and then a negative test because they had to retest her to get plasma, she had to be negative before she could get plasma. She also had an antibody test a couple months after she had COVID, that showed she had 27 antibodies. She had COVID, then a couple of weeks later she gave plasma, and then a few weeks later had the antibody test that showed she had the 27 antibodies. The outcome of teeth ache was resolved. The outcome of headache, muscle pain, fever, and her arm hurt was not resolved. The outcome of other events was unknown.
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| 68 | 2021-01-04 | muscle pain |
positive for Covid with symptoms; positive for Covid with symptoms; positive for streph; positive fo...
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positive for Covid with symptoms; positive for Covid with symptoms; positive for streph; positive for influenza; This is a spontaneous report from a contactable physician and nurse. A 68-year-old female patient received bnt162b2, via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced positive for COVID with symptoms, positive for streph and positive for influenza in Dec2020. Additional Context: caller stated that she had a patient that got Covid vaccine on 17Dec2020 who was complaining of muscle aches, no fever, sudden loss of taste and smell in the last 24 hours, sore throat and a cough. Stated that she cannot attribute the cough to the vaccine. Stated that she was screened for COVID, streph and influenza. Stated that she was positive for covid and streph. Stated that she does not think that and wanted to know if the vaccine would cause a positive from a rapid test. Outcome of the events was unknown. The Lot/Batch and expiry date has been requested.; Sender's Comments: The reported positive for COVID with symptoms after immunization with BNT162B2 is considered related to the suspect, BNT162B2.
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| 68 | 2021-01-07 | musculoskeletal discomfort, muscle pain |
1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight he...
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1-2 minutes after injection: lip tingle, bi-lat side back of tongue, some neck discomfort, slight headache, eyelid drop-bi-lat. Lasted 30 minutes. Day 2- symptoms returned approx 10:30 am - 3:00 pm. Nore intense included dizziness, shakes, overall malise, chest tightness. Later that day, mild diarrhea, mikd nausea. Day 3- woke with wheezing. Symptoms all continued for next 10 days off and on. The lip, tongue seemed to get shorter and shorter in duration. Also has mouth watering. Afternoon would bring on overall malaise issues. 2nd and 5th day, the worst. On 3 day went to urgent care, prednisone 40 mg x days, pepcid, zyrtec. Back to urge t care day 6, Ed day 8. Day 14 abd 15 awful chills, muscke ache and shaking.
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| 68 | 2021-01-12 | muscular weakness |
Pt. reported leg weakness "similar to when my blood sugar was low". Pt. had sugar containing candy ...
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Pt. reported leg weakness "similar to when my blood sugar was low". Pt. had sugar containing candy on person and was advised to ingest it. Pt. observed for additional 15 minutes and dismissed in stable condition thereafter.
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| 68 | 2021-01-13 | musculoskeletal stiffness |
neck stiffness; coughing with production of white mucous; felt like she couldn't breath with tightne...
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neck stiffness; coughing with production of white mucous; felt like she couldn't breath with tightness for about a half hour; felt like she couldn't breath with tightness for about a half hour; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot /batch and expiration date unspecified), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got the vaccine yesterday (07Jan2021) and that a couple of hours later she began to experience neck stiffness, coughing with production of white mucous and felt like she couldn't breath with tightness for about a half hour. The patient was asking if this was normal. Outcome of events was unknown. Information on the lot/batch number has been requested.
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| 68 | 2021-01-13 | muscle pain |
Most concerning was dizziness to the point of almost fainting. This happened 2 times. Once on the fi...
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Most concerning was dizziness to the point of almost fainting. This happened 2 times. Once on the first day after injection and once on the second day after injection. Other S.C. were fatigue, muscle aches, chills, indigestion and sore arm. No fever noted.
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| 68 | 2021-01-17 | joint pain |
Migraine headache on waking days 1, 2 and 3. Joint pain, nausea, lack of appetite, dizziness on day ...
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Migraine headache on waking days 1, 2 and 3. Joint pain, nausea, lack of appetite, dizziness on day 2. Same symptoms to a lesser extent Day 3. Day 4 no symptoms.
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| 68 | 2021-01-18 | joint pain, muscle pain |
Started with uncontrollable chills that lasted 1 hr , Fever. The next day ( saturday)tiredness , h...
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Started with uncontrollable chills that lasted 1 hr , Fever. The next day ( saturday)tiredness , headache joint pains , muscle pains , chest pains and nausea as well as Fatigue . I started taking Tylenol 500mg po q 6 hrs and that improve the sxs. The site of the injection was extremely red and swollen as well as lymphadenopathy underneath the left arm ( site of injection). The next day ( sunday) I noticed a swelling underneath the axilla going on top of the bra with blood exudate and looked as if I had bumped an object. The weakness continued during the next week and slowly the tiredness got better ( TOOK AT LEAST 7-10 DAYS).
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| 68 | 2021-01-18 | muscle pain | Fever muscle aches headache nausea |
| 68 | 2021-01-20 | joint pain | Nausea, joint pain, fever, chills, fatigue. 2 days duration |
| 68 | 2021-01-20 | back pain |
Severe posterior headache and lower midline back pain. 68 yo female with PMH cognitive changes since...
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Severe posterior headache and lower midline back pain. 68 yo female with PMH cognitive changes since admission for Sepsis (6/2020), chronic headaches, right sided HL, GAD, NA fatty liver disease, Osteoporosis p/w headache back of her head after receiving the COVID immunization. Per Daughter Pt reported feeling unwell while leaving the vaccination clinic. They wet back to the clinic and Pt laid down for a while and was given a snack. She then reported she felt well and wanted to go home. Between the clinic and the car she felt unwell again and was directed to the ED. Per Pt HA at back of head along with mild dizziness initially. Dizziness has now resolved. She took Tylenol at 1100 today for HA but does not remember if she took any more Tylenol since then. Pt does not remember when she last ate. Per Daughter she last ate at 10:30 today. She was supposed to have lunch at one but someone forgot. Pt has a family member with her at all times since her cognitive impairment this past summer. She reports regular HAs are usual for her ever since her "brain injury" (Pt hospitalized for Sepsis July 2020) Denies dizziness, denies visual changes, no photophobia. Given Acetaminophen and some food. RBS: 94 Pt reports that the headache is now at the front of her head. Pt eating a sandwich, calm, in a good mood. Feels much better. Headache resolved prior to discharge.
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| 68 | 2021-01-21 | joint pain |
Facial swelling within 20 minutes after inoculation. Pain in left arm radiating into wrist and hand ...
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Facial swelling within 20 minutes after inoculation. Pain in left arm radiating into wrist and hand - unable to open our close hand. Lasted until next morning.
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| 68 | 2021-01-21 | joint pain |
I immediately sat down for 1 hour, felt I had something , like i felt possible slight chest tightnes...
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I immediately sat down for 1 hour, felt I had something , like i felt possible slight chest tightness. I say I was fine until 3-4 hours later, I had extreme headaches. At 430pm, I still had the headaches and I took Tylenol 500mg. At night my headache got worse and it felt like I had the flu. I then went to bed and when I woke up my left arm felt intense like hornets and it was swollen. I then took another Tylenol and Ibuprofen 600mg. At 4am, I felt awful and horrible. I had joint pain with aches, felt nauseated. I called my PCP and he told me to take Prednisone 10mg. My fever was 101.4F. By the night my fever was gradually coming down and it was 102F. By the next day I felt much better. I also had Covid-19 on March 2020 and also got tested for antibody test in July 2020. I spoke with my PCP and he is recommending I do not take the 2nd dose injection.
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| 68 | 2021-01-21 | muscular weakness, neck pain |
Approximately 20 minutes after injection, - patient developed chest pain radiating to the neck - mi...
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Approximately 20 minutes after injection, - patient developed chest pain radiating to the neck - mild, dull pain (3 out 10 pain score) - weakness in both arms - shortness of breath PMHx - Had COVID-19 in July 2020
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| 68 | 2021-01-21 | muscle pain, joint pain | headache( did not take anything yet) chills tiredness muscle/joint pain injection site pain |
| 68 | 2021-01-24 | muscle pain, musculoskeletal stiffness, muscular weakness, neck pain, weight decreased, joint pain, groin pain |
Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aph...
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Patient is a 68yo female with a PMH s/f of osteoarthritis, CHF, TIA with right limb weakness and aphasia and HTN presenting with a 1 week history of bilateral upper and lower extremity pain, stiffness and weakness. Patient states that she received the Pfizer COVID vaccine on 1/14 last week at pharmacy. At the time of inoculation, she did not experience any symptoms and went home after the 15 minute waiting period. The next day, she developed a generalized headache that started in her neck and continued over her head. She states that this continued to get worse throughout the day and on Saturday, she woke up and described a constant, 10/10, dull-aching pain that started at her neck/back of head and extended down to her shoulders to the tips of her fingers. She also stated that she had the same pain starting around her groin extending down to her knees and ankles. Patient initially tried taking Tylenol and ibuprofen to treat the pain, and said that those treatments normally work for her osteoarthritis, but that her pain did not improve afterwards. In addition to the pain, she also states that she developed worsening weakness to the point where she could not walk around her home. She stated that she thought moving around and being active had helped her fight through the pain and tolerate it, but that laying down and resting actually seemed to make it worse. With her symptoms worsening and her inability to walk, she decided to come to the hospital to get further treatment. She denied ever having an adverse reaction to other vaccines she has received previously. She receives the flu vaccine every year, and received measles, polio and other childhood vaccinations that she could not recall. She was diagnosed with polymyalgia rheumatica and started on 20mg prednisone daily. She had a remarkable response to the steroids and her symptoms resolved within 24 hours. She was discharged on her 3rd day of admission. On ROS, she denies fevers, chills, night sweats, SOB, changes to vision, eye pain, cough, chest pain, sputum production, nausea, vomiting, diarrhea, dysuria or hematuria. She affirmed weight loss, headache, neck stiffness, dizziness, lightheadedness, muscle stiffness/pain, reduced ROM, and urinary urgency and incontinence.
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| 68 | 2021-01-25 | musculoskeletal stiffness |
Mild to medium headache. Not particularly quick onset, Felt more like tension headache than like mig...
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Mild to medium headache. Not particularly quick onset, Felt more like tension headache than like migraine type. Accompanied by stiff neck/shoulders. Took no medication - headache and stiffness continued into evening at mild level. Home thermometer showed 98.7 around 8:00 pm ( I am usually 96.5 to 97.5 ) No problem sleeping that night and headache and 'fever' was gone upon awakening. Similar symptoms ( no fever) developing late afternoon of 1/26/2021 - will input another report if different outcome.
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| 68 | 2021-01-26 | joint pain |
chills; Sore throat; some aching, like body aches; joint tenderness; some swelling at the injection ...
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chills; Sore throat; some aching, like body aches; joint tenderness; some swelling at the injection site; arm tenderness; This is a spontaneous report from a contactable consumer reported for self. This 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 13:30 on Arm Left at single dose (lot: EK9231, Expiry: 30Apr2021) for covid-19 immunisation. Give her a follow up appointment for a second dose, that will be 02 Feb at 1:20 PM. Medical History included arthritis and had surgery for right knee replacement 6 years ago (2015). They are trying to figure out, she has water in her ear she has had CT scans recently trying to check for any problems that could be corrected surgically and that was all clean. She has had a mammogram, she was not sure about the mammogram yet but she thinks they would have called her if there was a problem with that. Historical vaccine included Just mild stuff with the flu vaccine for immunisation on occasion she has had similar reactions that were very mild with the flu vaccine and last year she had none of that at all. She says when she has had any other vaccine, she had no reaction other than maybe a slightly sore arm. No other products. She did have some mild side effects. She was really glad she got this shot. She said she had experienced some chilling on 13Jan2021, these are all very mild symptoms. She had a sore throat on 13Jan2021, some aching, like body aches on 13Jan2021 and joint tenderness on 13Jan2021. She just got chilled every once in a while. It was not very bad. She said the sore throat had persisted about the same, but the coffee helped. She was having some swelling at the injection site that was about the same as when it began on 13Jan2021. She was having some arm tenderness on 13Jan2021. She did not have any adverse reactions yesterday (12Jan2021) she was so excited to get it. Outcome of the events was not recovered.
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| 68 | 2021-01-26 | back pain, musculoskeletal chest pain |
1/18/21 begin muscle cramp starting at lower rib on rt side 1/19/21 next was deep, severe, debilita...
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1/18/21 begin muscle cramp starting at lower rib on rt side 1/19/21 next was deep, severe, debilitating pain from mid front center to center back at level of last rib on rt Diagnosed w Shingles, no rash or blisters -severe debilitating nerve pain . Valacyclovir 2 grams a day for seven days 1/27/21 no rash or redness ever developed but nerve pain continues, skin still sensitive to touch, less stabbing sharp debilitating pain to now an aching nagging pain from mid center in a semi circle to mid back.
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| 68 | 2021-01-26 | musculoskeletal stiffness |
6 days after vaccine I had fever, nausea, headache, stiff neck, fatigue. Symptoms lasted 2 days and...
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6 days after vaccine I had fever, nausea, headache, stiff neck, fatigue. Symptoms lasted 2 days and are improving.
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| 68 | 2021-01-27 | back pain |
Back pain; tired; whole body trembled; nervous; facial tingling; immediate pain in arm from injectio...
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Back pain; tired; whole body trembled; nervous; facial tingling; immediate pain in arm from injection; couldn't lift her arm at all; left eye twitching; Chills; Nausea; no appetite; whole body ache; This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 11Jan2021 5:15 PM at a single dose on arm for COVID-19 immunization. Medical history included ongoing shellfish allergy from 1975 (she carries epi pen), ongoing iodine allergy from 1975 (she carries epi pen), ongoing Mitral valve prolapse (for 20 years), blood pressure high, and cholesterol. The patient had mitral valve prolapse for about 20 years now. They are just watching it now. She just saw the cardiologist, and had an echo done. If the symptoms worsen, they will proceed. Concomitant medications included diltiazem for blood pressure high and atorvastatin for cholesterol, both from an unspecified date and ongoing; she has been on these medications for 30 years now. On 11Jan2021, the patient experienced facial tingling, immediate pain in arm from injection, couldn't lift her arm at all, left eye twitching, chills, nausea, no appetite, whole body ache, tired, whole body trembled, nervous. On 12Jan2021, the patient experienced back pain. The patient explained that on 11Jan2021, evening at 5:15pm, she received her first COVID 19 vaccine. The Pfizer vaccine was being given out at that time. She has shellfish and iodine allergies. So, they made her sit and wait 30 minutes after being injected. One of her daughters took her. On the drive home, a few minutes after leaving she developed facial tingling. At first, she thought nothing of it. She did have immediate pain in her arm from the injection. By the time she got home, she couldn't lift her arm at all. It was that painful. The next morning, she couldn't lift arm, and if she tried, she would be in pain. Also, her left eye started twitching right away also. That night she really noticed it. It was not a constant twitching. She thought at first it was because she was tired or from the pain in her body. But then she noticed the next day it was still doing that. It was still twitching. It is not constant, but it was here and there. She still had it on 13Jan2021, but so far nothing at the day of report (14Jan2021). She also had chills. She had on double clothes, and coverings on her feet and hands. The chills wouldn't go away. Her whole body trembled. On 13Jan2021, Wednesday morning, they went away. She experienced nausea and no appetite. Her whole body ached. It was so brutal. The problem was with her left eye. It didn't twitch constantly, but it got her nervous. She is pretty sure she is going to refuse the second dose. She has heard that the 2nd part is when most people have the worst side effects. So, she is not comfortable getting it. She also got back pain. It wasn't severe, but it was there. She is against getting the second shot. She stated that she is a medical assistant at a pediatric office. She doesn't have a prescribing doctor. She got it (vaccine) because of her age. She was advised to get it as she was around patients. Work gave them the option. The inability to move her arm ended in the middle of night at 4 am 14Jan 2021. She noticed she could move her arm. Her second dose is scheduled for 01Feb2021 at 8:45 am. She does work in a pediatric office. If the second part of side effects are worse, then she doesn't want to take the chance. The eye has her concerned. Outcome of the events were as follows: facial tingling recovered on 11Jan2021, immediate pain in arm from injection recovered on 13Jan2021, chills recovered on 13Jan2021, nausea recovered on 13Jan2021, no appetite recovered on 13Jan2021, whole body ache recovered on 13Jan2021, couldn't lift her arm at all recovered on 14Jan2021, back pain was recovering, while outcome for events left eye twitching, tired, whole body trembled, and nervous, was unknown. Information about lot/batch number has been requested.
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| 68 | 2021-01-28 | muscle pain |
tiredness; headache; muscle aches; nausea; dizziness; This is a spontaneous report from a contactabl...
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tiredness; headache; muscle aches; nausea; dizziness; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283), via an unspecified route of administration on 11Jan2021 at 11:00 AM at a single dose on the left arm for COVID-19 immunization. Medical history included Barret's esophagus and glaucoma both from an unknown date and unknown if ongoing. Concomitant medication included dorzolamide;timolol maleate (manufacturer unknown) and pantoprazole (manufacturer unknown). The patient did not have COVID-19 prior to vaccination. The patient did not have other vaccines in four weeks. The patient previously took codeine and experienced allergies. The patient experienced tiredness, headache, muscle aches, nausea and dizziness all on 12Jan2021 at 03:30 PM. The patient did not receive any treatment for the events. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
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| 68 | 2021-01-31 | joint pain |
PATIENT REPORTS SEVERE ARM PAIN FROM SITE DOWN INTO WRIST AND FINGERS. PAIN IS SO SEVERE SHECANNOT L...
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PATIENT REPORTS SEVERE ARM PAIN FROM SITE DOWN INTO WRIST AND FINGERS. PAIN IS SO SEVERE SHECANNOT LIFT OR USE A SPATULA TO EVEN TURN EGGS OVER IN FRYING PAN. STARTED ON SUNDAY 1/24/21 3 DAYS AFTER RECEIVING FIRST DOSE OF VACCINE. PAIN MINIMAL AT INJECTION SITE, BUT PAIN ALSO OCCURS IN SHOULDER. UNABLE TO RAISE ARM ABOVE HEAD OR EVEN STRAIGHT OUT. WAS SEEN IN URGENT CARE. PROVIDER REPORTS NO SIGNS OF PROBLEMS AT INJECTION SITE. NO REDNESS, NO SWELLING, NO NECROTIC TISSUE.
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| 68 | 2021-01-31 | back pain, muscular weakness |
About 6 hours after receiving the shot, I began to have severe lower back pain (9 pm). By Midnight...
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About 6 hours after receiving the shot, I began to have severe lower back pain (9 pm). By Midnight, I had excruciating nerve pain shooting across my lower back along with the muscular back pain. I was up all night in pain. I did not take anything for the pain for fear of comprising the vaccine. the next day pain was worse, called my doctor and was told I could take Tramadol, 50 mg. It did nothing for the pain until I took another dose. Pain got worse and I was unable to get myself out of bed, or from a sitting position without my husband pulling me up. My muscles were not working, or it was just too painful, I'm not sure. Could barely walk. This lasted for 3 full days and then the pain gradually started to subside. Took a full week for back pain to totally go away.
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| 68 | 2021-01-31 | musculoskeletal discomfort |
Fatigue; joint discomfort; mild fever; mild headache; This is a spontaneous report from a contactabl...
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Fatigue; joint discomfort; mild fever; mild headache; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via an unspecified route of administration in left arm on 15Jan2021 at 08:30 AM at single dose for COVID-19 immunization. Medical history included CAD (coronary artery disease), mild COPD (chronic obstructive pulmonary disease) and GERD (gastroesophageal reflux disease). Patient had Covid prior vaccination. Patient was not pregnant. Patient has no known allergies. No other vaccines in four weeks. Concomitant medications included rosuvastatin calcium (CRESTOR), carvedilol (COREG) and vitamins (unspecified). On 16Jan2021 at 01:00 PM, the patient experienced fatigue, joint discomfort, mild fever, and mild headache. Patient did not receive treatment for the events. Patient was not tested for Covid post vaccination. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 68 | 2021-02-01 | muscle pain |
Swelling under the left side of left breast; Mild headache; minor muscle pain in left and arms below...
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Swelling under the left side of left breast; Mild headache; minor muscle pain in left and arms below elbow on top of arm; minor soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL-1283 (also reported as "FL-1283"), intramuscular on left arm on 19Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included known allergies to penicillin and dust molds. The patient is not pregnant at the time of vaccination. No other vaccine in four weeks. Concomitant medications included Atorvastatin, ergocalciferol (VIT D), Biotin and Glucosamine with MSM. The patient previously took first dose of BNT162B2 (lot number: EK92316) on 29Dec2020 12:45 intramuscular on left arm for COVID-19 immunization. On 19Jan2021 at 16:45, the patient had swelling under the left side of left breast, mild headache, minor muscle pain in left and arms below elbow on top of arm and minor soreness at injection site. Patient was most concerned about swelling. No treatment for the events. The patient had no COVID prior vaccination and not COVID tested post vaccination. The outcome of the events was not recovered.
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| 68 | 2021-02-02 | muscle pain | hyperesthesia, myalgia, chills, fatigue, headache |
| 68 | 2021-02-03 | muscle pain, joint pain |
Jan. 29 (evening): mild headache, mild chills, pain at injection site Jan. 30 (all day): moderate he...
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Jan. 29 (evening): mild headache, mild chills, pain at injection site Jan. 30 (all day): moderate headache, chills, aching (muscles), fatigue, low-grade fever (100.2), mild nausea, sore upper arm Jan. 31: mild headache, mild muscle/joint ache, chills, fatigue, pain at injection site, loss of appetite Feb. 1: mild pain at injection site Feb. 2: all symptoms resolved
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| 68 | 2021-02-04 | armpit pain |
Patient reported that she received her 2nd COVID vaccine. She reports no symptoms after her first va...
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Patient reported that she received her 2nd COVID vaccine. She reports no symptoms after her first vaccine injection. Both injections were in her left deltoid. On the evening of 2/2/2021, she started having some aching in the left arm. She noticed that her left axillary lymph node is swollen and painful. She states the swelling is very significant and it hurts, not just tender to touch. Doesn't look red or feel warm. No fever. She took ibuprofen 400 mg. Patient advised to follow-up with her PCP.
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| 68 | 2021-02-04 | back pain |
3 hours after the injunction I received a severe low back pain. The pain lasted 2 and a half hours. ...
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3 hours after the injunction I received a severe low back pain. The pain lasted 2 and a half hours. I didn?t take any thing for it. I just went away.
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| 68 | 2021-02-05 | joint pain |
Started with chills fever. Had flu like symptoms,joint pain headaches fatigue achy Just SICK all ove...
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Started with chills fever. Had flu like symptoms,joint pain headaches fatigue achy Just SICK all over. Nasal congestion.
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| 68 | 2021-02-05 | bone pain |
Early morning after vaccine started with headache then nausea and chilling. Chilling all day and ev...
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Early morning after vaccine started with headache then nausea and chilling. Chilling all day and evening Fever must have broke about 24 hours or so after with breaking out in a sweat. Symptoms just keep getting worse as the day progressed . Almost 24 hours after the bones just hurt. Today, 2/6/21, two days after vaccination still have nagging headache
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| 68 | 2021-02-06 | muscle pain |
After 72 hrs extreme sore throat/ fever as high as 102.8 , muscle aches , chills and sweating still ...
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After 72 hrs extreme sore throat/ fever as high as 102.8 , muscle aches , chills and sweating still continuing after 3 days . Called on call doctor and she put me on zpac antibiotics 7pm Feb 6 . With Tylenol and ibuprofen able to get temperature down to 100.1 but goes back up in evening, 102 temp . I feel a little better this morning, temp . 99.8 , still extreme sour throat. On call doctor told me if systems get worse to go to immediate care
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| 68 | 2021-02-07 | joint pain, muscle pain |
joint pain; dizzy; face a little swollen; splotches on both cheeks; burned; Feeling sick; Injection ...
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joint pain; dizzy; face a little swollen; splotches on both cheeks; burned; Feeling sick; Injection site pain; Headache; Muscle pain; tired; This is a spontaneous report from a contactable consumer reporting for herself. A 68-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration in the left arm, on 13Jan2021 14:30 at single dose for Covid-19 immunisation . Medical history included cyclic neutropenia from 1998, thyroid disorder from 2001. There were no concomitant medications. The patient experienced feeling sick on 13Jan2021 with outcome of recovering , injection site pain on 13Jan2021 with outcome of recovering , headache on 13Jan2021 with outcome of recovering , muscle pain on 13Jan2021 with outcome of recovering , tired on 13Jan2021 with outcome of recovering , splotches on both cheeks on 14Jan2021 with outcome of recovering , dizzy on 16Jan2021 with outcome of recovering , face a little swollen on 16Jan2021 with outcome of recovering , joint pain on an unspecified date with outcome of recovering , burned on 13Jan2021 with outcome of recovering. The patient received ibuprofen 400 mg to treat headache, muscle pain, joint pain. The patient is not sure if LOT number is EL1283 or EC1283. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 68 | 2021-02-07 | joint pain |
pain down left arm to wrist and hand (still there); pain down left arm to wrist and hand (still ther...
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pain down left arm to wrist and hand (still there); pain down left arm to wrist and hand (still there); unable to open & close left hand until next morning; Headache; occasional chills; fever; fatigue; Mild facial swelling; This is a spontaneous report from a contactable consumer (patient) reported that a 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9263; expiry date: unknown) via an unspecified route of administration in the left arm, on 21Jan2021 at 14:00, at a single dose, for COVID-19 immunization. Medical history included allergies to Sulfa. The patient did not have other chronic health conditions. Concomitant medications included turmeric [curcuma longa rhizome], and ashwagandha. The patient previously took doxycycline and experienced allergies. On 21Jan2021, the patient had mild facial swelling 20 minutes after inoculation, at 14:30 the patient had pain down left arm to wrist and hand (still there), unable to open and close left hand until next morning, headache, occasional chills, fever and fatigue. The patient did not receive treatment for the events. The events were considered non-serious. The patient was recovering from the events.
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| 68 | 2021-02-08 | groin pain |
It has now been 8 days since my first dose of Pzifer vaccine (February 1, 2021) and I have been exp...
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It has now been 8 days since my first dose of Pzifer vaccine (February 1, 2021) and I have been experiencing painful, aching quads in both legs and groin area. Have taken Advil to relieve pain and still feel intense throbing legs and especially the R groin area. On a scale of 1-10 it is a 7-8. Ten years ago I was diagonosed with Osetomyletics and the blood infection landed on my pelvic area and I was unable to walk . Spent a week in the hospital and infectious disease doctors put a port in my chest an for 1 month was on heavy duty antibotics to rid the infection. I am experiencing the pain in the same area of the groin, but now the quad muscles are equally painfully. I am concerned as it has now been 8 days and there is NO relief to my pain and I am assuming it is a side effect of the vaccine? Please adivse.
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| 68 | 2021-02-08 | muscular weakness |
My arm was sore pretty much from the beginning and is still sore today, February 9th. It's not terri...
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My arm was sore pretty much from the beginning and is still sore today, February 9th. It's not terribly painful but uncomfortable, and I have lost strength in this arm.
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| 68 | 2021-02-08 | musculoskeletal stiffness |
suspect polymyalgia rheumatica; bilateral proximal muscle stiffness; weakness/ could not support her...
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suspect polymyalgia rheumatica; bilateral proximal muscle stiffness; weakness/ could not support herself to walk around in her home; pain in her upper and lower extremities/ this bilateral upper and lower extremity pain; stiffness and weakness beginning at the shoulders and hips; dull headache; This is a spontaneous report from a contactable healthcare professional. A 68-year-old female (not pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 14Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), COPD (chronic obstructive pulmonary disease), previous TIA (Transient ischemic attack) with some residual right sided weakness, CHF (congestive heart failure), osteoarthritis. Had a childhood vaccination history. No Known allergies. Concomitant medications included albuterol, aspirin, atorvastatin, fluticasone, furosemide, hydralazine, ibuprofen, lisinopril, metoprolol, multivitamin, all above were in two weeks (as of 25Jan2021). The patient previously received influenza vaccine yearly, and received her pneumonia vaccines over the last several years, both for immunization and never had a reaction to a vaccine. The patient was not pregnant at time of vaccination. No other vaccine received in four weeks. The patient developed a dull headache on 15Jan2021, one date after the vaccine, but that it resolved after 24 hours on 16Jan2021. On 16Jan2021 at 8:00 AM, the patient developed bilateral proximal muscle stiffness, weakness, and pain in her upper and lower extremities over the course of 1 week. The patient started experiencing this bilateral upper and lower extremity pain, stiffness and weakness beginning at the shoulders and hips and extending distally over several days. Her symptoms started out relatively mild and progressively got worse over the course of 7 days. She presented to the reporting healthcare professional 8 days after her vaccination and she was extremely weak and could not support herself to walk around in her home, the reporting healthcare professional suspect polymyalgia rheumatica. All the events (except dull headache) resulted in emergency room/department or urgent care, hospitalization. The patient was hospitalization due to all the above events for 3 days. The patient had a remarkable response to the treatment of prednisone during her hospitalization. It was unknown if covid prior vaccination. The patient underwent lab tests and procedures, which included COVID tested (COVID test type: Nasal Swab, SARS-COVID19 PCR) post vaccination on 23Jan2021: Negative. Outcome of event headache was recovered on 16Jan2021 and all the events was recovered on an unspecified date. Information about lot/batch number was requested; Sender's Comments: A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events cannot be excluded, considering the temporal relationship. However, it is worth noting that the 68-year-old female patient had pre-existing osteoarthritis, which could be one of the causes of joint symptoms. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-02-08 | neck pain |
Left arm itching, swollen and skin on entire left arm was red and across shoulder to neck. Neck pain...
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Left arm itching, swollen and skin on entire left arm was red and across shoulder to neck. Neck pain and headache. Early evening I developed hoarseness and trouble breathing. Went to Emergency room. They administered IVwith Benedryl; Prednisone; and Pepcid. After an hour my breathing was better and some of the redness on arm was better. I went to physician on 2/5/2021 because of neck pain and was prescribed MethylPrednisolone Tablets, 4 MG. 6 day pack and was on day 3 when the symptoms started.
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| 68 | 2021-02-09 | joint pain |
The heat from the elbow (not clarified further), besides the knees and the ankle and the toes.; pain...
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The heat from the elbow (not clarified further), besides the knees and the ankle and the toes.; pain in knees, ankles and feet and lower leg with the cramping and tingling, mostly tingling and burning like a radiating pain; discomfort with burning , tingling and radiating sensations in both knees , lower legs and feet during the night , those sensations have returned 10 days after vaccine; discomfort with burning , tingling and radiating sensations in both knees , lower legs and feet during the night , those sensations have returned 10 days after vaccine; I experienced discomfort with burning , tingling and radiating sensations in both knees , lower legs and feet during the night , those sensations have returned 10 days after vaccine; Also occasionally pain in hips, elbows and other joints/Pricking pain in my left hip/mild burning radiating from around the joints; cramping in my left footmy knees, my ankles and my feet, the lower leg felt cramp; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose bnt162b2 (BNT162B2, lot number: EL1283), via an unspecified route of administration, at arm left, on 12Jan2021 15:00 at single dose for COVID-19 immunisation. Medical history included blood cholesterol increased, chronic productive cough, known allergies to sulfa, sinus disorder. Is pregnant: No. Concomitant medication included mometasone furoate (FLONASE) for sinus, ascorbic acid (VITAMIN C). No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination. 4 days after receiving vaccine, on 16Jan2021 12:00 AM the patient experienced discomfort with burning, tingling and radiating sensations in both knees , lower legs and feet during the night , those sensations have returned 10 days after vaccine and have continued for more than 30 hours now , Also occasionally pain in hips, elbows and other joints. As of 23Jan2021, it was reported the patient experienced burning, tingling sensations around ankles, knees and lower leg. Yesterday started feeling same thing, the feet, toes, around ankles, up legs and around knees. Sometime it feels like it's a mild burning radiating from around the joints and in the lower leg too. It is mainly her feet up to above the knees, burning, tingling, radiating. Sometimes have occasional pain little bit in some of the other joints, this is a little bit more than joint pain. Consumer stated, that she received the first dose of this Pfizer Vaccine on 12Jan2021. And about four days after during the night she was feeling some kind of burning, tingling sensations around ankles and knees and lower leg. It went away it lasted maybe about 4 hours, but then yesterday which is on the 22nd started in early afternoon started feeling the same thing, the feet and the toes, around ankles, up the legs and around the knees. Sometime it feels like it's a mild burning radiating from you know around the joints and in the lower leg too. It is mainly feet up to above the knees, burning, tingling, radiating. And sometimes I have occasional pain in just a little bit in some of the other joints you know that's been going on after the vaccine occasionally. The heat from the elbow (not clarified further), besides the knees and the ankle and the toes. The patient called this number because that is the number that was on the page to say if there was anything to report and then you know she was wondering if this is, she saw that some of the side effects could be joint pain but this is a little bit more than joint pain. So, she was wondering if there is anything. She mean she was going to see doctor on Monday, this has been going on for more than 30 hours now, but she was wondering if there is any advice in this. Pricking pain in her left hip started on 12Jan2021, Little bit of cramping in left foot started on 12Jan2021, Knees, ankles and feet, the lower leg felt cramp, like a radiating pain started on 16Jan2021. Consumer stated, initially, when she just got the vaccine, she felt a little prick in her left hip, like a little pain but it did not stay, pricking pain in her left hip. A little bit of cramping in her left foot, but it went away. So she did not think anything of it. 4 days later, on the 16Jan2021 (later confirmed), during the night her knees, her ankles and feet, the lower leg felt cramp, like a radiating pain. It was not very severe, like a mild pain in the knees and the lower legs and feet, a type of tingling but it went away. Pain was like a radiating, sort of burning but it was mild burn. Date when started experiencing pain is on the same day, 12Jan2021. Lab work was no. Treatment was no, because it was transient but afterwards what concerned her is on Friday which is the 22nd, she started experiencing a pain in knees, ankles and feet and lower leg with the cramping and tingling, mostly tingling and burning like a radiating pain. The whole, above her knees, down the lower leg, ankles, feet and toes and it continued up till last night and so more than for 30 hours that is what concerned her. That is why she called last night. The outcome of the event feeling hot , pain in extremity, muscle spasm was unknown, of the other events was not recovered.
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| 68 | 2021-02-09 | muscle pain, joint pain |
1..5 hrs after shit. Right arm red, rash, itching. Hives from shot up onto right side of neck, right...
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1..5 hrs after shit. Right arm red, rash, itching. Hives from shot up onto right side of neck, right side of face, into hair on right side. R side of face swollen, numb and droopy. About 5 hrs after started having severe stomach cramps, nausea, bad headache, achy, joints hurt. This lasted fir two days. For another 10 days have felt sore joints and muscles, Headache, rash, fatigued, face still slightly swollen, numb and droopy. Symptoms were less after 2days but still there.
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| 68 | 2021-02-10 | muscle pain |
arm soreness; community acquired pneumonia; COPD; shortness of breath; chest congestion; weakness; f...
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arm soreness; community acquired pneumonia; COPD; shortness of breath; chest congestion; weakness; fatigue; Muscle aches and pains; she became ill; This is a spontaneous report from a contactable nurse from a Pfizer-sponsored program Pfizer First Connect. A 68-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on 06Jan2021 at single dose on right deltoid for covid-19 immunisation. Medical history included blood pressure high and seasonal allergies. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 16Dec2020 for COVID-19 immunization. The patient experienced community acquired pneumonia, shortness of breath, chest congestion, weakness, fatigue, COPD, muscle aches and pains, she became ill, all on12Jan2021; arm soreness on an unspecified date. Events required Emergency Room visit. Clinical course reported as: she got the second dose of the pfizer covid vaccine on 06Jan2021 and on 12Jan2021 she experienced shortness of breath, chest congestion, weakness and fatigue. Nurse stated ER doctor thought she had COPD or community acquired pneumonia. Nurse further stated she had the second COVID-19 vaccine on 06Jan2021. A week later on 12Jan2021, she became ill. She had all the symptoms of COVID. She was short of breath, very fatigued. She couldn't get any air, she was at work. She had muscle aches and pains. The shortness of breath, fatigue and weakness lasted several days. She also had severe chest congestion. She confirmed she got better. It actually took 4 or 5 days. By that Sunday (17Jan2021) she was better. She wanted it noted she had no reaction right after the shot. She stated she only had arm soreness, it was just a little sore, not even worth mentioning. It was only when she moved her arm a certain way. This was with either vaccine (first or second vaccine). She went to the doctor and somebody thought it might be a reaction, but the nurse thought it was too late for a reaction. The ER doctor thought it was COPD and community acquired pneumonia. Her primary doctor thought it was COPD. The patient underwent lab tests and procedures which included COVID-19 test: negative on 12Jan2021. Outcome of arm soreness was unknown, others was recovering.; Sender's Comments: Based on the drug-event time interval and the vaccine's safety profile, the community acquired pneumonia is possibly intercurrent condition, unrelated to vaccine BNT162B2 administration, which is not the disease that the vaccine BNT162B2 can prevent from. While the COPD is more likely underlying condition, unrelated to vaccine BNT162 injection. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-02-10 | muscle pain |
6 hours after 2nd shot ran 202 degree fever, had head ache, muscle aches, chills, sweats, and fatigu...
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6 hours after 2nd shot ran 202 degree fever, had head ache, muscle aches, chills, sweats, and fatigue for well over 48 hours.
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| 68 | 2021-02-11 | joint pain |
On the night of the vaccine my left arm was just slightly sore and I had a headache. I took 2 advil...
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On the night of the vaccine my left arm was just slightly sore and I had a headache. I took 2 advil before bed and woke up the next morning fine. The real reaction came almost a week to the day later on Monday, Feb. 8 in them morning I noticed that my shoulder joint on my left arm was very sore and all of the lymph nodes from my shoulder to my elbow on just my left arm were very achey. This came and went off and on all that day. I did not take anything for it because I wanted to see how long it lasted. By the next morning it was entirely gone and has remained gone and I feel just fine.
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| 68 | 2021-02-11 | joint pain |
increase in blood pressure..156/96 for at least 6-8 hrs. ..blood pressure has not been elevated in 2...
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increase in blood pressure..156/96 for at least 6-8 hrs. ..blood pressure has not been elevated in 2-3 years. I took my prescribed blood pressure medication prior to bed time. This morning b/p is in normal range. other side effects: sore arm, leg and hip pain. This am has improved.
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| 68 | 2021-02-14 | joint pain | infection site pain, tiredness, headache, chills, joint pain, fever, foggy thinking, feeling unwell |
| 68 | 2021-02-15 | armpit pain | Painful swelling lymph nodes in armpit of injected arm |
| 68 | 2021-02-15 | muscle pain |
After both doses had soreness around injection site on arm, lasting 3 days. After dose 1, 5 days aft...
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After both doses had soreness around injection site on arm, lasting 3 days. After dose 1, 5 days after I had itching, prickly tingly sensations everywhere, especially arms, legs, neck, and back. These lasted for 11 days after that, finally subsided. But then I got dose 2, and had sore arm, and next day, aches in muscles, low fever, congestion but all mild. Took ibuprofen and went away after 24 hours. 5 days later, the itching, tingling started up again and was more intense and everywhere. Have had some redness, swelling, red bumps in itchy areas, they come and go. Worse when I have hot flash. Itching is keeping me awake along with anxiety and restlessness. Hope this won't last for another 10 days, very uncomfortable.
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| 68 | 2021-02-16 | back pain, neck pain |
out like a 'light' and this stuff knock her out; whole entire face her head, down her back her neck ...
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out like a 'light' and this stuff knock her out; whole entire face her head, down her back her neck was numb/Numbness in leg/jaws are numb; I'm feeling my teeth are still and my jaws are numb; felt very odd sensation as she was swallowing; was closing up but much wasn't closing up/it was not full open; swelling on her throat; Muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side; it hurts my neck area across my back; it hurts my neck area across my back; Stumbling; face was swollen; eyes looks like little switch; thirsty; felt very sluggish; nose started to running; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first single dose BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (anatomical location: arm left) on 29Jan2021 15:00 for COVID-19 immunization. Medical history included insomnia and asthma. The patient's concomitant medications were not reported. Patient stated, "I got the vaccine yesterday about 3 pm and I came home and I had dinner and sat down to watch TV at 9 O' clock, I turn the program on and I was out like a 'light' and this stuff knock me out (onset date: 29Jan2021). My dog has to wake me up licking my face at 3:15 this morning. I normally don't sleep long 4 hours and that's it. I'm 68 years old and I have insomnia (History) but when I woke up I was stumbling around, still have to sleep (onset date Jan2021), I took the dog out to walk and came back and saw myself in mirror, my face was swollen and my eyes looks like little switch. I noticed, I was thirsty and I went to get and drank, some coke because I felt very sluggish and I drank some coke and when I was swallowing the coke I felt very odd sensation as I was swallowing, I noticed that after swallowing. I have asthma (History) to begin with so I'm anticipated on having some of the symptoms it start showing up a bit, my nose started to running and I noticed that my whole entire face my head, down my back my neck was numb along with swelling on my throat, I felt okay but I felt it wasn't being, it was closing up but much wasn't closing up you know what I mean it was not full open. I also had muscle pain in my left arm where they gave me injection and it hurts my neck area across my back down my arms specially my left side. I also noticed I went to a lovely person and when I went to bathroom I pull my pants down I felt numbness on my legs. So, my whole body was kind of having that not tingling sensation but numb and when I ran my fingers across my leg you know how you feel numbness when you run your fingers across a part of your body when it's numb that's exactly how I felt and that was about 3:30 this morning that happened I woke up by but I also want to ask question because I got to go back to my second shot. I'm wondering if I go back to my second dose am I going to have even more intense reaction to the stuff that I get this time." Patient further added "I was still trying to eat something but I'm feeling my teeth are still and my jaws are numb and this I got since yesterday (29Jan2021)." The outcome of events was unknown. Information on the lot/batch number has been requested.
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| 68 | 2021-02-16 | muscle pain, back pain, muscular weakness |
lower back pain; nerve pain; excruciating pain/getting pain; muscle pain; couldn't sleep with the pa...
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lower back pain; nerve pain; excruciating pain/getting pain; muscle pain; couldn't sleep with the pain; Her husband had to pull her out of the bed because she felt she had no muscle activity; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #: EL8982), via an unspecified route of administration in the left arm on 17Jan2021 at 15:00 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. Medical history included benign spinal cord tumor from 1987 and unspecified if ongoing (a lot of bone had to get cut), lot of scar tissue (wonders if it is a weak spot) from an unspecified date and unspecified if ongoing, thyroid removed in 2015, neurosurgery (to remove the benign spinal cord tumor) on an unspecified date, thyroid on an unspecified date and unspecified if ongoing and cholesterol from an unspecified date and unspecified if ongoing. Concomitant medications included ongoing levothyroxine (strength: 125 ug) taken for an unspecified indication at 125 ug, 1x/day, ongoing pravastatin (strength: 40mg) taken for cholesterol from an unspecified date at 40mg, 1x/day and ongoing multivitamin. The patient did not receive any other vaccinations within four weeks prior to the first administration of the COVID-19 vaccine. The patient experienced lower back pain, nerve pain, excruciating pain/getting pain, muscle pain, couldn't sleep with the pain and her husband had to pull her out of the bed because she felt she had no muscle activity, all on 17Jan2021. The patient called and stated "she had a very extreme reaction from the first dose of the vaccine, which she had last Sunday the 17th. It began with lower back pain, which did not alarm her too much but then it went in to nerve pain. By the end of the evening, by about midnight, she was in what she considered to be excruciating pain. She changed positions and it was hitting the nerve and she was getting pain and having muscle pain. She was up all night because she could not sleep with the pain. Monday and Tuesday were very excruciating, and she took Tramadol Monday after consulting with her doctor. She did not get any relief until Wednesday, 3 days after the shot. Even today she had some lower back pain, but it is way better than it was. It was improving from Wednesday to today but Sunday to Wednesday was excruciating since it was giving her nerve pain. Her husband had to pull her out of the bed because she felt she had no muscle activity. In 1987 she had a spinal cord tumor and a lot of bone had to get cut and she stated she was sure she had a lot of scar tissue and wondered if it was a weak spot. She stated this could be an isolated incident, but she really thought she had another tumor at first until it started dissipating on its own. She stated she did not know anyone who has had this reaction and asked if it was safe/advisable to get the second shot? She stated she was afraid of the permanent nerve damage but as long as it cannot do anything permanent, she wanted to get it. Was this a reported symptom? Has anyone ever gotten paralyzed? After verbal response she stated she will talk with her doctor and maybe see a neurologist." Upon follow-up the patient called and stated "I had two questions actually. I received the Pfizer Vaccine yesterday and last night I started with the excruciating back pain, my lower back. I do not know if it was coincidence or not because I have back trouble before. I did not do anything to throw my back out. However, I was told it would be okay to take Extra Strength Tylenol. I took 4 Tylenol within like 3 hours period because it was not working. I took another two this morning. Tylenol was not doing anything at all for the pain relief. My question was, I have a prescription of Tramadol which I took for pain for different reason, but I have it. First of all, I hope by taking the Tylenol yesterday that it did not interfere with the efficiency of the vaccine. My other question is can I take the Tramadol now? Since the vaccine was 24 hours ago would it interfere with efficiency?" Upon follow-up the patient called to report that "she went to her chiropractor late Wednesday afternoon, and he did some stretching, but her spine was not out of alignment, so he felt her pain was due to the vaccine. Stated that it was not until her back started getting better on Wednesday without treatment that she first started to attribute it to the vaccine, because her back just did not get better on its own. Stated that the first day she did not take anything for the pain because she was worried that it might interact with the vaccine or its effectiveness, but the next day she began taking Tramadol pain meds that she already had in the house for her knee. Stated that the pain in her back was so bad, that even a strong medication like the Tramadol did not take away the pain. It did not help all that much, she had to take a 2nd 50mg tablet 3 hours later. Should she get the second dose of the vaccine? Could it possibly do more nerve damage; could she be jeopardizing her nervous system? Have there been any other reports about this? Stated that other people had minor things like, one person reported being tired for a couple days, and another person reported body aches like with the flu, but after 3 days they both were fine. Her husband was 74 and had the vaccine and he had no side effects." The events prompted a visit to her physician. The patient stated that "this was the first day since Sunday that she was feeling almost 100%. She had the pain from Sunday evening all the way until noon on Wednesday; at that point it improved about 50% and she had some mobility." The outcomes of the events lower back pain, nerve pain, excruciating pain/getting pain, muscle pain, couldn't sleep with the pain and her husband had to pull her out of the bed because she felt she had no muscle activity were all recovering/resolving.
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| 68 | 2021-02-17 | joint pain |
Joint pain; had liquid diarrhea; Stomach not crampy but urgency when it happens; Medical history inc...
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Joint pain; had liquid diarrhea; Stomach not crampy but urgency when it happens; Medical history include coeliac disease; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 23Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included essential tremor, coeliac disease, high blood pressure, and allergies to wheat and dairy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included enalapril (ENALAPRIL), venlafaxine hydrochloride (EFFEXOR), propranolol and hydrochlorothiazide (HCT). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported for about a week, she has had liquid diarrhea. The patient also has joint pain, stomach not crampy but urgency when it happens and no fever. The patient did not received treatment for the adverse events and the event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The onset of the events was on 26Jan2021 and the outcome of the events was not recovered.
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| 68 | 2021-02-17 | joint pain |
5 days after vaccination toothache on left side of mouth, 9 days after vaccination left elbow achy, ...
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5 days after vaccination toothache on left side of mouth, 9 days after vaccination left elbow achy, 10 days after vaccination all joints on left side of body achy, joints on right side of body achy to a lesser degree. 11 days after vaccincation all joints in body very achy felt like body was under attacke. 12 Days after vaccination achiness began to subside. 18 days after vaccination achiness continues to be present. I had not experienced joint achiness prior to receiving the vaccine.
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| 68 | 2021-02-17 | groin pain |
Pain in groin area within one hour of receiving vaccine. Felt bloated, pressure in groin area. Was ...
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Pain in groin area within one hour of receiving vaccine. Felt bloated, pressure in groin area. Was difficult to walk due to pain. Lasted 4 days until Monday, Feb.15, 2021, when it eased.
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| 68 | 2021-02-17 | muscle pain |
This is a spontaneous report from a contactable consumer reported for herself. This 68-year-old fema...
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This is a spontaneous report from a contactable consumer reported for herself. This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number EL9265), via an unspecified route of administration at single dose in the left arm on 31Jan2021 11:30 for covid-19 immunisation. Medical history included liver disorder, kidney disease, asthma, allergies to PCN, Sulpr, Iodine dye, pineapple, spinach. Concomitant medications were not reported. On 01Feb2021, the patient experienced achy, fever, chills and neck muscle sorenesswith. No treatment required. The outcome of the events was recovered on an unspecified date in Feb2021. The vaccine was administered at Health Clinc and facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient had not been diagnosed with COVID-19 prior the vaccination.
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| 68 | 2021-02-17 | neck pain |
Red facial rash, facial flushing, feeling hot, mild dizziness, ringing in both ears, left side facia...
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Red facial rash, facial flushing, feeling hot, mild dizziness, ringing in both ears, left side facial and tongue numbness and tingling, left arm and hand numbness and tingling, mild to moderate head and neck ache (meloxicam only took edge off), legs tingling, left arm soreness 5 days, extremely tired, took 2 hour nap after vaccine, slept 10 hours each of two nights following vaccine, upset stomach and diarrhea and yellow stool for two days after vaccine. Most side effects resolved by day 4 with arm pain resolving by day 6.
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| 68 | 2021-02-18 | joint pain |
Feb 5, 2021 at 8:45 started coughing as if having an allergic reaction to a cat. We stopped and g...
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Feb 5, 2021 at 8:45 started coughing as if having an allergic reaction to a cat. We stopped and got me some Claritin, cough drops, and water. Called my PCP and left message. Coughed an asthmatic cough Friday, Saturday, Sunday and Monday. On Monday, Feb. 8 called PCP again. We had a virtual visit. He said, it was not an allergic reaction. He prescribed Prednisone and Alburetol inhaler. On Thursday Feb . 11 I got a rash all over my body that came and went and I got Hives on the palms of my hands. Virtual visit with my PCP. He said that he retracted his statement from Monday and evidently I was having a reaction to the Vaccine. I kept taking the Steroid which I finished on Monday. The rash and hives bothered me till Monday. Tuesday and Wednesday rash and hives gone. On Thursday morning I woke up with a burning pain across my left side of my chest to the backside and pain on my knees. On Friday the pain was also on the backside of my waist. It felt like shingles. Went to see the NP at Dr. office. They don't think I have shingles. This is all still a reaction to the vaccine.
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| 68 | 2021-02-19 | joint pain |
2 days after the vaccine, I started having severe pain in my knees down my legs. I'm on day 17 and i...
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2 days after the vaccine, I started having severe pain in my knees down my legs. I'm on day 17 and it is at times unbearable. My knees don't want to bend. I can't take an anti-inflammatory because I'm on a blood thinner. So far just taking Tramadol and Tylenol Arthritis. Doesn't touch the pain. Still working with doctor to figure out what to do next.
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| 68 | 2021-02-20 | joint pain, muscle pain | Headache, sore arm, joint and muscle aches, fatigue, ill feeling for a day |
| 68 | 2021-02-21 | musculoskeletal stiffness |
injection site pain, body ache , headache, stiff neck, dizziness, chills, swollen lymph glands in un...
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injection site pain, body ache , headache, stiff neck, dizziness, chills, swollen lymph glands in underarm area. acetaminophen 1000mg every 8 hours was effective for pain relief . bed rest
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| 68 | 2021-02-21 | neck pain |
That evening, 2/17/21, I got home ate some soup in bed soon after, slept 10 hours! The next morning...
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That evening, 2/17/21, I got home ate some soup in bed soon after, slept 10 hours! The next morning went to work and then around 9:30 the chills started, checked my temp 99.8 decided to take myself home, at took temp again, 101.7 then an hour later 102.7 where it remained for the rest of 2/18/21. By the next morning no more chills and temp 97.6. I do have a lingering headache on both sides of my head which meanders down my neck. The site of the injection is still sore and seems to have moved 3 inches down my arm. And there is also a lingering phlegm problem building up at the back of my throat.
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| 68 | 2021-02-22 | muscle pain |
I got the shot at 10:30am. My arm was mildly painful at the injection sight. During the next early ...
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I got the shot at 10:30am. My arm was mildly painful at the injection sight. During the next early morning (~2:00am Friday, Feb 19) I had the chills for about 2 hours. I had intermittent muscle pain, nausea, and fatigue. These symptoms resolved during the day Friday, February 19th.
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| 68 | 2021-02-24 | joint pain | Body aches joint pain, sweats, fever |
| 68 | 2021-02-24 | muscle pain, joint pain |
Symptoms: chills, joint pain, severe headache with blurry vision, injection site soreness, muscle pa...
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Symptoms: chills, joint pain, severe headache with blurry vision, injection site soreness, muscle pain, feeling unwell - very sick, fatigue. I woke up 2/23/2021, Tuesday, with injection site tenderness upper left arm. Tuesday midday the headache began. By evening, I had chills, pronounced joint and muscle soreness, with further progression of headache to severe with vision changes, and a general malaise and feeling very ill. Like having the flu without fever or congestion. I did not seek medical treatment. Symptoms were treated with over the counter medicines and perscriptions medicines on hand, plus bedrest.
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| 68 | 2021-02-25 | joint pain |
high fever, swollen face, rash in face, headache, nausea, swollen lymph nodes, joint pain, chills, w...
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high fever, swollen face, rash in face, headache, nausea, swollen lymph nodes, joint pain, chills, weakness, overall feeling not well.
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| 68 | 2021-02-25 | joint pain |
3 days after the vaccination I woke up with pain around 7 joints (2 hips 2 shoulders 2 knees and 1ri...
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3 days after the vaccination I woke up with pain around 7 joints (2 hips 2 shoulders 2 knees and 1right wrist)Right shoulder the worst pain....i was vaccinate in left shoulder. It is now about 3 weeks later and there is no change. I was prescribed a burst of prednisone 333,22,11 20 mg. It felt good while taking but returned when done. As of today there is no sign of improvement and I am seeking advise about shot #2 which is scheduled for March 2. (in 4 days)
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| 68 | 2021-02-25 | neck pain |
lumps in back of neck, they hurt; lumps in back of neck, they hurt; pain goes around into jaw, up in...
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lumps in back of neck, they hurt; lumps in back of neck, they hurt; pain goes around into jaw, up into the face; pain goes around into jaw, up into the face; ear hurts; felt dizzy; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 23Jan2021 at a single dose for covid-19 immunization. Medical history included high blood pressure (Diagnosed 3 to 4 years ago) and thyroid disorder. There were no concomitant medications. It was reported that the patient got the vaccine on Saturday and went home and fell asleep, woke up and had lumps in back of neck, they hurt, pain goes around into jaw, up into the face and ear hurts. The patient just tried a hot compress, a hot cloth on there, it seemed to help a little bit for a while. Took some Advil and that helped a little bit, but when it wears off it comes back. Adds she felt dizzy too, and still felt like that too, it started right after she got it, and it comes and goes. The outcome of the event dizzy was unknown while not recovered for the remaining events. Information about lot/batch number has been requested.
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| 68 | 2021-02-26 | muscle pain, joint pain |
Severe & debilitating chills, headache, muscle and joint pain 16 hours after injection and lasting a...
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Severe & debilitating chills, headache, muscle and joint pain 16 hours after injection and lasting approximately 8 hours before tapering down to moderate pain level approx 30 hours following injection.
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| 68 | 2021-02-27 | bone pain, muscle pain |
Night sweats, chills horrible muscle bone aches diahrrea, no appetite, had to crawl to the bathroom ...
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Night sweats, chills horrible muscle bone aches diahrrea, no appetite, had to crawl to the bathroom the last 3 days on hands and knees. Lethargic . Tired. Fatigue. 4 days now. And I am getting worse. Heaviness on chest
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| 68 | 2021-02-27 | muscle pain, joint pain |
First shot only chills and mild muscle aches gone by the next morning. Second shot aftereffects wer...
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First shot only chills and mild muscle aches gone by the next morning. Second shot aftereffects were very different. Received the shot around noon on Tuesday , February 23, 2021. Later in the afternoon experienced muscle aches and chills. My head felt kind of weird. Hard to describe except I once had a morphine shot that made me feel close. I spent the next ~60 hours in bed. Fever, severe joint and muscle pain, migraine like headache, and brain fog is about all I remember. It could have been 2 hours or 60 hours, I don't remember. On Wednesday and Thursday my sedentary heart rate was 101 and 95 according to my Apple watch up from 77 on Tuesday. Couldn?t eat. Food tasted and smelled differently but not in a good way. Woke up this morning,Friday, with a mild headache and very fatigued but mostly back to normal.
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| 68 | 2021-03-01 | joint pain |
My heart rate and b/p increased evening after injection. My heart rate and b/p have been maintaine...
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My heart rate and b/p increased evening after injection. My heart rate and b/p have been maintained at normal ranges for years! B/P usually 122/76 and heart rate 76-80. Since I got that vaccine, each evening my heart rate has been 97, 87, 94, 90. B/P 133/85, 145/84. I had flu-like symptoms, headache, injection site pain and joint pain. They subsided.
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| 68 | 2021-03-01 | muscle pain |
Starting the first day I had muscle aches, swollen glands, headache, tiredness and chills, this la...
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Starting the first day I had muscle aches, swollen glands, headache, tiredness and chills, this lasted for three days. Then I did feel better for a few days but had some tiredness. Then Sunday the 28th my body seemed over whelmed with sweats and chills, I developed a rash in my groin area and realized that I had a yeast infection that was affecting my vaginal area, groin, and mouth. I have been treating this with a natural yeast complex and Monistat. I am starting to do better today but felt that I needed to report it to see if others were having the same problem. I feel that the injection adversely affected my body's normal hemostasis and the yeast was the results. I am not looking forward to getting the next shot. I think I did have Covid 19 in late January or early February before it was widely known and there were no tests. I will keep treating myself with natural remedies as chemicals will just inflame the yeast at this time. This is not life threatening but wanted to report the abnormal reaction I have experienced.
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| 68 | 2021-03-01 | muscle pain |
More of an administration error.. It was given by a distracted national guardsman who was waving a...
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More of an administration error.. It was given by a distracted national guardsman who was waving around syringe and talking to someone else as he grabbed my arm---I saw him expel a sizable amt of vaccine from the TB syringe before administering (I'm a retired NP) so was concerned that I had gotten a suboptimal dose---really have no idea how much I got and didnt point out his error b/c I was pretty sure they wouldnt draw up another dose for me . Anyway--just reporting this b/c I was asked to and am hoping for the best! I did have a sore arm, muscle aches and chills so I know that I got some.
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| 68 | 2021-03-02 | back pain, musculoskeletal stiffness, joint pain |
Intense pain in lower back and right hip and pain down my legs (all weak and vulnerable areas where ...
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Intense pain in lower back and right hip and pain down my legs (all weak and vulnerable areas where I have issues now and then). It is bothersome to the point that I cannot find a comfortable position to relieve the pain. It feels like my lower body is being seized up, so to speak. The only way I can sleep is to take 2 Aleeve PM tablets. I take regular Aleeve throughout the day to take the edge off the pain. The reason I suspect it is a side effect is that a year ago I took the new Shingles 2-dose vaccination. I had this same reaction after taking the first dose - and it occurred about 2 weeks after that shot.
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| 68 | 2021-03-02 | muscular weakness |
3- 4 minutes after injection I had tingling in my lips and a strange numb sort of feeling in my face...
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3- 4 minutes after injection I had tingling in my lips and a strange numb sort of feeling in my face, and then some "rubbery" weakness in my arms and legs. Treated in an ambulance at vaccine site with IV Benadryl, had some skin tingling, also given IV solumedrol and observed for almost 2 hours with no other symptoms. I was also hypertensive, probably due to anxiety.
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| 68 | 2021-03-02 | musculoskeletal stiffness |
About two hours after receiving the Pfizer vaccine shot #1, my left arm became numb and stiff, start...
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About two hours after receiving the Pfizer vaccine shot #1, my left arm became numb and stiff, starting at my wrist and worked up my upper arm. I could not lift my left arm at all, but when I tried, the pain was severe and radiated over the left half of my chest and over my heart. I thought this might be a passing reaction, and went to bed early. My condition was the same in the morning, and I contacted my doctor, who directed me to go to the emergency room or to Urgent Care, which I did.
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| 68 | 2021-03-02 | muscle pain, joint pain |
Soreness in injected arm, chills, dizziness, headache, muscle pain, joint pain, nausea, general mala...
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Soreness in injected arm, chills, dizziness, headache, muscle pain, joint pain, nausea, general malaise, lasting almost 2 days
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| 68 | 2021-03-02 | muscle pain |
severe stomach flu like symptoms; protracted vomiting; nausea; abdominal cramping; muscle aches; inj...
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severe stomach flu like symptoms; protracted vomiting; nausea; abdominal cramping; muscle aches; injection site reaction; This is a spontaneous report from a contactable other hcp (patient). This 68-year-old female patient (pregnant no) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number En6200), via an unspecified route of administration on 20Feb2021 10:30 AM on left arm at single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medication included rosuvastatin and hydrochlorothiazide/losartan. The patient experienced injection site reaction and severe stomach flu like symptoms, nausea, protracted vomiting, abdominal cramping and muscle aches on 20Feb2021 19:00. The patient had not received other vaccine in four weeks. There was no treatment received, no COVID prior vaccination and no COVID tested post vaccination, no known allergies. The outcome of the events was recovering.; Sender's Comments: Drug causality for suspect drug BNT162B2 in the onset of the reported events cannot be excluded . The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 68 | 2021-03-02 | muscle pain |
Muscles in arm hurting; This is a spontaneous report from a contactable consumer (reporting for hers...
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Muscles in arm hurting; This is a spontaneous report from a contactable consumer (reporting for herself). A 68-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date: May2021), via an unspecified route of administration in her right arm from 21Dec2020 07:15 to 21Dec2020 07:15 at SINGLE DOSE for COVID-19 immunization. There was no medical history and concomitant medications reported. In Dec2020, the patient experienced that the muscles in her arm started hurting. The outcome of the event was not recovered.
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| 68 | 2021-03-02 | neck pain |
About an hour after I received the vaccine my entire head was in pain including upper jaw and back o...
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About an hour after I received the vaccine my entire head was in pain including upper jaw and back of neck. My face was flushed and my throat began to tighten a little The headache and flush lasted about an hour. (I had taken Tylenol right after getting the vaccine.) The throat symptoms lasted longer ,lessening slightly after about an hour and a half. Never had trouble breathing, talking, eating or drinking. But the feeling has lasted into the late evening to a very mild degree; as if something is caught at the back of the throat, or the back of the tongue feels a little fuzzy.
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| 68 | 2021-03-03 | muscular weakness, limb discomfort |
Patient is a 68 y/o female who enrolled in program on 9/19/2018 who began monotherapy treatment with...
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Patient is a 68 y/o female who enrolled in program on 9/19/2018 who began monotherapy treatment with Pioglitazone 15mg PO on 10/5/2018. Patient called study team stating that she received her second Pfizer COVID-19 vaccination on 02/19/21. Afterwards, she had a sore arm and slept most of the next day. On 02/21/21, she experienced severe right-sided leg weakness and fell while attempting to go to the bathroom. She was unable to ambulate and her son took her to the emergency room. She was hospitalized overnight for a serious adverse reaction to the second Pfizer COVID-19 vaccination. Multiple sclerosis exacerbation was ruled out after extensive testing. Then, she was transferred a Rehab facility on 02/22/21 for physical therapy and occupational therapy. She continues study medication without any missed doses. She will most likely be in Rehab for another week. She was able to walk 80 feet on 2/25/2021 with a walker and gait belt and ambulatory assistance. This is unrelated to study drug. We consider this to be a Non-UP SAE. As of 3/4/2021 the patient is still in rehab.
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| 68 | 2021-03-04 | joint pain, muscle pain, musculoskeletal stiffness |
6-8 hours after the injection noted chills, fever and chills alternating, weakness, headache, joint ...
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6-8 hours after the injection noted chills, fever and chills alternating, weakness, headache, joint pain and stiffness., muscle soreness. Noticed voice hoarseness. Attempted to sleep after taking Advil with nightmares and restlessness. Felt this overall feeling of crying and uncontrolled sobbing. I had COVID in May of 2020 with hospitalization, Remdesivir IV. Pneumonia . July I was feeling better with noted Shortness of Breath not brought on by activity. I was able to resume my exercise activity. I walked but no longer able to walk 3-4 miles per day. I am walking 2 miles w strengthening exercise. The headache comes and goes with the addition of Advil and Tylenol alternating takes the edge off. I take a Zyrtec but it does not help
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| 68 | 2021-03-04 | joint pain |
Right elbow became inflamed, red, warm and painful. Right upper arm was sore. Became dizzy at 11 A...
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Right elbow became inflamed, red, warm and painful. Right upper arm was sore. Became dizzy at 11 AM on 3/2 and slept for 3 hours. All expect the inflamed elbow were not a surprise. I treated my elbow with an ice pack during the day on 3/2 and by 3/4 it had improved. By 3/5 it was no longer inflamed, red or warm, but is still tender to lean on. I informed my doctor's office of this.
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| 68 | 2021-03-04 | joint pain |
general moderate joint pain, chills, moderate headache, fatigue mostly gone by the morning of 3/5/2...
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general moderate joint pain, chills, moderate headache, fatigue mostly gone by the morning of 3/5/2021
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| 68 | 2021-03-05 | joint pain |
The injection site appears to be too high on my left shoulder and not properly placed in the deltoid...
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The injection site appears to be too high on my left shoulder and not properly placed in the deltoid muscle. I developed severe left shoulder joint pain by the afternoon March 5. By bedtime, the pain was excruciating and continues to be severe, not in my arm, but in my left shoulder joint. I had adhesive capsulitis several years ago and completely recovered, but it took two years to get back my health plus a steroid injection and physical therapy. I know what adhesive capsulitis feels like. And this is what my left shoulder socket feels like now. I had no idea this was a risk of a vaccination. I have sent an email to report this injury to UCSF and also requested an appointment with my doctor. This type of injury from vaccination should be avoided and is avoidable.
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| 68 | 2021-03-05 | muscle pain, joint pain |
rash on lower back within an hour after vaccine. It disappeared soon. At 2:00 am on March 4th - wo...
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rash on lower back within an hour after vaccine. It disappeared soon. At 2:00 am on March 4th - woke with severe headache, musle and joint pain, chills, nausea, genarlly feeling unwell.
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| 68 | 2021-03-06 | joint pain |
Tightness in chest, chills, sore throat, fatigue extreme, headache, bodyaches and joints, blurry eye...
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Tightness in chest, chills, sore throat, fatigue extreme, headache, bodyaches and joints, blurry eyes, nausea, no appetite.
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| 68 | 2021-03-06 | back pain |
Ten days after the first shot and four days after the second shot I experienced two episodes of che...
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Ten days after the first shot and four days after the second shot I experienced two episodes of chest tightening, increased heart rate, and pain that radiated around to my back. Each episode lasted about 15 minutes. During the second episode, I checked my heart rate on my watch. It was 110+.(I forgot to do it the first time) Both times I was sitting down doing a jigsaw puzzle . Not exactly stressful or physically taxing.
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| 68 | 2021-03-06 | muscle pain, back pain |
once I got my shot I got muscle pain in my entire back. It has lasted 7 days. If I move around it go...
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once I got my shot I got muscle pain in my entire back. It has lasted 7 days. If I move around it goes away but as soon as I stay still it?s starts hurting. Not quite as bad as the first day but still very painful
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| 68 | 2021-03-06 | muscle pain | Severe shaking, muscle aches, chills |
| 68 | 2021-03-07 | joint pain, groin pain |
I had body aches and I had pain in my right wrist. After my second dose on 2/25/2021 I had pain in m...
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I had body aches and I had pain in my right wrist. After my second dose on 2/25/2021 I had pain in my left groin joint and cannot walk. 2nd dose of Pfizer received in my left arm lot#EL9266 on 2/25/2021
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| 68 | 2021-03-07 | joint pain |
Fever, chills, joint pain, headache, swelling at the injection site. All but swelling resolved afte...
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Fever, chills, joint pain, headache, swelling at the injection site. All but swelling resolved after 48 hours. Injection site continues to have redness and swelling about 3 inches in diameter, 72 hours later.
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| 68 | 2021-03-07 | joint pain |
SITE WAS SORE FOR A COUPLE OF DAYS; SLIGHT FEVER THE FIRST AND SECOND DAY; TEMPERATURE ROSE BUT NOT ...
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SITE WAS SORE FOR A COUPLE OF DAYS; SLIGHT FEVER THE FIRST AND SECOND DAY; TEMPERATURE ROSE BUT NOT MUCH. UPON WAKING DAY TWO, I HAD A VERY PRONOUNCED ACHE IN THE BACK OF LEFT SHOULDER AND THE ACTUAL SHOULDER BLADE WAS SORE AND PAINFUL TO THE TOUCH. I DID NOTHING THE FIRST DAY OF THE DISCOMFORT (THINKING IT WOULD GO AWAY). I NOW APPLY CBD/THC BALM ON THE AREA 3 TIMES A DAY AND I'VE BEEN TAKING EXTRA STRENGTH TYLENOL , TWO TABLETS, THREE TIMES A DAY. I AM SLEEPING IN A ZERO-GRAVITY MODE ON MY SLEEP NUMBER BED...OTHERWISE I CAN'T SLEEP AT ALL. I HAD A HOLE IN MY ROTATOR CUFF SURGUCIALLY REPAIRED ABOUT 18 MONTHS AGO AND THE PAIN I HAVE NOW ACTUALLY FEELS LIKE MY SHOULDER FELT BEFORE AND FOR AWHILE AFTER THE SURGERY! I AM BEGINNING TO WONDER IF THERE IS A RELATIONSHIP TO THE TWO EVENTS.
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| 68 | 2021-03-07 | joint pain | Joint pain in knees, shoulders and hands. Three weeks thus far. |
| 68 | 2021-03-08 | joint pain |
I received the first vaccine around 10:00 in the morning. Symptoms hit about Midnight. Started wi...
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I received the first vaccine around 10:00 in the morning. Symptoms hit about Midnight. Started with a headache, a mild sore throat, fever 100.1, body and joint aches, chills, and then a few times the next day of being extremely tired, only lasted for about 24 hours. After the second vaccine, I had all of the previous symptoms again but this time the chills lasted for about 3 hours which was a lot longer. Lasted again about 24 hours and then a few times of feeling extremely tired the next couple of days. I should also let you know that I did test positive for COVID around November 6, 2020, and had mild symptoms for a full week.
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| 68 | 2021-03-09 | muscle pain |
11 hrs after shot I had a very bad case of diarrhea. A day later my left arm muscle was very sore (...
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11 hrs after shot I had a very bad case of diarrhea. A day later my left arm muscle was very sore (not the injection site, the whole upper arm muscle). Three weeks after the shot, my arm is still very sore and I can hardly use my left arm. It's very painful to get dressed, take off a jacket, shirt, etc. I can hardly use the left arm to hold anything due to the pain in the muscle.
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| 68 | 2021-03-10 | joint pain |
Within 30 minutes started a dry cough which lasted for 3 weeks. (Had a dry cough off and on before ...
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Within 30 minutes started a dry cough which lasted for 3 weeks. (Had a dry cough off and on before but had gotten better, possible long haul from flu last Feb/March that lasted 3 weeks. Not tested, so could have been Covid 19.) Severe chills and joint pain and fever like symptoms through out the night. - Better in the morning but still slight flu like symptoms, but only lasted 48 hours. However, the dry cough lasted 3 weeks.
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| 68 | 2021-03-11 | joint pain, muscle pain |
Fever, general malaise, extreme fatigue, aches in muscles and joints. Began late evening the day of...
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Fever, general malaise, extreme fatigue, aches in muscles and joints. Began late evening the day of the injection, about 6-7 hours after. Lasted a little over 24 hours.
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| 68 | 2021-03-11 | joint pain | fever 100 chills achy joints mild headache |
| 68 | 2021-03-11 | muscle pain |
Injection Friday 2/16, Saturday 2/27 afternoon, common symptoms, fever, chills, muscle aches. Sunday...
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Injection Friday 2/16, Saturday 2/27 afternoon, common symptoms, fever, chills, muscle aches. Sunday 2/28 through Monday Tuesday 3/2 nausea; Wednesday 3/3 vomiting, Thursday 3/4 nausea, Friday 3/5 nausea, Saturday vomited 2 times went to emergency room, Sunday 3/7 - Wednesday 3/10 nausea, Thursday vomiting, still nauseous.
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| 68 | 2021-03-12 | musculoskeletal discomfort |
I initially felt tired. As the day progressed I noticed discomfort in my joints. I also noticed wh...
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I initially felt tired. As the day progressed I noticed discomfort in my joints. I also noticed what I would describe as discomfort in the lymph system. Also, I have difficulty thinking clearly. Tasks that I usually complete easily such as online banking have been more difficult. I'm making mistakes. As I write this I am now three days from the inoculation. I have burning pain under my right arm. I have burning pain in tops of my feet. My hip joints are stiff. My eyes are sore. I feel generally fatigued. This is not my normal level of functioning.
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| 68 | 2021-03-13 | armpit pain | Pain in left armpit, swelling and soreness at injection site, fatigue |
| 68 | 2021-03-14 | back pain | Severe arm pain followed the next day by severe mid- and lower back pain |
| 68 | 2021-03-15 | joint pain, neck pain |
The injection was given to me as if I was a dartboard . The pain I had when I got home was so bad, a...
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The injection was given to me as if I was a dartboard . The pain I had when I got home was so bad, and ran across back of my neck to other shoulder. I feel she injected to high up and close to shoulder ...and pain went down my left arm to hand ...also pain was radiating up back of neck... this was very concerning to me... 2-3 days with this symptom
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| 68 | 2021-03-15 | joint pain |
2:00 AM awoke with joint pain. Took 2 Advil and went back to bed. This medication aleviated the pai...
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2:00 AM awoke with joint pain. Took 2 Advil and went back to bed. This medication aleviated the pains. Slight chills during the day (put on extra sweater), fatigue all day, napped off and on all day. Symptoms gone by next morning.
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| 68 | 2021-03-15 | joint pain |
Light-headed; Pressure in my chest; Pressure on my jaw and shoulder, my left shoulder; pressure on m...
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Light-headed; Pressure in my chest; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head; Arm was sore; Had light headache; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration on 22Jan2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) taken daily. The patient experienced light headedness and pressure in her chest that went to her left shoulder and jaw. Patient had light headache, pain in chest, and pain in jaw. She woke up this morning feeling better but still had slight pain in jaw. Wondering if side effects are from vaccine and will she be ok. Patient stated, "I have the first dose of the vaccine on 22Jan2021, I didn't have any side effect, my arm was sore but nothing big. But yesterday I feel light headed, like pressure in my chest, kind of pressure on my jaw and shoulder, my left shoulder, and my vitals were okay like my blood pressure, my heart rate and everything was normal. Further she explained this morning I felt better I didn't have pressure on my chest or anything but the pressure on my jaw that go up to my head. Is that related to the vaccine or is something that I have to worry about?" Consumer stated, "The second one is going to be on 12Feb2021, this Friday." Patient stated, "No, I was calling because today I feel better, I don't have the pressure on my chest. But I still have the pressure on my jaw and on my kind of my head. But no I have not called anybody. It's not like an emergency, I am calling because I was not sure about this is related to the vaccine." For treatment consumer stated, "No, today I took some Tylenol, that's all." No investigation assessment. The outcome of the event 'Light-headed' was recovering, the patient recovered from the event 'Pressure in my chest' on an unspecified date, was not recovered form Pressure on my jaw and shoulder, my left shoulder; pressure on my jaw that go up to my head and was unknown for other events. No follow-up attempts needed. No further information expected.
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| 68 | 2021-03-15 | joint pain | Headache, sore arm, joint aches |
| 68 | 2021-03-15 | joint pain |
First three days regular side effects, chills, fever, nausea and occasional dizziness (reported on a...
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First three days regular side effects, chills, fever, nausea and occasional dizziness (reported on app to CDC). Day 4 pain in right hip began. By day 7 rash had appeared on right buttocks and hip and below waist on right side. Day 12 formerly diagnosed with shingles.
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| 68 | 2021-03-15 | back pain |
chills all night , arm somewhat sore, when I got up to use the bathroom my heart pounded vey hard an...
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chills all night , arm somewhat sore, when I got up to use the bathroom my heart pounded vey hard and could feel below the esophagus area, March 12 at 6:30 am T 99.9, BP 151/85 achy , took tylenol and at 8:40 am BP 128/ 74 P 93, my back ached all day, 3:45 pm BP 141/74 P 90, Took tylenol for achy body, 6:00pm BP 158/82 P 84, 8:08pm BP 138/73 P82 . Felt very tired and slept in my chair 3:30- 6:00 pm, felt really exhausted and went to bed early : slept 9:00pm-7:00 am . Saturday 3/13 /21 felt better T 97.3 BP124/69 P 64 felt fairly good all day but tired
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| 68 | 2021-03-15 | bone pain |
Enlarged lymph node and pain at collarbone after receiving first Dose 1 on 2/22/2021. Pain and swel...
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Enlarged lymph node and pain at collarbone after receiving first Dose 1 on 2/22/2021. Pain and swelling had alleviated itself after 7 days. Then after Dose 2 on 3/15/2021 same incident occurred, but more severe. Waiting to see if the pain and swelling goes away.
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| 68 | 2021-03-15 | joint swelling | Swelling on my ankles. No medication, was advised to relax and elevate feet. |
| 68 | 2021-03-17 | back pain |
#1 2/15/21 Pfizer - lump under arm 2-3 days, right side back pain - took muscle relaxer and aleve fo...
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#1 2/15/21 Pfizer - lump under arm 2-3 days, right side back pain - took muscle relaxer and aleve for 2 days, better, #2 3/8/21 - lump under arm, palpitations 3/9/21 lasting 1 1/2 days, left side swelling on back 3/15/21, went across lower back, by 3/17/21 back pain worse and felt like couldn't breathe due to back muscle spasms went to ED, sore but better today 3/18/21
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| 68 | 2021-03-17 | muscular weakness |
a significant headache this morning with pain focused at the front of her head; Weak feeling; feelin...
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a significant headache this morning with pain focused at the front of her head; Weak feeling; feelings of weakness in her legs when walking; sore throat; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263) solution for injection, intramuscular on left deltoid on 26Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medication was reported as none. The patient received the first dose of COVID vaccine on 26Jan2021 and reported a significant headache this morning with pain focused at the front of her head after she was up for a while, she also had a weak feeling, feelings of weakness in her legs when walking and a sore throat, all on 02Feb2021. Her headache was very bad, but after treating with 2 tablets of extra strength paracetamol (TYLENOL) 500 mg, her headache was not as bad as it was. This happened suddenly. Her sore throat started the same time as the headache which was currently gone. She wanted to know if these events could be from the vaccine, a week later; if she should get a COVID test; and how long will the headache last if it came back. The outcome of the headache was recovering and recovered on 02Feb2021 for all other events.
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| 68 | 2021-03-18 | joint pain, muscle pain | Nausea joint pain muscle pain headache tiredness |
| 68 | 2021-03-18 | musculoskeletal stiffness, joint pain, back pain |
pain became more intense & the now has gone up to my mid back & shoulders/pain is constant burning,s...
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pain became more intense & the now has gone up to my mid back & shoulders/pain is constant burning,soreness,aching; pain became more intense & the now has gone up to my mid back & shoulders; pain became more intense & the now has gone up to my mid back & shoulders; Its to the point where it hurts to walk & I trip a lot; stabbing & stiffening; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201; expiry date: unknown) via an unspecified route of administration in the right arm, on 19Feb2021, at a single dose, for COVID-19 immunisation. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a Public Health Clinic/Veterans Administration facility. Medical history included chronic obstructive pulmonary disease (COPD). She had about 3 surgeries in lumbar area for fusions due to scoliosis in the past years (history of failed lumbar fusions due to scoliosis). Last one was about 5 years ago. Concomitant medications included roflumilast (DALIRESP), duloxetine, loratadine, montelukast sodium (SINGULAIR) and "Spiri". The patient previously received pethidine hydrochloride (DEMEROL) and experienced allergies; and previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264) in the right arm, on 28Jan2021 at 14:00, for COVID-19 immunisation and experienced a little lower back, bilateral hip and groin pain on 30Jan2021. The pain increased as time went on. On an unspecified date in Feb2021, after second injection, the pain (from first injection) became more intense and now has gone up to mid back and shoulders to the point where it hurts to walk, and she trips a lot. Nothing controls the pain including narcotics, heat, ice, Tylenol or ibuprofen. The pain was further described as constant burning, soreness, aching, stabbing and stiffening. The events were considered serious as the events resulted in disability or permanent damage. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.; Sender's Comments: Based on temporal association a contributory role of bnt162b2 to the reported events cannot be totally excluded. The patient's history of scoliosis and failed lumbar fusions may also be contributory to the events. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-03-18 | muscle pain | Low grade fever, muscle aches, severe headache, chills |
| 68 | 2021-03-19 | muscle pain, joint pain |
Severe chills for 1.5 hr despite multiple heated blankets, comforter, etc.; high fever, severe heada...
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Severe chills for 1.5 hr despite multiple heated blankets, comforter, etc.; high fever, severe headache (pain in ears and eyes as well as head), severe muscle and joint pain body-wide, skin painful to touch. Symptoms so severe that sleep was impossible for most of night. Headache severity lessened by 8a.m. 3/20, but is still present, and widespread joint pain, myalgia and fatigue continue up to the time of this report (24 hrs after injection).
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| 68 | 2021-03-20 | joint pain, back pain, neck pain |
1st night: arm pain peaked in the middle of the night, but better by morning 3 days after injection...
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1st night: arm pain peaked in the middle of the night, but better by morning 3 days after injection: had pain in left shoulder blade and about 5-6" radius of very tender scalp that hurt to barely touch 4 days: left shoulder blade pain better....tender scalp remains 5 days: pain has moved up toward shoulder..lesser pain on scalp 6 days: left shoulder pain gone, but now have arthritis type pain in left shoulder and back area and neck area...still some scalp pain 7 days: continued arthritis type pain in left shoulder and back area and neck area...still some scalp pain 8 days: still a little arthritis pain in left shoulder and back area and still a little scalp pain for the shoulder blade, shoulder, back and neck pain, I used ice
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| 68 | 2021-03-20 | joint pain, muscle pain |
Fever - 101; Muscle aches; Joint aches; Headache; Sinuses hurt; Chest hurt; Tired (All side effects ...
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Fever - 101; Muscle aches; Joint aches; Headache; Sinuses hurt; Chest hurt; Tired (All side effects were gone the next day with the exception of fever - I keep running a very low-grade fever 99.5 into day 3) 2nd day after injection - Injection site had redness going down to my elbow, very warm, and felt swollen
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| 68 | 2021-03-20 | back pain |
Next day nausea; severe back pain./Back pain lasted two days; Within 2 hours experienced dizziness; ...
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Next day nausea; severe back pain./Back pain lasted two days; Within 2 hours experienced dizziness; severe headache./After a week still have a headache.; Slight arm soreness; Severe exhaustion and slept 12-15 hours the first three days after shot.; Severe exhaustion and slept 12-15 hours the first three days after shot.; This is a spontaneous report from a contactable consumer. a 68-year-old female patient (consumer) received first dose BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection) via an unspecified route of administration (anatomical location: arm left) on 03Feb 2021 at 12:15 pm at single dose for COVID-19 immunisation. Patient Medical history included low thyroid. The patient's concomitant medication included levothyroxine. It was reported that no other vaccine was given within Four weeks prior to the vaccination. On 03Feb 2021 at 02:15 PM (same day of vaccination) Within 2 hours patient experienced dizziness and severe headache. Slight arm soreness. Next day nausea and severe back pain. Back pain lasted two days. Severe exhaustion and slept 12-15 hours the first three days after shot. After a week still have a headache. The patient prescribed treatment with Ibuprofen, tylenol and meloxicam. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event headache was not recovered and other events was Recovering. Information on Lot/Batch number has been requested
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| 68 | 2021-03-21 | joint pain | bad headache, fever, fatigue, body ached, hips hurt (hard to lay down or sitting) for about a day. |
| 68 | 2021-03-21 | joint swelling |
severe rashes, hives, swollen joints, fatigue (sleeping 19-20 hrs/day), pending biopsy results expec...
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severe rashes, hives, swollen joints, fatigue (sleeping 19-20 hrs/day), pending biopsy results expected to confirm Sweet's Syndrome.
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| 68 | 2021-03-21 | limb discomfort, neck pain |
Pain radiating from chest to left side of neck and left arm; Sore Swollen Lymph Nodes; Pain chest; A...
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Pain radiating from chest to left side of neck and left arm; Sore Swollen Lymph Nodes; Pain chest; Arm Pain, Left; Can't hardly use her left arm, it is so sore; This is a spontaneous report from a contactable nurse reported for herself. A 68-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot# EL9261, via unknown route on 12Feb2021 12:00 (at the age of 68-years-old) at left arm for COVID-19 immunization. The patient had not medical history. Concomitant medications were not reported. Vaccination Facility Type: Hospital. On 12Feb2021 the patient experienced left arm pain, pain chest, can't hardly use her left arm, it is so sore and on 14Feb2021 Pain radiating from chest to left side of neck and Swollen Lymph Nodes. Caller stated that she was thinking needs to go to the Emergency Room because it could be her lymph nodes, a blood clot, or her heart. She stated that she has been experiencing this since day one and nobody else has had side effects but her. She stated that this was out of the ordinary and according to the list she was given, it was not listed as a side effect. She was supposed to go tomorrow to get second shot, but she didn't think that she was going to be able to do it. No emergency room or physician office required. The outcome of the events at the time of last observation was reported as not recovered. Treatment was none. The events were assessed as serious, important medical events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 68 | 2021-03-22 | back pain, musculoskeletal discomfort |
initially post vaccine in 1st 10 min. BP sppiked along with heart rate; vision "off". After that all...
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initially post vaccine in 1st 10 min. BP sppiked along with heart rate; vision "off". After that all OK until I got up on the 18th. I had right groin "ache". Checked for enlarged Lymph nodes. Couldn't find. Rt hip has been replaced. I did have crown prepped on the 17th March 23h post covid Pfizer. I took Azathioprine 500mg prior to dental appt. The groin discomfort lasted until 3/22/21 night/none arising 3/23/21. Also had left groin and lower back and rt butt cheek discomfort 3/22/21. Of course with the replacement hip (2010) and dental, I am concerned the discomfort on the RHS is hip replacement related nit Covid but Pharmacist suggested I write it up.
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| 68 | 2021-03-22 | groin pain |
I had difficulty walking after approximately 27 hours of vaccination, severe pain in groin on both s...
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I had difficulty walking after approximately 27 hours of vaccination, severe pain in groin on both sides. Within approximately 48-72 hours I developed a severe bursitis on my left elbow, approximately 6 inches from the vaccination site - I had never had a bursitis before. The difficulty walking lessened after a few days, but I am still sore, possibly due to bursae by joints. I had a severe headache after approximately 48 hours which lasted for approximately 5 days. My arm is still sore at the injection site more than 2 weeks after the vaccination.
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| 68 | 2021-03-22 | musculoskeletal stiffness |
Soreness that does not resolve. Stiffness and inability to use full range of motion. After a month...
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Soreness that does not resolve. Stiffness and inability to use full range of motion. After a month my arm still aches and makes routine movement difficult.
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| 68 | 2021-03-22 | muscle pain, joint pain, muscular weakness |
very painful arm for a week, nausea, muscle pains and weakness, sharp pains in knees, dizziness, bra...
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very painful arm for a week, nausea, muscle pains and weakness, sharp pains in knees, dizziness, brain fog, all my skin felt like it a bad sunburn its still not back to my normal state, cronic sinus issues for about 2 weeks with headaches,
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| 68 | 2021-03-23 | joint pain | Excessive fatigue, severe arthritic body pain to entire body |
| 68 | 2021-03-23 | joint pain | Left shoulder pain; no other complaints |
| 68 | 2021-03-23 | muscle pain |
Headache, sore arm, fatigue, muscle pain, racing heart rate, difficulty breathing Fever (high of 101...
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Headache, sore arm, fatigue, muscle pain, racing heart rate, difficulty breathing Fever (high of 101.9) Body ache Chills Upset stomach/ no appetite
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| 68 | 2021-03-24 | back pain |
Transverse myelitis acute rapid onset 3/22/21 with severe right lateral mid back pain, rapidly progr...
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Transverse myelitis acute rapid onset 3/22/21 with severe right lateral mid back pain, rapidly progressing lack of bilateral lower extremity sensation and rapidly progressing within hours to complete paralysis with fecal and urinary incontinence
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| 68 | 2021-03-25 | weight decreased |
a few hours after getting the vaccine, my throat started burning, hard to swallow, then cough, low f...
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a few hours after getting the vaccine, my throat started burning, hard to swallow, then cough, low fever, body aches which continued from the 15th untill today 26th. lost 12 lb during this time, Weakness. Have never been this sick! My husband also had the same shot, same day, and started getting ill 5 days later, Cough, fever, nausea, unable to sleep. He is still ill today with dry heaves.
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| 68 | 2021-03-26 | joint pain, joint swelling |
Evening of the vaccination, there was joint pain. Day after the vaccination, the right knee became s...
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Evening of the vaccination, there was joint pain. Day after the vaccination, the right knee became swollen and very painful. This knee had been replaced the previous Sept. The swelling and pain lasted about 6 days. The swelling went down but did not diminish entirely. The pain went down but only somewhat, leaving consistent pain in the knee since then, Pain is evident upon walking, when sitting down or standing up and sometimes, when resting. I would not have tied this to the vaccine except that my husband, who also had a knee replacement, had the same reaction of swelling and serious pain for the same number of days, His knee replacement was done 5 years ago, and, he normally has no pain or swelling. His has cleared up.
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| 68 | 2021-03-26 | joint pain |
Paralysis of arm and hand on side (L) where vaccine was administered. Extreme pain (Fire -like) shoo...
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Paralysis of arm and hand on side (L) where vaccine was administered. Extreme pain (Fire -like) shooting up and down the leg on the opposite side (R) with very bad joint pain. This went off & on through the night/early morning in the first 22 hrs after vaccination. Woke with most pain gone, L hand red and sore, minor headache. Through out the following week I have experienced difficult pain and instability of some joints.
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| 68 | 2021-03-26 | joint pain |
Fever, headache, flu-like aches and pains--joint pain, miscellaneous stabbing/throbbing pains, nause...
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Fever, headache, flu-like aches and pains--joint pain, miscellaneous stabbing/throbbing pains, nausea, loss of appetite
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| 68 | 2021-03-26 | joint pain |
All adverse effects have lasted for six (6) plus days post-injection unless otherwise indicated: inj...
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All adverse effects have lasted for six (6) plus days post-injection unless otherwise indicated: injection site arm sore, fatigue, sleepiness, joint pain, diarrhea, bad nightmares for four (4) nights and bad dreams (unusual for me) for two plus nights after (I had nightmares after the first covid shot, too), minor dizziness for three days, chills, depression.
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| 68 | 2021-03-27 | joint pain | Fever 101 for one day, headache/body aches/joint pain for 3 days, fatigue for 4 days |
| 68 | 2021-03-27 | armpit pain |
Overcome with exhaustion suddenly, hot & cold, severe stabbing pain in armpit when laying down, head...
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Overcome with exhaustion suddenly, hot & cold, severe stabbing pain in armpit when laying down, headache in strange places in my head I felt better by morning, took 2 aspirin at 4am. I don't seem to have any appetite today, otherwise I feel OK.
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| 68 | 2021-03-27 | muscle pain, joint pain |
Sore arm a day after, night sweats 3 days after, stomach cramps 10 days after, muscular aches/joint ...
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Sore arm a day after, night sweats 3 days after, stomach cramps 10 days after, muscular aches/joint pain, body pain 17 days after, sinus drainage, sneezing etc, Headache,
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| 68 | 2021-03-27 | muscle pain |
For the first 3 days, intermittent chills and muscle aches in legs. On the 4th day, I felt back to ...
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For the first 3 days, intermittent chills and muscle aches in legs. On the 4th day, I felt back to normal. On the 5th day, I noticed a distinct increase in the volume of tinnitus in both ears, day and night. It sounds like constant high pitched white noise.
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| 68 | 2021-03-27 | muscle pain | Extreme fatigue, headache, muscle aches, reduced sense of smell & taste |
| 68 | 2021-03-28 | muscular weakness |
Two days after my second covid vaccine I had severe pain in both upper arms. I was unable to lift my...
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Two days after my second covid vaccine I had severe pain in both upper arms. I was unable to lift my arms above shoulder level. I also had weakness in both arms. The pain was worse in bed and I was unable to lift my arms at all from my sides. I saw Dr my fmaily doctor and was started on prednisone for 6 days. the pain subsided and movement returned. After the 6 days the pain returned as before. I also saw a pain specialist and 2 more visits to Family Dr. I had a second round of prednisone for 2 weeks and pain subsided mostly but has returned but not as bad after 2 weeks. I had 5 sessions of PT that helped somewhat
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| 68 | 2021-03-28 | musculoskeletal stiffness, neck pain |
Got the vaccine and within 3 minutes her left little finger went completely numb. Then a couple min...
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Got the vaccine and within 3 minutes her left little finger went completely numb. Then a couple minutes after that had a really severe stiff neck on the left side, painfully stiff neck. Then 5 minutes later felt like a knife was being jabbed into her left ear. She did not inform them of the reaction, and went home. The symptoms stayed the same and lasted for about an hour and a half and then all were completely gone. Her arm was a little sore, but mothing severe.
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| 68 | 2021-03-29 | joint pain |
Intense itching on foot which, at first looked like large open superficial blisters which became ver...
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Intense itching on foot which, at first looked like large open superficial blisters which became very painful open sores, which became deeper and more painful with swelling, oozing thick scabs, with swelling, and foot and ankle joint pain. 03/23/21, Doctors thought it might be shingles. It was difficult to walk for several days. Doctor did bacterial and viral swabs and prescribed antiviral med. on 3/24/2021, I got an itchy rash on my upper thighs that resembled chicken pox. Spots opened and scabbed over. Since then it has slowly spread on thighs.
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| 68 | 2021-03-29 | arthritis |
Extreme Tiredness for 4 days, major inflammation of joints affected by arthritis (still current), ou...
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Extreme Tiredness for 4 days, major inflammation of joints affected by arthritis (still current), outbreak of rash on face (still current), return of Candida Rash (resolved)
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| 68 | 2021-03-29 | limb discomfort |
pt states that immediately after taking the vax she got light headed and her limbs felt very very he...
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pt states that immediately after taking the vax she got light headed and her limbs felt very very heavy. Her BP was up to 192/90. They had her sit to monitor her BP and she became nauseas. She went to the ER. They continued to monitor her BP and she was given IV Benadryl. The heaviness in her limbs lasted many hours. Once her dizziness, heaviness in limbs, and her BP was 141/67 and still coming down she went home. Walking to her vehicle she had the dizziness, heaviness and was light headed again. When she got home she went to bed. Pt woke up having heart palpations. No chest pain or SOB. These palpitations lasted about 15 minutes. On 3/30/2021 she has some fatigue and a tightness around the top of her head. Pt has a FU appt w/ PCP on 3/31/2021.
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| 68 | 2021-03-29 | muscle tightness |
EXTREME SLEEPINESS. WEAKNESS, NUMBNESS ON WHOLE LEFT SIDE OF BODY, PINS AND NEEDLES FEELING THRU HEA...
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EXTREME SLEEPINESS. WEAKNESS, NUMBNESS ON WHOLE LEFT SIDE OF BODY, PINS AND NEEDLES FEELING THRU HEAD TO TOES, HEADACHE . NAUSEA SLIGHT FEVER , CHILLS, TIGHTENING FEELING NECK.AND CHEST. HAD TO TAKE TYLENOL PLENTY WATER HAD TO TAKE A SLEEPING PILL. NEXT DAY FELT BETTER BUT EXTREMELY TIRED,
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| 68 | 2021-03-29 | weight decreased |
3/26/2021 Note Nursing Assessment: Patient called through Office line ...
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3/26/2021 Note Nursing Assessment: Patient called through Office line Reason for Call WHEEZING Onset: 2 days ago Occurrence: acute Anatomical Location : na Severity: moderate Symptoms: Patient concerned about having asthma exacerbation. Started with cough and wheezing 2 days ago. Cough is productive but has not visualized the sputum. No fever. Having intermittent chest achiness in center of chest also. No known covid exposure. Had 2nd covid vaccine 2 days ago and states that 2-3 hours after the vaccine she began to have a "wheezing attack" and then it has continued since. Currently able to talk in full sentences but wheezing and having some breathing difficulty. Has not used Albuterol since last night. Any treatment So Far: Pulmicort, Spriva, and Albuterol Response: Helps for a little bit 3/26/2021 ED Visit CHIEF COMPLAINT: RESPIRATORY DISTRESS (began yesterday; says had 2nd covid vaccine weds and believes it "sparked my asthma"; hx of asthma/COPD. associated midsternal chest tightness) DIAGNOSIS at time of disposition: 1. COVID-19 ruled out 2. Bilateral pleural effusion 3. Acute cystitis without hematuria EKG NSR Chest x-ray showed no acute abnormalities showed stable mild cardiomegaly. CT results showed new small bilateral pleural effusions, right greater than left. Minimal bibasilar atelectasis mucus plugging. No airspace consolidation or PE noted. Patient reports that she was recently taken off her Lasix secondary to some weight loss and the fact that she had recently had surgery and oral intake was low. At this time, I do feel some of her symptoms may be related to fluid overload. Discharge 3/26/2021 3:59 PM 3/28 ED follow up. Pos urine cx. ABX started 3/29/2021 Called nurse triage. MODERATE difficulty breathing (e.g., speaks in phrases, SOB even at rest, pulse 100-120) of new onset or worse than normal. Told to go to ED. 3/29/2021 ED to hosp admission 28 hours. The encounter with the patient was in whole, or in part, for the following medical condition, which is the primary reason for home health care shortness of breath, anxiety, UTI, recent surgical intervention for bowel obstruction.
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| 68 | 2021-03-30 | muscular weakness |
Arms are weak, numb, tingly; Arms are weak, numb, tingly; Arms are weak, numb, tingly; Facial tingli...
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Arms are weak, numb, tingly; Arms are weak, numb, tingly; Arms are weak, numb, tingly; Facial tingling; Struggle to do anything with arms or hands; Struggle to walk; Exacerbation of MS following first dose of vaccine; Legs are weak, numb, tingly; Legs are weak, numb, tingly; Legs are weak, numb, tingly; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in the left arm on 04Mar2021 08:00 as single dose for COVID-19 immunization. The patient was vaccinated at a hospital. Medical history included multiple sclerosis from 1994 and ongoing Verbatim: MS. There were no concomitant medications. Historical vaccine included Tdap vaccine (DPT VACCINE) on 18Feb2016 for vaccination. The patient stated that she was looking for direction as well as reporting an exacerbation of MS following her first dose of the vaccine, clarified as the Pfizer Covid-19 vaccine, on 04Mar2021. Weight: Caller stated she would give her Covid weight. HCP: Caller reported that she is unsure of MD zip code. She reported that the phone number for her MD ends in DOCS but she did not know which numbers that corresponded to. Caller reported that she did not experience any of the common side effects from the first dose of the Covid-19 vaccine. She did not experience a sore arm, fever, muscle aches, none of that. She reported that she did not have any side effects until the afternoon of Saturday, 06Mar2021. Caller reported that she's had MS for many many years and that it has been in what she calls remission for a long time. She stated that the last exacerbation she experienced was following a Tdap vaccination five years before. Because of this experience, when the Covid vaccine came out, she went through her doctor to see what she should do, if she should get it. Her doctor recommended that she get the Covid-19 vaccine, but told the caller that she should make sure to go to a health care facility to receive it instead of drugstore or a clinic due to her experience following the Tdap vaccine in 2016. Caller reports that she is now having a similar exacerbation following the Covid-19 vaccine. Exacerbation of MS: Caller stated that it is an ongoing exacerbation that is not getting better. She stated that she's sure that it will get better, but she is not sure what she should do about the second dose. Legs weak, numb, tingly: Caller reported that the weakness, numbness, and tingling in her legs was progressive. She stated that the weakness, numbness, and tingling began on Saturday afternoon, 06Mar2021, in her feet and lower legs, and had then progressed to her thighs by Sunday 07Mar2021 or Monday 08Mar2021. Arms are weak, numb, tingly: Caller reported that she noticed on Sunday, 07Mar2021 that her hands were a little clumsy. She reported that throughout the day of Sunday, 07Mar2021 and Monday, 08Mar2021, the numbness and tingling progressed into her upper arm. Facial tingling: Caller originally stated that she has been experiencing a lot of nerve sensation, then clarified as facial tingling, in particular around the mouth, below the nose, and on both sides of her face. She stated that it began on Sunday, 07Mar2021 and was intermittently present on 08Mar2021 probably into 09Mar2021, then it just went away. She stated that it would come and go. Caller reported that while she is able to walk and has not had to use her wheelchair, that it is a struggle to walk. She also reported that it is a struggle to do things with her arms and hands. She stated that if she wanted to eat, in order to pick up the fork she would probably be using 2 hands to get the fork up but can use it once it's in her hands. She also reported that a pencil is difficult to pick up as well, stating that she would need to use both hands to pick it up but would be able to use the pencil once she had picked it up. Caller reported that the tingling comes and goes, and she experiences varying degrees of numbness. She reported that they are a little numb throughout the day and it may get worse depending on what she's doing. She stated that she isn't a sitter, she has to get up and move. Caller reported that she called her physician, about the side effects she was experiencing and they instructed her to go to the Emergency Room. She stated that their concern was what was going on and if it could be Guillain Barre disease, which she stated is extremely rare. Caller reported that when she went to the Emergency Room on 09Mar2021, they did not really do any tests. She stated that in order to see if there were any new lesions for the MS, they would have to do an MRI of her brain. Caller reported that they did not believe that there were any new lesions, that they thought it was old lesions. Caller reported that they told her to go home and make an appointment with the neurology resident clinic for that week, clarified as last week, week of 09Mar2021. Caller reported that she called the neurology clinic as she does not currently have a neurologist, and they informed her that they would not be able to get her in for an appointment until the end of Apr2021. She stated this was not doing her much good. Caller stated that they had wanted to admit her to the hospital, but told her that she could go home if she promised to follow up with the neurology resident clinic. Caller expressed some frustration, stating that she was really trying to reach out to see what she should do regarding the second dose. Her physician tells her to go to the Emergency Room, the Emergency Room tells her to go to neurology. She wants to know what will the second dose do. She stated that she called the (state) chapter of the national MS society this morning, where they informed her that they had not heard any reports of exacerbations from the Covid-19 vaccine. Caller states that getting additional doses of the Covid-19 vaccine is a lifelong decision. She stated that Covid may not always be a pandemic, but it could come back like a yearly flu. She stated that because additional doses of the Covid-19 vaccine could be required, she wanted guidance on how to proceed. Her second dose of the Covid-19 vaccine is scheduled for 25Mar2021. Clinical outcome of facial tingling was recovered on 09Mar2021, while for the rest of the events was not recovered. Information about Batch/Lot number has been requested.
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| 68 | 2021-03-30 | musculoskeletal stiffness | stiff shoulder, achy, tired |
| 68 | 2021-03-30 | muscle pain, joint pain, back pain |
Received my 2nd dose approx. 10:15am on 3/29/2021. Felt fine throughout the day, tried to stay busy ...
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Received my 2nd dose approx. 10:15am on 3/29/2021. Felt fine throughout the day, tried to stay busy & moving to allow vaccine to disperse. Watched TV that evening & noticed around 10pm that the shot site was beginning to ache & also felt a bit achy thru back & shoulders. By the time I went to bed around 11:30 I was having extreme freezing chills & muscle aches all over. I took a Tylenol before going to bed. Woke up at 2:30am & again at 4:30am due to extreme muscle pain from head to toe & still having freezing chills. Got up around 7am, still feeling achy but not chilling as much, however, felt slight nausea & weakness as though I was going to pass out. Sat down for a few minutes until I felt better. Throughout all day Tuesday March 30, the muscle aches abated but I continued to feel drained & had a constant headache. I took Tylenol to ease the aches.
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| 68 | 2021-03-30 | muscle pain |
Bad taste in my mouth (like bad feta cheese); Chills; then hot 98.7; (normal is 97.4); total body mu...
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Bad taste in my mouth (like bad feta cheese); Chills; then hot 98.7; (normal is 97.4); total body muscle aching; headache; This is a spontaneous report from a contactable consumer (patient herself) of 68-year-old female (age at the vaccination) received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 28Jan2021 09:00 AM as single dose for covid-19 immunisation. Vaccine was administered at facility. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient did not diagnose with covid-19 prior to vaccination and had not been tested for covid-19 since the vaccination. Patient medical history was included Stage IV breast cancer, hypo thyroid, elevated BP, pernicious anemia, low K, glaucoma BP and allergies to fish, shellfish, phenothiazines, cipro, cytoxin, morphine, demerol, codeine, sulfa, ampicillin, vancomycin, xylatan, alphagan. Patient's concomitant medications were included eribulin mesilate (HALAVEN) denosumab (XGEVA), amlodipine besilate (AMLODIPINE BESILATE), levothyroxine sodium (SYNTHROID), potassium (POTASSIUM K 20). On 28Jan2021 10:30 am the patient experienced bad taste in my mouth (like bad feta cheese), chills, total body muscle aching, headache. Patient underwent lab tests included body temperature results as hot 98.7 (normal is 97.4) on 28Jan2021 10:30. Patient had not received treatment for the events. The outcome of event was recovering.
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| 68 | 2021-03-30 | neck pain, armpit pain |
Fever, body aches, tiredness, headache, soreness on injection site, under the arm, up the neck and p...
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Fever, body aches, tiredness, headache, soreness on injection site, under the arm, up the neck and pain in the ear.
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| 68 | 2021-04-01 | joint pain, muscle pain |
sore arm (including right arm from first injection), temperature 100.8, hard shaking chills for eigh...
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sore arm (including right arm from first injection), temperature 100.8, hard shaking chills for eight hours (then low grade for 48 hours, very severe muscle pain, very severe joint pain accompanied by severe muscle cramps torso to feet for 48 hours, severe headache for at least 72 hours, drenching night sweats for two nights, nausea, bowel cramping and frequent stools, fatigue but inability to sleep, loss of appetite (but increased sense of smell).
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| 68 | 2021-04-01 | joint pain |
Injection site pain, tiredness, chills, joint pain, fever 103.4, nausea. All side effects resol...
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Injection site pain, tiredness, chills, joint pain, fever 103.4, nausea. All side effects resolved themselves within 24 hours.
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| 68 | 2021-04-01 | joint pain | Slight headache top of head Joint ache Injection site hurt |
| 68 | 2021-04-01 | joint swelling |
Patient reported swelling and pain on ankle 36 hours after receiving vaccine that lasted for 3 to 4 ...
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Patient reported swelling and pain on ankle 36 hours after receiving vaccine that lasted for 3 to 4 days.
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| 68 | 2021-04-01 | muscle pain, neck pain, joint pain |
12 hours after injection I developed several muscle aches. Extreme shivers and chilling. Fever. Head...
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12 hours after injection I developed several muscle aches. Extreme shivers and chilling. Fever. Headache unmanageable. Teeth, neck, jaws, eyes, shoulders all throbbed with extreme pain. Frontal lobe irritation! Loss of appetite. Sought Drs. Care after 12 hours. Meds for pain given. In bed and immobilized. Meds did help headache pain.. Injection of toradol then APAP/butalbital/caffeine every 4 hours. Head pain was a 10 of 10! Down to 5/10 with meds. I'm at the 48 hour mark with no let up in sight.
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| 68 | 2021-04-01 | muscle pain |
Initial sore injection site 6 hours after injection, slight headache 12 hours after, slight chills ...
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Initial sore injection site 6 hours after injection, slight headache 12 hours after, slight chills 16 hours after, tiredness and muscle pain 20 hours after and lasting 24 hours, red rash on front torso just below the breasts running in a 2-3 inch wide strip from left side to right side 36 hours after and lasting for 24 hours.
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| 68 | 2021-04-01 | muscle pain |
Got shot at hospital . ...sat for 15/20 minutes.....left to come home..noticed dry mouth, throat. ab...
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Got shot at hospital . ...sat for 15/20 minutes.....left to come home..noticed dry mouth, throat. about 10 minutes later I noticed i was having a hard time swallowing..i kept trying and trying and thought I better get somewhere, was on way to hospital and I started to be able to swallow. no idea what happened but was so glad i was able to swallow..I had severe muscle pain that night of the shot and the next 3 days. . Then later on the 3rd or 4th I noticed my bottom lip swelling, then it felt like my nose was swelling, tingly...then a hive came out on my face. I took an allergy pill and in about 30 minutes it started to subside a little...I called my Dr before I went back for the second shot and was advised not to take it.
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| 68 | 2021-04-03 | musculoskeletal stiffness | Moderate soreness and stiffness in arm, mild headache, mild fatigue |
| 68 | 2021-04-04 | arthritis, joint pain |
mild fatigue and worsened arthritis pain & swelling. 24 to 48 hours after vaccine (I'm writing abou...
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mild fatigue and worsened arthritis pain & swelling. 24 to 48 hours after vaccine (I'm writing about 48 hrs after injection so I don't know how long it will last.) The worsened arthritis may or may not be a side effect of vaccine because over the my degree of arthritis has varied in the past few years. However, it has worsened noticeably since the shot - although it within the range of previously experienced.
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| 68 | 2021-04-12 | joint pain, joint swelling |
had swelling and pain in her wrist; had swelling and pain in her wrist; her fingers turned a deep bl...
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had swelling and pain in her wrist; had swelling and pain in her wrist; her fingers turned a deep blue; caller was given some medication to dilate her blood vessels; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered on right arm on 17Mar2021 17:00 (Batch/Lot Number: EN6206) at single dose (at the age of 68 years old) for COVID-19 immunisation. The patient had no medical history. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. On 19Mar2021, the patient had swelling and pain in her left wrist, the following day her fingers turned a deep blue. The patient was sent to the hospital to rule out a blood clot, they couldn't find a clot and couldn't tell the patient if this was related to the vaccine. The patient was given some medication to dilate her blood vessels to take when the patient gets the second if she needs it. This happened in the opposite arm that the caller received the vaccine. The patient had an angiogram of the wrist on 21Mar2021, they injected dye into the patient's wrist then she went through the CT scan on 20Mar2021 and the results were negative. The patient was hospitalized on 20Mar2021 to 22Mar2021. The outcome of her fingers turned a deep blue recovered on 22Mar2021 and other events was recovered on Mar2021.
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| 68 | 2021-04-14 | joint pain |
This is the patient's spouse reporting. The day following the vaccination, wife began to suffer mil...
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This is the patient's spouse reporting. The day following the vaccination, wife began to suffer mild, common vaccination symptoms such as fatigue, hills, and joint pain. In the days following, in addition to those symptoms, she began to cough and had a sore throat. By March 8th, she had lost her sense of taste and sense of smell. We realized we needed to have her tested for COVID-19. We went to a testing area. She was seen and tested. She tested positive for COVID-19 (as did I). The belief was that our illness was uncomplicated and we were sent home with instructions to monitor our symptoms. On 03/14/2021, I took her to the hospital because her condition was worsening.
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| 68 | 2021-04-17 | limb discomfort |
feels tired; She did have palpitations overnight that woke her up in her sleep for 15 minutes; head ...
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feels tired; She did have palpitations overnight that woke her up in her sleep for 15 minutes; head feels tight, like there is a band around it/head feels tight, like there is a band around it; Nausea; severely lightheaded; her limbs felt heavy; her blood pressure went way up and lasted a good 7 hours/blood pressure at this time was elevated to 190/86; it was hard to lift her arms; This is a spontaneous report received from a contactable two nurses (one nurse reported for herself). This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6205 and expiration date: 30Jun2021), via an unspecified route of administration right arm on 29Mar2021 at 10:15 as single dose for COVID-19 immunization. Medical history included anaphylaxis (recovering), hypertension ongoing, gastroesophageal reflux disease (GERD), anemia (her hemoglobin dropped to 6.9 and ferritin was low), hiatal hernia surgery (had mesh), a latex allergy (her lips would start swelling) and food allergy (tuna fish). Family history included lung disease (her dad was diagnosed). Concomitant medications included hydrochlorothiazide (HCTZ) 25 mg, daily (been on it for 10 years) taken for high blood pressure from an unspecified start date and ongoing; losartan 100 mg, daily (for about 10 years) taken for hypertension from an unspecified start date and ongoing; iron (Tablet) 65 mg, daily (about 10 years ) taken for anaemia, cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication; The patient previously took cefalexin (KEFLEX) and experienced swelling on face and mouth, epipen, acetylsalicylic acid (ASPIRIN) (6 years ago aspirin sensitivity took place) and experienced haematuria, tolectin as nonsteroidal anti-inflammatory drug (NSAIDS) (about 30 years ago (received steroids, breathing treatments and benadryl) and experienced anaphylactic reaction, flu vaccine taken for flu (at 19 years old). The patient got first vaccine on 29Mar2021 and had an event. On the same day, she was severely light headed and her limbs felt heavy and her blood pressure went way up and lasted a good 7 hours. They had her in the emergency room. She did have palpitations overnight that woke her up in her sleep for 15 minutes but she had no chest pain or shortness of breath and then it went away. At first, she didn't feel anything, but then as soon as she got up to go to the sitting area where she was supposed to wait for 15 minutes, she became very very light headed, almost like there was a band around your head. there was no dizziness, but she was lightheaded and all four of her limbs felt really heavy, it was hard for her to move her limbs, she experienced nausea while sitting in the waiting area as well. She did not throw up and it started about an hour after the vaccine and describes the nausea as fleeting and states it lasted about a couple of hours, but not as long as the light headedness and heavy limbs. her blood pressure at this time was elevated to 190/86. the doctor there told them to send her to the ER. The reporter stated that the vaccine was given at the hospital, so they just wheeled her to the emergency department within the hospital, the doctor in the emergency room told her they didn't think it was an allergic reaction. after about 6 hours around 1600 her blood pressure finally came down to 141/67. She was discharged from the emergency room around 16:00 on 29Mar2021. At the time of discharge, the heaviness of limbs and light headedness had went away, but when she was walking to get to her car in the parking lot the lightheadedness and heaviness of her limbs returned. it was hard to lift her arms. she went home and went to bed, the lightheadedness and heaviness of her limbs went away after she was able to lay down and rest. Last night around 2:30 or 3:00am she woke up with heart palpitations. Caller states that these palpitations went away after 15 min and that she hasn't had this experience in years since hiatal hernia surgery. she felt much better next day, the only thing she felt today was tightness in her head but not a headache and just felt tired. The outcome of the events severely lightheaded, her limbs felt heavy, her blood pressure went way up and lasted a good 7 hours/blood pressure at this time was elevated to 190/86 and head feels tight, like there is a band around it were recovered in 2021; nausea was recovered on 29Mar2021; palpitations was recovered on 30Mar2021 and other events were unknown. As reported causality : Feeling light headed; Limbs felt really heavy; high blood pressure Related; head feels tight, like there is a band around it; heart palpatations Related. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported events and the administration of the suspect COVID19 vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 68 | 2021-04-18 | joint pain, muscular weakness |
01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21 4 days later I e...
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01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21 4 days later I experienced discomfort with burning,tingling radiating sensations in both knees,lower legs and feet for a few minutes. 01/22/21 symptoms returned and remained or more than 24 hours. After subsiding for several hours they returned 01/24/21 but progressed overnight up thighs to buttocks with 4 soft BM during night.01/25/21 I walked in to see PCP to report symptoms,exam and lab work drawn.01/27/21 tingling was experienced to upper thighs buttocks,perineum ,scapulae ,and fingers bilaterally,lasted briefly. 01/29/21 tingling in face. 02/01/21 pain in both arms. 02/02/21 weakness in legs,burning and cramping in both feet.02/04/21buttocks and thighs feeling heavy,tightness,numbness around nose,eyes and ear lobes,fatigue. 02/10/21 burning and tingling in 4th and 5th fingers of both hands radiating to elbows,hands unsteady. 02/12/21 MRI of brain and spine done,admitted to Hospital for worsening of symptoms including unsteadiness on feet, discharged 02/13/21. 02/14/21 Tingling in lips,tongue,speech halting and stuttering,head jerking,face twitching,shortness of breath,pounding heart. Speech abnormality returned on at least 6 different occasions. Mild headache,blurred vision,tightness in face,around eyes are occasional and transient since 03/22/21.Tingling and burning in feet and lower extremities and sporadic joint pain continue on and off with unsteadiness on feet and fatigue
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| 68 | 2021-04-24 | joint pain |
fever 103.4; Injection site pain; tiredness; headache; chills; joint pain; nausea; This is a spontan...
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fever 103.4; Injection site pain; tiredness; headache; chills; joint pain; nausea; This is a spontaneous report from a contactable consumer reporting for herself. A 68-year-old non-pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 30Mar2021 at 10:45 (Batch/Lot number was not reported) as a single dose (at the age of 68-years-old) for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing, and high cholesterol from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included pravastatin at 40mg taken for an unspecified indication, start and stop date were not reported; benazepril at 20mg taken for an unspecified indication, start and stop date were not reported; and esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) at 40mg taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever 103.4 on 31Mar2021 at 20:30, injection site pain on 31Mar2021 at 20:30, tiredness on 31Mar2021 at 20:30, headache on 31Mar2021 at 20:30, chills on 31Mar2021 at 20:30, joint pain on 31Mar2021 at 20:30, and nausea on 31Mar2021 at 20:30 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 103.4 on 31Mar2021. Treatment was not received for any of the events. The outcome of the events fever 103.4, injection site pain, tiredness, headache, chills, joint pain, and nausea was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 68 | 2021-04-24 | muscle pain |
chest pain; palpitations; experiencing consistent PVC's which is abnormal because I do not have any ...
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chest pain; palpitations; experiencing consistent PVC's which is abnormal because I do not have any Cardiac history; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; have a D-Dimer lab result of 758ng/ml as well as other abnormal labs; irregular heart rate and am going to have to more cardiac work up; extreme shortness of breath with minimal exertion; weakness; dizziness; very tired; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533), second dose via an unspecified route of administration, administered in Arm Left on 07Apr2021 14:15 (at 68 years old, not pregnant), single dose for covid-19 immunisation. Medical history included hypothyroidism, arthritis, all from an unknown date. The patient had her first dose of bnt162b2 for Covid-19 Immunization on Mar2021. The patient was taking unspecified concomitant medicines. The patient experienced within 5 minutes after receiving her second injection, she began having chest pain and palpitations. The paramedics ran a 4 lead EKG and she was experiencing consistent PVC's which is abnormal because she does not have any Cardiac history. She went to the emergency room and was noted to have a D-Dimer lab result of 758ng/ml as well as other abnormal labs. Still continue having PVC's and irregular heart rate and was going to have to more cardiac work up. Also have experienced other symptoms associated with actual COVID such as extreme shortness of breath with minimal exertion, weakness, dizziness, very tired. And muscle aches 2 days as of Friday 09Apr2021. All the events also reported as started 07Apr2021 14:15. The outcome of the events was not recovered. Treatment for the events was observation and medication. Patient was hospitalized due to the events for 1 day. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies.
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| 68 | 2021-04-26 | back pain |
Pt developed chest pain early am day following vaccine administration, presented to ED on 4/25 and w...
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Pt developed chest pain early am day following vaccine administration, presented to ED on 4/25 and was diagnosed with pulmonary emboli. She had recent muscle strain and chest/back pain that she attributed to lifting heavy objects the week prior to the vaccine (4/15), and had been mostly staying in bed or on the couch with minimal movement/activity 4/15-4/22 due to those symptoms.
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| 68 | 2021-04-27 | joint pain, neck pain, joint swelling |
aches and pain in her shoulder and neck; had exceptionally felt like she wanted to go to bed and nap...
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aches and pain in her shoulder and neck; had exceptionally felt like she wanted to go to bed and nap; She was not able to sleep and did not get up until 10 today; painful and hard; She stated to move her hair even to the touch it is painful; definitely something abnormal; Her hands, mainly her right, and ankles are swollen; Her hands, mainly her right, and ankles are swollen; congested in her chest; she is feeling a little confused; horrendous lumps on her head (some the size of a quarter, some a half dollar; fever; Excruciating pain in my head; peculiar neck pain/ aches and pain in her shoulder and neck; swelling of my arms and hands; Felt Achy; Felt off balance; chills; This is a spontaneous report from a contactable consumer reporting for herself. A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation . Medical history included thyroid mass (Diagnosed over 5 years ago. She never got a biopsy of it) , pelvic mass , cardiac disorder (Diagnosed when she was 49 or 50) , cardiac pacemaker insertion. The patient's concomitant medications were not reported. The patient experienced horrendous lumps on her head (some the size of a quarter, some a half dollar on an unspecified date with outcome of unknown , felt off balance on 12Apr2021 with outcome of not recovered , peculiar neck pain/ aches and pain in her shoulder and neck on 13Apr2021 with outcome of unknown , aches and pain in her shoulder and neck on an unspecified date with outcome of unknown , had exceptionally felt like she wanted to go to bed and nap on an unspecified date with outcome of unknown , she was not able to sleep and did not get up until 10 today on an unspecified date with outcome of unknown , painful and hard on an unspecified date with outcome of unknown , she stated to move her hair even to the touch it is painful on an unspecified date with outcome of unknown , definitely something abnormal on an unspecified date with outcome of unknown , her hands, mainly her right, and ankles are swollen on an unspecified date with outcome of unknown , congested in her chest on an unspecified date with outcome of unknown , she is feeling a little confused on an unspecified date with outcome of unknown , chills on 12Apr2021 with outcome of recovered , fever on an unspecified date with outcome of unknown , felt achy on 12Apr2021 with outcome of not recovered , excruciating pain in my head on 13Apr2021 with outcome of not recovered , swelling of my arms and hands on 12Apr2021 with outcome of recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 68 | 2021-04-30 | musculoskeletal stiffness |
today she is off kilter again; feels a heaviness in her eyes; all that coughing like something is ir...
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today she is off kilter again; feels a heaviness in her eyes; all that coughing like something is irritating her lungs and she can't stop; it was making her lungs hypersensitive.; all of a sudden she got really really hot, she runs about 97-97.4 and she got so hot and her face got really red like she had a high fever and she was 99.2; burning in her stomach and a stomach ache; burning in her stomach and a stomach ache; never has that much energy when she was normal/had tons of energy; woke up on day 4 in the middle of the night and her lungs were pinching, pinching, pinching, like and asthma attack and she couldn't stop it and she had to get her old fashioned inhaler to stop it; tired; had weakness with climbing stairs and with exertion/ zapping her energy; 2 inches below the injection site the muscle was hard and swollen and sore; 2 inches below the injection site the muscle was hard and swollen and sore; 2 inches below the injection site the muscle was hard; This is a spontaneous report received from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 07Apr2021 14:40 (lot number: EW0150) at age of 68 years as single dose for COVID-19 immunisation. Medical history included low vitamin D, lungs were working at 75% the capacity of an 84 year old and not 68 year old and asthma attacks. Concomitant medications included vitamin D2 and D3 and regular vitamins for low vitamin D, had been taking that for 6-7 weeks, tiotropium bromide (SPIRIVA RESPIMAT) 2.5mcg takes 2 inhales a day in the morning and salbutamol sulfate (PROAIR) 2 puffs and a special medication because her lungs were working at 75% the capacity of an 84 year old and not 68 year old and put her on an asthma medication to open her lungs. Patient got a flu shot every year and got it in Jan2021 and nothing. Patient stated that her symptoms were mild. Patient stated on day 1 after she got the shot she had nothing, that was 07Apr2021. Stated the next day (08Apr2021) she did not have injection site soreness but 2 inches below the injection site the muscle was hard and swollen and sore and remained that way for days 2, 3 and about day 4 it started to recede and day 7 it was tender. Stated it was one muscle and it was below the injection site, not at the injection site. Stated it was a lifting muscle, if she lifted her arm up it could only go so far and she would feel it and drop her arm down. Stated she got the injection in her left arm as she used it the least. Stated on days 2 (09Apr2021), 3 and 4 she had weakness with climbing stairs and with exertion, she could do it but she would notice it was more of a struggle. Stated that today she was off kilter again. Patient relayed that she looked all over online to see if she was sick with something. Stated she was tired on days 3 (10Apr2021) and 4 and that on days 5 (12Apr2021) and 6 she had tons of energy and she worked from dawn to dusk waxing floors and never has that much energy when she was normal. Stated that all of a sudden on day 5 and 6 she was perfect and then toward the evening of day 6 she thought it was her as she had to go to the Secretary of States and stand in line to renew her license and she did well and got home and started feeling tired. States she woke up last night of day 6 (13Apr2021) with a burning in her stomach and a stomach ache and it woke her and made her feel like she had food poisoning or something like that and nothing happened and she took 2 Tums and it kind of settled that down. Stated on day 7 (14Apr2021) she woke up and the stomach part was gone and all of a sudden she got really really hot, she runs about 97-97.4 and she got so hot and her face got really red like she had a high fever and she was 99.2, which is not much for most people but she feels and she took Motrin and after that she still feels a heaviness in her eyes and her temperature is 98.6 and she is normally in the 97's and was running a 2 degree fever and now maybe a 1 degree fever and she felt it in her eyes and didn't feel sick. Stated she felt fatigued like she want to take a nap but didn't feel ill. Stated whatever was going on was zapping her energy. Stated she woke up on day 4 (11Apr2021) in the middle of the night and her lungs were pinching, pinching, pinching, like an asthma attack and she couldn't stop it and she had to get her old fashioned inhaler to stop it. Stated this hadn't happened and she had been taking the special medication for 3 weeks now and it was very rare for her to get those attacks and this was worse than any. Patient relayed that today all day even with the special medication to open her lungs she can feel in her lungs that they were, she can't explain it, like they are gripping and releasing and gripping and releasing a little but. Stated she knew she was having some kind of asthma thing going on, it was not making her cough it was making her lungs hypersensitive. Stated she was expecting everything and she did read and nobody had symptoms that last more than 7 days and she was expecting them to be gone tomorrow, or she hopeed anyways. Stated the last 10 days had been easy-peasy and all of a sudden she was waking with all that coughing like something was irritating her lungs and she can't stop. Patient provided that it woke her husband up with her coughing for half an hour. States this lasted half an hour and was more than normal and something really irritated her lungs, shouldn't have happened as she is on the other thing every day and has not had an attack with that. Patient stated her provider didn't know as it was so relatively minor and was unusual but minor and she did not feel like it was life threatening. Stated her brother had Covid and she did not feel like she was trying to breathe and couldn't, or suffocating and dying. She did not feel that. The air irritated to even breathe and made her cough and couldn't stop and that was the first time she had to use an inhaler on top of on inhaler and something made her lungs respond to nothing there. Stated it may be her immune system thinking something was there, the headless thing in her lungs. Patient stated she thought she was over it and then got the fever not understanding if the fever was Covid related and she stayed at home and didn't go out until yesterday it was the 1st day out since Thursday and how could she have caught anything if she wasn't near anybody. Stated these were just thoughts in her head. Outcome of events was unknown.; Sender's Comments: The reported event of asthma aggravated was assessed as possibly related based on temporal association. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
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| 68 | 2021-04-30 | muscle pain, joint pain |
confused/When talking to her she is talking out of her head/hought her condo was turned completely a...
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confused/When talking to her she is talking out of her head/hought her condo was turned completely around; She is having headaches; muscle pain; chills; double vision; dizziness; her arm, and joint pain; her arm, and joint pain; extremely exhausted; This is a spontaneous report from a contactable consumer. A 68-year-old female patient (consumer's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 08Apr2021 (Batch/Lot number unknown as complainant does not have the product with them at the time of call) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was calling about her mother. The patient was fine before she got this shot and no one can seem to help her. They had the vaccine on 08Apr2021 and her mom (patient) started having severe reactions to it on 10Apr2021. Patient had the chills, muscle aches, muscle pain, headache, dizziness, her arm, and joint pain. She did not have fever, but had chills. She had double vision now. The symptoms are not going away. They are getting worse. They took her mom to the ER. The patient was confused. When talking to her she was talking out of her head. The severity of confusion is she thought her condo was turned completely around. Patient was not getting better. Went to the doctor and the doctor was at a lost. Patient was extremely exhausted. Caller stated they all took the same shot on the same day and her mom was the only one to have a reaction. Patient was literally out of her mind. Caller's dad had to take patient to the store with him because he didn't want to leave her by herself. They live in a condo on the second floor. Her mom thought the condo was reversed. Her dad was worried to leave her mom by herself because he didn't want her to go out the wrong door and go over the balcony. Her mom was not like that prior to receiving COVID19 Vaccine. Reporter was asked if there was an antidote. They were told patient should see her doctor and that she need treatment but no one could give they something to antidote the vaccine. The outcome of events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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| 68 | 2021-05-03 | muscle pain |
throbbing headache; exhausted; muscle aches; sick; fatigue; hands had tremors; body aches; This is a...
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throbbing headache; exhausted; muscle aches; sick; fatigue; hands had tremors; body aches; This is a spontaneous report from a contactable consumer. This 68-years-old Female consumer reported herself that: Country: Report about covid vaccine: Yes. Reporting type: AE. Reporter type: Non-healthcare Professional reporting for a patient. Patient name: (name). DOB: ## Age group: Elderly (65+ Years). Current age: 68. Current age unit: Years. Gender: Female. Is pregnant: No. Race: (race). Address street: (address). City: (city). State: (state). Zipcode: ### Phone no.: ## Email: (mail id). Covid vaccine details: Product=COVID 19 Brand=Prizer. Lot number= EN6198. Lot unknown= False Administration date=03Mar2021 Administration time=10:15 AM Vaccine location= Right arm. Dose number=1 Facility type vaccine: (name) Facility name: (name) Facility address street: (address) Facility city: (city) Facility state: (state) Facility zipcode: ### Facility country: If other vaccine in four weeks: No. Other medications in two weeks: Albuterol Inhaler. Adverse event: I had a throbbing headache in the back of my head that has lasted 12 days. It was the worst headache I have ever had and had terrible fatigue. My hands had tremors and I had body aches for 3 days. Headache so bad I had to get a CT scan Adverse event start date: 05Mar2021 Adverse event start time: 12:00 AM Adverse event country: Ae resulted in: Doctor or other healthcare professional office/clinic visit. If patient recovered: Recovering If treatment ae: Yes. Ae treatment: CT scan, Blood work. If covid prior vaccination: No. If Covid tested post vaccination: Yes. Covid test post vaccination: Covid test type post vaccination=Nasal Swab Covid test name post vaccination=Rapid Test Covid test date=12Mar2021 Covid test result=Negative. Known allergies: No. Other medical history: Cancer in remission for 6 years. Follow-up (23Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that included: Patient Details: Initials: (name). Sex: Female. Is the patient also the reporter? Yes Date of birth: ### Country of Incidence: Reporter Details: Reporter type: Consumer or other non health professional. Reporter type details: self. First name: (name). Surname: (name). Address line: (address). Town / City: (city). County / State: (state). Post code / ZIP code: ## Country: Telephone: ## Email address: (mail). Primary / Prescribing Healthcare Professional Info: Country: Event Details: Company aware date: 23Mar2021 Report type: Follow-up Report no new event Products: Suspect products: COVID Vaccine: NDC number: Not Provided. Lot Number: Not Provided. Reason for no lot number: Other: follow up report and she previously provided it. Expiry date: Not Provided. History: Concomitant Products: Other Products Not Provided. Other conditions: Other Conditions Not Provided. Investigations: Investigations Not Provided. Additional Context: Other Reference(s): No Transfer to agency Required. Additional Context: She had her first shot three weeks ago tomorrow. She is scheduled to get second one tomorrow. She was sick for 13 days after the first one. She was so sick. The headache was so bad the doctor sent her for a CT scan of her head. The headache was at the crown of the head and down into the back of the head. She never had a headache in the back of her head like that before. Her doctor wanted to make sure no bleed. It started lightly for two days and got worse and worse. It was 13 days before it went away. On top of that she had muscle aches in the beginning, but those went away. She was exhausted. She has already sent this in to Pfizer. She is questioning if she should get the second dose. She did get a COVID test and that was negative. She has done what she was supposed to do. Reference Number: she doesn't have a reference number. She has been on hold for two hours. She held because she feels this is very important. She really don't want to end up in trouble because she gets the second vaccine. Her doctor said it is a tough call. When she has to go get a shot and walk in with an EpiPen it gives her an ugly feeling. Her doctor is really not thrilled. She is darned if she does and darned if she doesn't. She knows one lady that died two days later and another one that died a couple of days later. They were both in another place. One was the wife of a surgeon. She thinks it has been reported. One was a community leader. They are waiting on the autopsies. Caller declined to proceed with a report for the two women that died after receiving the COVID vaccine. One died in the bathroom on the second day. The other is a doctor's wife and she passed one to two days after the shot. Neither was expected. Caller doesn't have their health records. She doesn't live in the same town. She is sure they are aware at Pfizer that this happened. She can't find anything. She didn't get a reference number from Pfizer. She gave the lot number when she reported it before because she remembered she had to get the card. She also reported it through (name). (name) gave her a confirmation number of ## on 13Mar2021. She think she would have filed them at the same time, so she probably reported it to Pfizer on 13Mar2021. Caller is going to delay the second shot. She knows she has up to 42 days. to get it. Is there a product complaint to report: No. Is there a medical information request: Yes. Please describe the medical information request: She is questioning if she should get the second dose. Is this an Other report: No Site: Call Centre # Contact Centre Ref: ##, ## Follow-up (23Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that included: Primary source(s) of information: Reporter title: (title). Reporter given name: (name). Reporter family name: (name). Reporter's postcode: ### Reporter country code: Qualification: Consumer or other professional. Reporter Phone Number: ### Patient characteristics: Patient: PRIVACY. Sex: male. Patient First Name: (name). Patient Last Name: (name). Drug(s) Information: Characterization of drug role: suspect. Proprietary medicinal product name: Pfizer-Biotech COVID-19 Vaccine. Identification of the country where the drug was obtained: Country of authorization/application: Active Substance Information: Active Drug substance names: Pfizer-Biotech COVID-19 Vaccine. Narrative case summary and further information: Case narrative: Originating AE Request: REQ-# Attachments: 1 Reporter Subtype: Patient. PQC Present: No. AE Present: Yes. PQC Details: Request Name: REQ-# Product: Pfizer-Biotech COVID-19 Vaccine. Question: Potential Duplicate case: Caller stated she reported this online to Pfizer safety on 13Mar. Caller received the first dose of the Pfizer covid vaccine on 03Mar and it made her sick for 13 days. She had a really bad headache for 9 days and had a CT scan done for the headache, she was in the hospital, was exhausted. Caller is scheduled for second dose tomorrow. caller wanted to know if the side effects lasted that long after the first dose with other people. caller is a 68 years old female. Caller stated she is not sure about if the 2 females who received the covid vaccine were Pfizer covid vaccine or not but they died in (place name). Caller refused to provide any other information including age of the patients. Caller stated that one of them was a Doctor's wife. Request Name: REQ-# Product: Pfizer-Biotech COVID-19 Vaccine. Question: Question: Caller wanted to know how many people experienced severe headache and were they given the second dose.
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| 69 | 2021-01-04 | muscle pain |
slightly painful enlarged left axillary node that is on ipsilateral side of injection; slightly pain...
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slightly painful enlarged left axillary node that is on ipsilateral side of injection; slightly painful enlarged left axillary node that is on ipsilateral side of injection; paraspinal muscle pain resolved by next day; In evening had mild pain site injection gone in a day; This is a spontaneous report from a contactable physician (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EK5730), intramuscular on the left arm on 20Dec2020 12:00 at SINGLE DOSE as COVID-19 immunization at the hospital. Medical history included Graves disease. The patient also had allergies with penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), acetylsalicylic acid (BABY ASPIRIN), and colecalciferol (VITAMIN D). It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 21Dec2020 in evening, the patient had mild pain site injection gone in a day (22Dec2020). On 22Dec2020 (day after injection), the patient then had paraspinal muscle pain resolved by next day (23Dec2020). The patient took ibuprofen (MOTRIN) in evening and gone by morning. Day 7 (28Dec2020), the patient noticed slightly painful enlarged left axillary node that was on ipsilateral side of injection which was still present (no treatment was received for the events). The patient recovered from the event of mild pain site injection on 22Dec2020 and paraspinal muscle pain on 23Dec2020 while not recovered for the remaining events.
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| 69 | 2021-01-05 | joint pain, limb discomfort, muscle pain |
Extremely tired, arms and legs felt like lead. Sharp pain top of ankles. Tireness, achiness, joint p...
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Extremely tired, arms and legs felt like lead. Sharp pain top of ankles. Tireness, achiness, joint pain, muscle pain, headache. Feeling unwell.
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| 69 | 2021-01-07 | muscle pain |
Injection site is red, swollen, hot. Muscle aches, feverish, headache general malaise. I took Tylen...
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Injection site is red, swollen, hot. Muscle aches, feverish, headache general malaise. I took Tylenol, Advil and used ice for the headache.. The side effects didn?t start until day after the vaccine. This is the third day post vaccine side effects are starting to subside.
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| 69 | 2021-01-10 | joint pain, armpit pain |
Fever ranging from 100.2 degrees F to 102.2 degrees F for 36 hours, moderate relief with Tylenol. ...
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Fever ranging from 100.2 degrees F to 102.2 degrees F for 36 hours, moderate relief with Tylenol. Joint pain for 72 hours with mild relief with Tylenol. Loss of appetite for 24 hours. Left deep armpit pain for 4 days, just subsiding but still evident. Left deltoid injection site warm and red with redness tripling in size over 3 days (covered entire deltoid region.) Site remains warm and red since initial injection but seems to be improving today (day 4 post vaccine)
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| 69 | 2021-01-14 | back pain |
experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pa...
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experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pains/aches and pains around her body; severe pain in injection arm; injection site very painful; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. She reported that the evening of her first dose, she experienced severe pain in injection arm on 06Jan2021. She stated that night injection site very painful. She had to take Tylenol Extra Strength overnight. She stated that she woke up and she was fine. On 09Jan2021, she reported feeling fatigued, dry cough, extreme fatigue, diarrhea, aches/pains, and aches and pains around her body, but no fever. She woke up this morning on 11Jan2021, experiencing pain in her back where kidneys, still fatigued but no fever. She has taken the Covid test and does not have the results. She wanted to know if these are side effects of the vaccine or is this potentially the Covid virus. The events were assessed non-serious. The outcome of severe pain in injection arm, injection site very painful was recovered, of fatigued was not recovered, of other events were unknown. Information on the lot/batch number has been requested.
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| 69 | 2021-01-16 | muscle pain | Headache Fever 100.3 Muscle ache Fatigue Pain at injection site |
| 69 | 2021-01-18 | arthritis |
Both left and right knees extending 6"above and below area, was extremely inflamed, warm to touch, p...
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Both left and right knees extending 6"above and below area, was extremely inflamed, warm to touch, painful making legs feel like 2 cement blocks to walk. Both shoulders were inflamed and muscles locked causing difficulty in mobility. Both hip joints felt irritated, the left more aggravated and painful. Also the body experienced being tired and sluggishness needing more than usual sleep. This lasting about 8 days. Treatment: ActivIce/Biofreeze spray several times daily and elevation to release pressure and blood flow.
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| 69 | 2021-01-19 | muscle pain |
Patient advises that she had developed injection site soreness on the night of her injection. The ne...
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Patient advises that she had developed injection site soreness on the night of her injection. The next day, she started with symptoms of generally feeling unwell and headache. She also reports that several days after the vaccine, she had some shortness of breath, dizziness, and weakness but did not seek medical care. Patient states she had fatigue, muscle pain, chills, sweating, and runny nose on 1/15/2021. On 1/18/2021, patient complains of headache. COVID test was ordered and patient was advised to go to Urgent Care for exam if she felt she needed to see a doctor. COVID test resulted negative.
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| 69 | 2021-01-20 | muscle pain |
anterior cervical fusion; Headache; tested positive for COVID-19; tested positive for COVID-19; musc...
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anterior cervical fusion; Headache; tested positive for COVID-19; tested positive for COVID-19; muscle aches; Loss of taste; Loss of smell; Nausea; sore arm; Tiredness; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot EJ1686, intramuscular in right deltoid on 03Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing essential tremor started in her 50's. The patient's concomitant medications were not reported. The patient did not receive other vaccine within four weeks. On 03Jan2021 the patient experienced sore arm and tiredness. On 07Jan2021 the patient experienced anterior cervical fusion and was hospitalized from 07Jan2021 to 09Jan2021. On 08Jan2021 the patient experienced nausea. On 09Jan2021 the patient experienced muscle aches, loss of taste and loss of smell. On unknown date the patient experienced headache. The patient was tested positive to COVID-19 on 11Jan2021. The patient did not visit Physician Office or Emergency Room. Laboratory data included COVID-19 Rapid Test positive on 11Jan2021. The outcome of the events tested positive for COVID-19, and anterior cervical fusion was unknown. The outcome of the events sore arm, tiredness, nausea, muscle aches, headache was resolving. The outcome of the events loss of taste, loss of smell was not resolved.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 03Jan2021, and COVID-19 test positive on 11Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. This 69-year-old female had medical history of ongoing essential tremor started in her 50's. The reported anterior cervical fusion was most likely due to concurrent disease, and unlikely causally related to the vaccine of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-01-22 | back pain, muscular weakness |
Extreme fatigue, headache, dizzy, backache, cold sore. General weakness especially in lower extrem...
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Extreme fatigue, headache, dizzy, backache, cold sore. General weakness especially in lower extremities - started 7-10 days after injection.
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| 69 | 2021-01-24 | neck pain |
At 6:00 AM, suddenly had severe pain in left side of neck, headache, extreme vertigo, chills and nau...
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At 6:00 AM, suddenly had severe pain in left side of neck, headache, extreme vertigo, chills and nausea. Multiple sessions of vomiting. Saw rings of colored lights and squigly lines. Took Tylenol and Benadryl per PCP by phone. Dizziness and chills went away in about 12 hours. Still saw squigly lines at night. Much better the next day but queasy for another 24 hours.
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| 69 | 2021-01-25 | joint pain |
Two days (Friday) after the injection (Wednesday) a pain arose in my shoulder muscle on my left side...
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Two days (Friday) after the injection (Wednesday) a pain arose in my shoulder muscle on my left side just behind the injection site. By Sunday afternoon the pain became debilitating and the pain spread to my underarm and the edge of the breast area. I applied heat and rested. The sharp pain interfered with sleep and regular life activities. On Tuesday morning I applied an ice pack, which relieved the pain. After applying ice for two more times, the pain subsided and the swelling under my arm disappeared. I was able to resume normal activities with slight discomfort.
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| 69 | 2021-01-25 | back pain, joint pain |
2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vom...
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2:00-chills all the way down my right side (2pm-7am Started throwing up...12 hours of nausea and vomiting 3:00-extreme headache (took aspirin for pain) -lower back hurt -pain in right shoulder, elbow, wrist -couldn?t lay on right side (bruising at site but no swell -couldn?t move without vomiting -woke up at midnight completely wet with sweat and sweating continuing even today Tuesday -weakness all over (felt like I had had the FLU) ? I knew there was potential for side effects before taking the vaccine...I was totally unprepared for so many symptoms and how intense they were and what little I could do to relieve any of them. Never had fever that I am aware of. Today I?m weak and sweating is unreal. ?? Should I prepare/expect my second dose around Feb. 14 to have the same effect on me.? Not looking forward to that. I was almost ready to go to the ER I was getting so dehydrated and weak.
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| 69 | 2021-01-25 | musculoskeletal stiffness |
sore throat, stiff neck, chills, body aches, nausea, headache (day 2 still have headache), extreme f...
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sore throat, stiff neck, chills, body aches, nausea, headache (day 2 still have headache), extreme fatigue, swollen lymph nodes, increased blood pressure, night sweats
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| 69 | 2021-01-26 | joint pain | Severe pain in right arm. Very little range of motion. Shoulder joint very painful. |
| 69 | 2021-01-26 | muscular weakness |
She having bilateral leg pain and weakness to the lower extremities. Low grade fever of 100.1. Was s...
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She having bilateral leg pain and weakness to the lower extremities. Low grade fever of 100.1. Was sent to ER for evaluation of leg weakness.
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| 69 | 2021-01-27 | musculoskeletal stiffness |
1st shot...none 2nd shot: 1st night-fever, headache, chills major all over stiffness ...
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1st shot...none 2nd shot: 1st night-fever, headache, chills major all over stiffness 2nd night- fever over 100 degrees, major chills and shivering, joint stiffness, no headache 3rd night- no fever but MAJOR sweating, sweating, sweating. No headache, stiffness much improved. 4th day - all symptoms almost gone, no headache, stiffness improved. Arm still sore
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| 69 | 2021-01-27 | muscle pain, limb discomfort |
After about 12 hours I started having muscle aches in both arms which then became full body ache lik...
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After about 12 hours I started having muscle aches in both arms which then became full body ache like flu symptoms. Fever chills during the night. Still had 99.5 fever at 7 this morning and dull headache. Took 2 Tylenol. Still sore but getting better.
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| 69 | 2021-01-28 | joint pain | Nasuea, Chills, Joint aches |
| 69 | 2021-01-28 | back pain, joint pain |
When I got the shot I sat out there 15 minutes to wait. I got an odor in my mouth. My nose started i...
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When I got the shot I sat out there 15 minutes to wait. I got an odor in my mouth. My nose started irritating a little bit. So then i left it alone because I didn't now if that was part of a reaction. When i got home i still had the odor in my mouth. i drank cold water and it went away. I waited. I felt sore on my arm but it wasn't that bad but as the hours went on it started getting more sore and painful. My arm was sore up to my shoulder and the back. After that the pain started traveling towards to my chest and i started getting pain in my chest. i took Tylenol (1 500 mg extra strength at 11:15 PM). So i waited 15 minutes to go to sleep. i got up the next day and everything was the same, i started putting ice on it and gave it time. I took another Tylenol but the pain was in my chest again a little bit. The third day the pain didn't come back in my chest and from then i was alright. I also started getting an itch.
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| 69 | 2021-01-28 | muscle pain | Fever up to 101.6, chills, headache, muscle soreness |
| 69 | 2021-01-29 | joint pain |
a few days after my covid shot my right should be to hurt. I am left handed and have had a torn rot...
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a few days after my covid shot my right should be to hurt. I am left handed and have had a torn rotor cuff in my left arm and now my right arm where the shot was given is having the same painful symptoms as a torn rotor cuff. Before the shot i had absolutely no problems with my right arm
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| 69 | 2021-01-31 | back pain |
feeling ill; headache; fever; tired; a slight cough; Nausea; Just an overall feeling of being sick n...
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feeling ill; headache; fever; tired; a slight cough; Nausea; Just an overall feeling of being sick not feeling well; Pain in my back that radiated between my shoulder blades and down and to my lower back like crossed my kidneys; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248), via an unspecified route of administration at Right arm on 12Jan2021 10:00 at SINGLE DOSE for COVID-19 vaccination. Medical history included diabetic, high blood pressure and possible Atrial fibrillation (AF). Concomitant medications in two weeks included lisinopril, atorvastatin, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient started feeling ill the day after the shot, she had a headache, fever, tired, a slight cough, Nausea, Pain in her back that radiated between her shoulder blades and down and to her lower back like crossed her kidneys. Just an overall feeling of being sick not feeling well. She was questioning whether she may have been exposed to Covid and she was experiencing Covid symptoms. The events started from 13Jan2021 01:00 AM and not recovered at the time of reporting. No treatment received, no covid prior vaccination, no covid tested post vaccination, no known allergies.
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| 69 | 2021-02-01 | joint pain, neck pain, musculoskeletal chest pain |
I give the girl in front of me the Covid vaccine way high on her arm. I told MA do not give my shot ...
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I give the girl in front of me the Covid vaccine way high on her arm. I told MA do not give my shot that high up. She said in a snide voice it?s still the deltoid and she shot my bursa. The evening of the shot I started having severe arm pain and nausea. The next morning I had right scapula rib pain it was hard to breathe my arm hurt very bad I can hardly lift it I went to work. When I got to work I couldn?t function I was so nauseated with the pain I went home that day and I?ve missed three days total from that event of wrong injection site. The pain has gotten worse I can?t lift my arm left right upper down without pain and it?s going into my neck and down to my elbow now I went to the occupational medical doctor. I told him what happened and he said she gave me the shot am I supraspinatus Bursa and I have an injury to my bursa. I came back for a second visit the next week and he said I have bursitis from that now I can?t raise and use my arm that well at all and I have severe pain 24 seven still and he sent me to a physical therapist starting today 2 to 21. It has gotten worse and my shoulder has locked up three times. I still have ongoing pain 24 seven and I want to report a complaint against the girl who gave my shot I thought she was an LPN but she is a MA. We both work at healthcare clinic. I am a 26 year RN and she did not listen to me and she stuck me anyway against my will.
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| 69 | 2021-02-01 | muscle pain, bone pain |
every bone and muscle in her body hurts, bad; every bone and muscle in her body hurts, bad; This is ...
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every bone and muscle in her body hurts, bad; every bone and muscle in her body hurts, bad; This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3249/expiration date: not provided), via an unspecified route of administration, on 16Jan2021 (at the age of 69 years old) as a single dose in the left arm for L121. Relevant medical history included lung cancer 10 or 11 years ago and she only has one lung that breathes well, pneumonitis due to radiation to her right lung which damaged the lining in her right lung, ongoing high cholesterol since 10 to 12 years ago, and high iron content due to simvastatin. Concomitant medication included simvastatin 20mg once daily orally since an unknown date for years, for high cholesterol. On 17Jan2021, the patient experienced every bone and muscle in her body hurts, bad and was worsened. The outcome of the events every bone and muscle in her body hurts, bad was not recovered.
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| 69 | 2021-02-01 | muscle pain | Some discomfort on injection, muscle soreness afterwards. No treatment needed. |
| 69 | 2021-02-03 | joint pain, neck pain, muscle pain |
Temperature of 101.5 -- chills - headaches - shoulder & neck pain - muscle pain - fatigue - vomiting...
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Temperature of 101.5 -- chills - headaches - shoulder & neck pain - muscle pain - fatigue - vomiting Feeling better on day 2
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| 69 | 2021-02-03 | muscle pain |
Injection site soreness; tiredness; muscle pain; feeling unwell; This is a spontaneous report from a...
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Injection site soreness; tiredness; muscle pain; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 14Jan2021 at 09:00 at a single dose in the hospital for COVID-19 immunization. Medical history included autoimmunity of unknown origin and seafood allergy. The patient is not pregnant at the time of vaccination. Concomitant medication included folic acid, methotrexate, multivitamins (vitamins nos), and fluoxetine hydrochloride (PROZAC). The patient experienced injection site soreness, tiredness, muscle pain, feeling unwell for 30 hours on 14Jan2021 at 12:00. The patient did not receive treatment for the events. Outcome of the events was recovered on 15Jan2021. Information on batch/lot number was requested.
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| 69 | 2021-02-03 | muscle pain |
INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, FEVER, INJECTION SITE SWELLING, INJEC...
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INJECTION SITE PAIN, TIREDNESS, HEADACHE, MUSCLE PAIN, CHILLS, FEVER, INJECTION SITE SWELLING, INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL FLU LIKE SYMPTOMS
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| 69 | 2021-02-04 | joint pain, muscle pain | Today I have muscle and joint pain, a headache and nausea |
| 69 | 2021-02-04 | muscle pain | Fever of 103.7, vomiting, diarrhea, myalgia, shaking chills, called 911 |
| 69 | 2021-02-05 | joint pain |
Patient developed sever immobilizing shoulder pain, which has persisted 15 days. Patient notes high ...
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Patient developed sever immobilizing shoulder pain, which has persisted 15 days. Patient notes high should administration. Probable bursitis/tendonitis.
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| 69 | 2021-02-05 | limb discomfort | Arm discomfort and swelling. |
| 69 | 2021-02-05 | neck pain |
Complain f neck pain after vaccination. EMS evaluated and suggested arm and neck exercised. Client i...
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Complain f neck pain after vaccination. EMS evaluated and suggested arm and neck exercised. Client improved and left facility. Had history of neck injury.
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| 69 | 2021-02-06 | joint pain, neck pain |
Severe migraine headache on morning following vaccine, affecting vision for about 30 minutes, took 2...
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Severe migraine headache on morning following vaccine, affecting vision for about 30 minutes, took 2 Tylenol 500mg each, had bad headache for rest of the day. Left arm pain that radiated into left shoulder and neck area, applied heat. Was awakened very early 2nd morning with headache, causing me to get up as hurt to lay head on pillow. Took 2 Tylenol, so far only slight decrease in pain.
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| 69 | 2021-02-06 | back pain, joint pain, neck pain |
Started within 2 hours of vaccine (8 pm) an extremely sore arm. Then the pain started to radiate to...
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Started within 2 hours of vaccine (8 pm) an extremely sore arm. Then the pain started to radiate to my shoulder. By the next day, it was really painful in my shoulder and across my back almost to my backbone. It was painful to move my arm up or down or to reach for things. This lasted 3 to 4 days. Then my neck on the same side as the shot (left) began to hurt so badly I couldn't move my neck up or down or sideways. It was strange the way the pain slowly moved across by arm to my shoulder to my back and up my neck. I've never experienced anything like this before. Today my pain in my neck is bearable but I have soreness and a headache. I hope I am at the end of the cycle to this event as I am scheduled for my next shot soon.
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| 69 | 2021-02-07 | muscle pain |
Patient complained of soreness in muscles morning after receiving the shot. She went about her day ...
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Patient complained of soreness in muscles morning after receiving the shot. She went about her day had a smoothie, spoke to people and also went for a walk came home and went into her jacuzzi tub and consequently passed away while in the tub. She was found by her husband at around 545pm, time of death is unknown and cause of death is currently pending.
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| 69 | 2021-02-07 | muscle pain |
felt like she was having the onset of pneumonia; muscle and body aches; muscle and body aches; ongoi...
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felt like she was having the onset of pneumonia; muscle and body aches; muscle and body aches; ongoing congestion in one nostril/stuffiness; felt tired and run down; feeling itchy/Her head, neck and back are very itchy; rash/like a fever type rash; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3249, unknown expiration), via an unspecified route of administration in the left shoulder area on 16Jan2021 at 11:15 AM at a single dose for COVID-19 immunization. Medical history included COPD (has it for lots of years) and nickel sensitivity. She does not have any reactions to her previous unspecified vaccines but had a normal reaction like sore arm. Concomitant medication included bimatoprost (LUMIGAN). The patient previously received flu vaccine and pneumonia vaccine, both for immunization in 2020 around the end of Sep or beginning of Oct. The patient reported side effects regarding the COVID vaccine and said she was a little confused and unsure if she was having a problem or if she should see a doctor. On 16Jan2021 at 11:15 AM, she had the first dose of the COVID vaccine and afterward she had a lot of effects which were mostly muscle and body aches in Jan2021. She also experienced some ongoing congestion in one nostril but saw this as just more congestion and that she was having to blow her nose more in Jan2021. She did the (app name) report but didn't report the stuffiness. She did report that in the first few days she felt like she was having the onset of pneumonia and felt tired and run down (Jan2021). Two days ago, she started feeling itchy (Jan2021) and she didn't know what it was, she didn't know if she ate something or what. Now she has developed a rash (Jan2021) which is ongoing until now. Her paperwork said the rash would happen right away if it was caused by the vaccine. The patient wanted to know if this is something she should be concerned about and if the rash could appear or started this long after she had the vaccine. Her second dose is due on 06Feb2021. The patient wanted to know if the vaccine contains nickel or any metal substances in it since she had compared her rash to her nickel sensitivity. The patient wanted to know if rash is a side effect from the vaccine and how long it will last. She didn't put rash down for the safety check either as she didn't know if it was caused by the vaccine. Today her rash, she is so itchy. She does have it on her neck and certain areas but not everywhere. It looks like what would happen after a bad fever. It is not raised but is like a fever type rash. She did note that she had an increase dose of a medication eye drops (Lumigan; Lot: T and a 0 or O followed by 544, and NDC: 0023320503. Expiry: Jan2022) around the time the rash started but after getting the vaccine. Her head, neck and back are very itchy. She mentioned that she waited 2 days and did not put this event in the (app name). She would have reported it yesterday, but she didn't get one yesterday. She also noted that it was very dry there and cold and a person is going to get dry skin. She does have an allergic to metal and wondered if that was in the product. In her neck area, it looks just like when she would wear a cheap necklace. No treatments received. The events did not require emergency room or physician office visit. The patient has no prior vaccination within four weeks. The patient had not yet recovered from events rash/like a fever type rash and congestion in one nostril/stuffiness; while unknown outcome for the remaining events.
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| 69 | 2021-02-07 | neck pain |
headache body chills body aches eye throbbing All symptoms were a milder version of what I experienc...
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headache body chills body aches eye throbbing All symptoms were a milder version of what I experienced when I had Covid -19 in NOvmeber 2020. I also had slight injection site pain that radiated to the left side of my neck
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| 69 | 2021-02-08 | muscle tightness |
Lot # EN6201 exp 2/13/2021 Approximately 30 seconds after pt received vaccination pt c/o her neck g...
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Lot # EN6201 exp 2/13/2021 Approximately 30 seconds after pt received vaccination pt c/o her neck glands "locking up." Described it as feeling a knot in her neck glands with pain. Pt states this has happened to her in the past and is unable to determine what causes it to happen. Also c/o mild headache and dizziness. Pt hasn't eaten yet today. Denies any respiratory issues. Episode lasted approximately 10 min then pt denied "tight neck glands" is now feeling fine. Was monitored for additional time in waiting area before going home in no apparent distress. 1028 BP 154/73, HR 86, 97% O2 sats on room air 1037 BP 156/66, HR 80, 97% o2 sats on room air
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| 69 | 2021-02-09 | joint pain |
This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A...
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This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (EL8982) via an unspecified route of administration on 21Jan2021 12:30 at single dose in left arm for COVID-19 immunisation. No additional vaccines administered on same date of Pfizer suspect. Medical history included COVID-19 virus from Jun2020 to an unknown date. There were no concomitant medications. The patient reported fever, joint pain and tiredness, experienced fever, cold and chills after the first dose, all on Jan2021. She was asking how long these symptoms usually persist. The patient received COVID shot last Thursday. Had chills, fever, ugly fever blisters, and fatigue. The patient asked how long does the fatigue stay in the system because she is really tired. She was tired since 22Jan2021. She had chills on the night of 22Jan2021. She is done with fever and chills, she is just tired. Had COVID-19 virus in Jun2020. Feel like she has it again. The temperature was 99 degrees, began on night of 22Jan2021. Fever blisters started on 23Jan2021 reported as are subsiding, but still present. She was still really tired. Woke up Saturday and thought she had COVID-19 virus all over again. The events did not require visit to AES, because she was ok. Event outcome of fever blisters was not recovered, while for others was unknown.
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| 69 | 2021-02-09 | back pain, neck pain |
Pain through back across both arms and neck.; A headache that feels like my heads going to explode.;...
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Pain through back across both arms and neck.; A headache that feels like my heads going to explode.; swell up like a balloon; Nauseated; Chills; fever; Pain on both my legs cannot walk; Pain through back across both arms and neck. Cannot lift my arms; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the right arm on 20Jan2021 16:00 at single dose for covid-19 immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing , hypersensitivity (Known allergies: Yes) from an unknown date and unknown if ongoing, covid-19 (if covid prior vaccination: Yes) from an unknown date and unknown if ongoing. Concomitant medications included unspecified medications. The patient experienced pain through back across both arms and neck, the patient cannot lift their arms. The patient also experienced pain on both their legs cannot walk, a headache that feels like their heads going to explode, nauseated all the time, swell up like a balloon, chills and fever. It was reported that the events occurred on 21Jan2021. Therapeutic measures were taken as a result of pain through back across both arms and neck. The patient did not recover from the events. Information on the lot/batch number has been requested.
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| 69 | 2021-02-09 | muscle pain |
Pain in the lower, inner aspect muscle of upper right arm. Radiants to muscle just below the elbow. ...
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Pain in the lower, inner aspect muscle of upper right arm. Radiants to muscle just below the elbow. Both muscles hurt when stretching or picking something, even the TV remote, up; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= EJ1686), via an unspecified route of administration at right arm on 19Jan2021 13:45 at single dose for covid-19 immunisation. Medical history included multiple sclerosis, hypertension. The patient received any other medications within 2 weeks of vaccination as prescribed. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021, The patient experienced pain in the lower, inner aspect muscle of upper right arm. Radiants to muscle just below the elbow. Both muscles hurt when stretching or picking something, even the TV remote, up. The patient was concerned she may drop something. It started day after having the shot and had been 4 days. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event was not recovered.
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| 69 | 2021-02-10 | back pain, musculoskeletal chest pain, neck pain, joint pain |
Beginning on January 15 and lasting for 18 days, I experienced confusion, extreme migraine-strength ...
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Beginning on January 15 and lasting for 18 days, I experienced confusion, extreme migraine-strength headaches, ripping pain in chest, ribs, upper back, shoulders, neck, head. I could not sit or lie down comfortably. I saw Dr. on February 1 who ordered a CT scan which was clear. He prescribed Prednisone and Robaxin 500 mg. I saw Dr. again on February 4 at which time most of the pain subsided but my body was very sore. It is now February 11 and I still feel a bit of cloudiness, but am much better. Hopefully, I'll feel like myself within a few days.
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| 69 | 2021-02-10 | muscular weakness |
2 days after vaccine developed weakness of legs then arms. MRI cervical and thoracic spine most con...
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2 days after vaccine developed weakness of legs then arms. MRI cervical and thoracic spine most consistent with Transverse Myelitis; Transverse Myelitis; This is a spontaneous report from a contactable physician. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at single dose for COVID-19 immunisation. The patient was not pregnant at Time of Vaccination. Facility type vaccine was Hospital. Medical history included hyperlipidemia, hypothyroid. The patient's concomitant medications were not reported. No Other vaccine in 4weeks. Days after vaccine on 22Jan20212, the patient developed weakness of legs then arms. MRI cervical and thoracic spine most consistent with Transverse Myelitis. AEs resulted in Hospitalization, Disability or permanent damage. The patient was recovering. IV steroids, physical therapy was received as Treatment. No covid prior vaccination. No covid tested post vaccination. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-02-10 | muscular weakness |
Community member stated had "left arm weakness." stated she usually had left arm weakness in the pa...
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Community member stated had "left arm weakness." stated she usually had left arm weakness in the past after her "brain surgery in 2017." At 1600 community member stated she felt better and wanted to go home. Observer RN noted weakness to left lower extremity as well and called Rapid Response Team at 1607. Community member remained responsive and alert and oriented x4, followed commands.
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| 69 | 2021-02-10 | muscle pain |
About 12 hours after I had severe chills and fever up to 102.2, muscle pains & very slight headache ...
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About 12 hours after I had severe chills and fever up to 102.2, muscle pains & very slight headache Symptoms lasted 24hours EXCEPT for a feeling in my head that I have had when getting off my antideprssant--sort of fuzzy/shaken feeling. Wondering if it's making my meds for that ineffective.
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| 69 | 2021-02-10 | neck pain, back pain, muscle pain |
deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache...
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deyhydration; sick; sinus tachycardia; diarrhea; Fever over 102 degrees Fahrenheit; chills; headache; body aches; fatigue; dizziness; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; Pfizer COVID-19 Vaccine on 12Jan2021 with immunosuppressant mesalamine; will fall asleep through the day for 3-4 hours at a time and she does not even nap usually; Muscle pain; Neck ache; Backache; Problems with walking; problems with balance; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3246), via an unspecified route of administration on the left arm on 12Jan2021 14:30 at a single dose for covid-19 immunization. Vaccine was not administered in a military facility. Medical history included ongoing ulcerative colitis, ongoing high cholesterol, ongoing high blood pressure, celiac disease from 2005 (this has been tested too many times to count and it has been negative since after initial diagnosis 2005), arthritis (all her life) ongoing, hip replacement surgeries first done in 2005; repair of same hip in 2015; other hip in 2017. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccines include Pneumonia Vaccine, Shingles Vaccine and Flu vaccines; all on an unspecified date for immunization. She never had adverse events with those. Ongoing concomitant medications included rosuvastatin (5 mg tablet) for high cholesterol, mesalamine (400 mg capsule) for ulcerative colitis and lisinopril from 2018 for high blood pressure. According to the patient, she knows that mesalamine is an immunosuppressant and anti-inflammatory to keep inflammation in the colon down. This consumer was administered her first dose of Pfizer COVID-19 Vaccine on 12Jan2021 14:30 with immunosuppressant mesalamine. The night of 14Jan2021 patient had headache, chills, body aches, diarrhea, fatigue, fever and dizziness like Covid 19 symptoms. She went to the ER during the past 11 days for IV fluids due to deyhydration from the diarrhea. Today, 25Jan2021 is the first day she has been out of the house, except to go to the ER, since she received her 1st vaccine dose. On Jan2021 muscle pain, neck ache, backache, problems with balance and problems with walking. Events probably started with intense diarrhea starting 14Jan2021; then Fever over 102 degrees Fahrenheit and chills 14Jan2021; Specific onset dates and onset times unknown otherwise other than between 14Jan2021 and 16Jan2021 onset dates. It was a rolling week of agony after that with one adverse event after another until she ended up in the emergency room on 16Jan2021 because she was so dehydrated and was really sick. She was not admitted to the hospital related to any of these events; but while in the emergency room she was given intravenous fluids; a chest x-ray; blood work; after maybe 5-6 hours she was sent home; she was also given a COVID test which was negative; and then 2 days later took another COVID test which was also negative. Both COVID tests were Rapid Tests: on 16Jan2021 and 18Jan2021. On the Chest xray they suggested she had some sinus tachycardia which is just a rapid heartbeat and not surprising; nothing else showed up on Chest x-ray; as far as anything else testing/results wise there was only some facetious blood work which they just said to follow-up with her PCP regarding but nothing really out of the ordinary. She can finally out of bed on a regular basis for a couple of hours daily; she is still very fatigued; she has no muscle pain, neck aches or body aches at this time; she does not have the strength she should have; is no longer experiencing headaches or fever; but is extremely tired. She will fall asleep through the day for 3-4 hours at a time and she does not even nap usually (Jan2021). She has not driven yet but assumes probably once she is a little stronger she will be able to drive again. She did not have upper respiratory, chest or cough issues. The outcome of the events fever, headache, body ache, muscle pain, neck ache was recovered on Jan2021; fatigue was not recovered. The outcome for the other events was unknown.
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| 69 | 2021-02-11 | limb discomfort |
approx 24 hrs after 2nd dose vaccine-- extreme pain, entire legs (both), felt very heavy and like ha...
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approx 24 hrs after 2nd dose vaccine-- extreme pain, entire legs (both), felt very heavy and like hamstrings were "pulled" and shins and ankles in pain as well. In addition, overall body fatigue, feeling exhausted. All symptoms continued for approx 36 hours, gradually ending after 48 hours
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| 69 | 2021-02-12 | muscle pain, joint pain | Coughing, severe headache, muscle pain through out back arm and hip area |
| 69 | 2021-02-12 | muscle pain | Chills, fever, headache, muscle ache, tiredness, swollen lymph nodes, sore throat, caugh |
| 69 | 2021-02-13 | joint pain, muscular weakness | 104.5 degree fever, rigors, hallucinations, severe joint pain, headache, muscle weakness |
| 69 | 2021-02-13 | muscle pain |
Severe muscle pain, severe weakness, slight shortness of breath. Was unable to sleep because of sev...
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Severe muscle pain, severe weakness, slight shortness of breath. Was unable to sleep because of severe muscle pain. I passed out when I went to the bathroom at 3:53 am from the pain I came to on the floor at approximately 3:57 and had hit my head just below my eyebrow on the sink counter. I was bleeding from a wound and sustained a black eye.
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| 69 | 2021-02-14 | joint pain |
Triggered an Auto immune flair up response I get with Sjogrens syndrome..Generalize muscle and joint...
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Triggered an Auto immune flair up response I get with Sjogrens syndrome..Generalize muscle and joint pain, Extremely dry eyes, mouth. Fatigue. Dizziness. Diarrhea. from 1/29/2021 to 1/31/3021
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| 69 | 2021-02-14 | back pain, musculoskeletal discomfort |
5:30pm: hands and feet felt very cold. Mild chills began. 6:10pm: temp was 98.3F Bundled up on the c...
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5:30pm: hands and feet felt very cold. Mild chills began. 6:10pm: temp was 98.3F Bundled up on the couch - socks, boots, leggings, sweatshirt, 2 blankets - and napped. 9:00pm; finally felt warm. Back and shoulder muscles were very sore. Temp had risen to 100.3F. Took 400mg ibuprofen and went to bed. Awoke the next morning feeling great. No residual effects.
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| 69 | 2021-02-15 | joint pain |
Developed fever, fatigue, extreme joint pain, HA, ear ache, tachycardia, SOB. Had Covid 11/4, and t...
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Developed fever, fatigue, extreme joint pain, HA, ear ache, tachycardia, SOB. Had Covid 11/4, and these are all symptoms that she had when she had Covid. Continues with HA, ear ache, joint pain, fatigue and SOB today. MD has not responded yet.
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| 69 | 2021-02-15 | arthritis |
HEADACHE, NAUSEA, JOINT INFLAMMATION, EXCESSIVE NASAL MUCOUS DRAINAGE, DISORIENTATION, DIZZINESS, HY...
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HEADACHE, NAUSEA, JOINT INFLAMMATION, EXCESSIVE NASAL MUCOUS DRAINAGE, DISORIENTATION, DIZZINESS, HYPERSENSITIVITY TO LIGHT AND NOISE, LACK OF URINATION, BOUTS OF DIARREAH, CHILLS WITH SKIN ICE COLD TO TOUCH, FREEZING FEET, UNABLE TO DRINK LIQUIDS; COULD NOT EAT FOR 3 DAYS; NO FEVER
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| 69 | 2021-02-17 | muscle pain, neck pain, joint pain |
Swelling of Lymph on the left side of bottom of neck within a half hour. Then in evening of that day...
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Swelling of Lymph on the left side of bottom of neck within a half hour. Then in evening of that day, swelling of face, eye lids, lips with tingling, hands, feet, tiredness, headache, muscle pain, neck pain real bad on the left side more, joint pain, feeling unwell, brain fog, dizziness, weakness, difficulty breathing at times. This lasted for 3 days, and after 15 days I now have Pink eye, swelling in hands yet and breathing is short at times.
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| 69 | 2021-02-17 | neck pain, back pain, joint pain |
Sore arm; neck pain; radiated to shoulder; radiated to back toward backbone, then up back; headache;...
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Sore arm; neck pain; radiated to shoulder; radiated to back toward backbone, then up back; headache; This is a spontaneous report from a contactable consumer reporting for herself. A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9263 and expiry date unknown) on 26Jan2021 18:00 at single does via an unspecified route of administration into her left arm for COVID-19 immunization. Medical history included Lupus, Lyme disease, hypothyroid, Meniere's, and sulfa allergies. The patient had not had COVID prior the vaccination, COVID not tested post the vaccination. Concomitant medication included levothyroxine (LEVOTHYROXINE), acyclovir (ACYCLOVIR), ezetimibe (EZETIMIBE), hydroxychloroquine (HYDROXYCHLOROQUINE). No other vaccine received in four weeks. The patient experienced adverse events from 20:00 on 26Jan2021. She experienced sore arm, radiated to shoulder, then to back toward backbone, then up back and side of neck. It's very painful. On 07Feb2021 ("today"), her neck pain was better but she had a headache. These events took place ongoing for several days after and since she had the vaccine. It was reported that the events resulted in Disability or permanent damage. The patient did not receive treatment for the events. The outcome of the events was provided as recovering.
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| 69 | 2021-02-19 | back pain, musculoskeletal stiffness, neck pain |
I woke up early the following morning after the vaccine with pain and stiffness in my head, neck and...
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I woke up early the following morning after the vaccine with pain and stiffness in my head, neck and upper body especially upper back. I also had headaches. The pain and stiffness increased over the following several days. The pain and stiffness progressed to severly limit my range of motion in my head, neck and upper body. These symptoms have persisted for 7 days and now at day #8 are gradually decreasing. As of today, day 9, I still have some pain and stiffness. I was given the Pfizer Covid 19 Vaccine. Question 22. I have not received any vaccines one month prior to date listed.
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| 69 | 2021-02-19 | muscle pain |
Around 4 am on 2/19/2021 woke with a pressure in mid abdomen. Had watery diarrhea approximately a g...
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Around 4 am on 2/19/2021 woke with a pressure in mid abdomen. Had watery diarrhea approximately a gallon, then vomited short time later. have had low grade fever 99.8 and chills. muscle aches. Have not been able to eat although could sip water. Still every few hours have had watery diarrhea. Not sure if this is related to the vaccine because of the GI nature. I suppose it could be food poisoning from eating Tyson frozen chicken product evening before for dinner. Obviously cooked. I rarely get sick with colds or GI symptoms. so that this occurred so close to vaccine reception wanted to report.
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| 69 | 2021-02-20 | joint pain, muscle pain | Excruciating headache, weakness, fatigue, nausea, muscle and joint pain |
| 69 | 2021-02-20 | musculoskeletal discomfort, back pain |
5 hr after second shot ate dinner and had diarrhea. Felt ok and then went to bed. 1 AM awoke with st...
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5 hr after second shot ate dinner and had diarrhea. Felt ok and then went to bed. 1 AM awoke with stomach and back aching and cramping. Unable to find comfortable position. Nothing warranting intervention but clearly too uncomfortable to sleep. Some tingling on back of arms and thighs; similar to flu. May have slept briefly and woke saturday to similar tummy pain. No diarrhea or vomiting. Slight headache. Symptoms began to disappear soon with stomach ache dissipating throughout day. Able to sleep fine saturday night and 100 percent good today. Almost no symptoms after shot one; by the way.
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| 69 | 2021-02-20 | musculoskeletal stiffness | redness of face neck trunk arms, itching, itching eyes and throat, stiff neck |
| 69 | 2021-02-20 | muscle pain |
Sore arm started on 2/19/21 in morning, later in evening about6 pm chills and muscle pain,headache,...
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Sore arm started on 2/19/21 in morning, later in evening about6 pm chills and muscle pain,headache, tiredness.
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| 69 | 2021-02-21 | muscular weakness |
After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this ...
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After my vaccine, I had problems breathing for about 5-10 minutes. My symptoms were different this past two weeks. I experienced nausea, dizziness, felt like my brain was on fire. Last week I could not comprehend what people were saying, I did not understand. Extreme irritation, anxiety, depression. Fatigue and tiredness, my legs are weak. My blood pressure went skyrocketed: 169/80.
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| 69 | 2021-02-23 | muscle pain, joint pain | Over 2 days had severe joint and muscle aches in knees and back. Fatigue. Slight fever and chills. |
| 69 | 2021-02-23 | muscle pain |
Chills; Fever of 100.2; Headache; Muscle ache; This is a spontaneous report from a contactable consu...
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Chills; Fever of 100.2; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 13:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 26Mar2020, she tested positive for Covid. In the beginning of May2020, she went to get tested for antibodies, she did have them, that she received a report, number was 8.2 and knows that at 1.4 she would be considered to have antibodies so they told her it was good that her number was high, she asked them what it meant and they told her they did not know. Patient had chills, fever of 100.2, bad headache, and muscle aches on 20Jan2021. She took Tylenol to treat her symptoms and they went away, and states they would come back as Tylenol wore off. Her symptoms have completely resolved however she does not have the exact date. Outcome of the events was recovered on Jan2021. Information about lot/batch number has been requested.
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| 69 | 2021-02-23 | muscle pain |
The itching was located just below the injection site at a spot where the skin was a little red; The...
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The itching was located just below the injection site at a spot where the skin was a little red; The itching was located just below the injection site at a spot where the skin was a little red; terrible itching in her left arm; out of balance, her balance was messed up; nervous; Sweaty; Feeling hot; felt like her heart was racing fast; felt dizzy/terrible lightheadedness; Feeling anxious; trouble sleeping; sharp pain in her muscle; This is a spontaneous report from a Pfizer-sponsored program. A contactable other health care professional reported that a 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot EL9263) via an unspecified route of administration at arm left on 24Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included drug allergies, IV contrast reaction. The concomitant medication was not reported. It was reported patient got the Pfizer COVID 19 vaccine Sunday 24Jan2021 at 13: 00PM in the left arm. She was scheduled for the second dose of the vaccine 16Feb2021. she got the vaccine and was perfectly fine; she started the wait time of 45 minutes and about 10 minutes into it she got really hot and felt like her heart was racing fast; felt dizzy on 24Jan2021. A nurse practitioner and a doctor came over and sat with her; she got some water and she was okay. They thought it was anxiety related to coming into a crowd, but for the next 36 hours she continued to feel anxious and on edge; she felt like she had too much caffeine. That night she had trouble sleeping; she had sharp pain in her muscles on 24Jan2021, it would be in one of her thighs then the other one. This was about 12 hours after the vaccine. States she took some tylenol and it did help. Adds she just continued to feel anxious and she was sweaty. States she has never has anything like this before. Today she felt perfectly fine; all of her symptoms had resolved. Then today, when she was driving to a routine GYN exam and she experienced a terrible itching on her left arm on 24Jan2021. It was sudden and startled her. The itching was located just below the injection site at a spot where the skin was a little red, feathery red, just below the injection site. Now the itching has stopped but it is still red. she couldn't hardly feel it being injected, she doesn't usually have reactions to vaccines, she never had anything, but she has a few drug allergies, and she was separated out, she was flagged to wait 45 minutes after, instead of the 15. She does have an IV contrast reaction, and some other things, nothing she knew was in the vaccine, she was fine and wasn't worried that she was aware of. She thinks she got too hot, she had on a coat, she was sitting and panning through stuff, reading on her phone, and all of a sudden she had terrible lightheadedness, she never fainted in her life, she is pretty sturdy, she didn't know what to think, she was lightheaded, and it was not vertigo, not like the room was flying, but she was like out of balance, her balance was messed up, and she sat there a minute, she was too hot, she got out of her coat, and it got worse, she could feel her heart racing, and she was talking to herself, she thinks she nervous, she could feel her heart pounding, and was instructed to raise her hand if she had issues, so she raised her hand, a nurse practitioner came over, she raised her hand, and the doctor making rounds came over and he said take off your mask off, she did, that helped somewhat, it was that blasted mask, she couldn't get enough air, he gave her water, she thinks she got too hot and perhaps got nervous and didn't think she was she said she's not been around people, and was suddenly in a huge crowd, everyone was appropriately distanced, it was an extreme presentation, after 5-6 minutes, she was good, it went away, but for 36 hours she didn't feel right, she could feel sometimes her balance wasn't right, she was just not herself, she could do her usual, she lives on a farm, she did usual farm stuff, but was not herself, and in the night, she woke several times, her heart was beating too fast, too much, but she went back to sleep, and she told her son, she said it felt like she had had 4-5 cups of really strong coffee. So the next day she was ok. Absolutely her normal, and then she didn't think anything about it, and was driving to a routine GYN exam, which was canceled last moment due to an emergency, she was driving and suddenly her arm started itching, this was Tuesday, so 48 hours after, not the site, it was distal, underneath it, maybe 2-3 inches under injection site. The site did nothing, she looked that night, no redness, lump, no raised area, no warmth, nothing, but then she had itching, intense itching like poison ivy, and she scratched and thought wait a minute, at her appointment she looked at her arm, this area was 3-4inches under the site, that was red, feathery looking and flat, macular, not raised, no induration, no warmth, no lump, no pain, it was feathery dusty red and the next day it was gone, she did nothing to it, she thought to put hydrocortisone, and looked at it, but it was so faint and wasn't itching. The seriousness was reported as non-serious. The outcome of the events was Feeling hot was recovered on 24Jan2021; Heart rate increased; felt dizzy; Muscle pain; Sweaty was recovered on 25Jan2021; Feeling anxious was recovered on 26Jan2021; Vaccination site rash; Vaccination site erythema recovered in 2021. Vaccination site pruritus was recovering; Difficulty sleeping; Loss of balance, Nervous was unknown.
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| 69 | 2021-02-24 | joint swelling, joint pain, muscle pain |
Racing heart for about 8 hours Diarrhea for 3 days Fatigue for 5 days Headache for 5 days Nausea for...
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Racing heart for about 8 hours Diarrhea for 3 days Fatigue for 5 days Headache for 5 days Nausea for 3 days Muscle pain for 2 days Joint pain (right knee swollen and painful) for 2 days UTI started 4 days after vaccine
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| 69 | 2021-02-24 | joint swelling, muscle pain |
2 hours after injection left leg from the knee down started to swell and the muscle turned rock hard...
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2 hours after injection left leg from the knee down started to swell and the muscle turned rock hard Severe pain made it impossible to walk The swelling is not going down and is causing great discomfort went to the doctor yesterday and it was determined there is a blot clot
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| 69 | 2021-02-25 | joint pain, muscle pain |
Developed fever of 101 degrees, shaking chills, joint and muscle pain, extreme fatigue, lack of appe...
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Developed fever of 101 degrees, shaking chills, joint and muscle pain, extreme fatigue, lack of appetite, which persisted for about 24 hours. Low grade fever present Day 2 after vaccine administered.
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| 69 | 2021-02-25 | joint pain, muscle pain |
Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep th...
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Beginning @ 8 hours following second dose, full range of side effects began, preventing any sleep that night, and continuing throughout the entire next day and night (02/24/2021), finally subsiding over the course of the next day (02/25/2021). Side effects included: Injection Site Pain; Tiredness; (raging) Headache; Muscle pain; Chills; Joint pain; What felt like fever (in between shuddering chills) - not evident in temperature; Nausea (non-productive); Feeling unwell; (tender) Lymph nodes. Debilitating and confusing. Glad to have received the vaccine in any case (small price to pay).
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| 69 | 2021-02-25 | joint pain | 2 days after vaccine started with rash, body aches, joint pain. Treated but continues |
| 69 | 2021-02-25 | back pain, armpit pain |
Started with headache and tired, then chills, then left breast itchy, then arm and armpit became sor...
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Started with headache and tired, then chills, then left breast itchy, then arm and armpit became sore, body aches and backache all night. I took Bismuth 525mg at 9am, acetaminophen 1000mg at 11am, felt better for a few hours, took acetaminophen 500mg at 6pm.
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| 69 | 2021-02-25 | limb discomfort |
Was nauseated for a while in bed. Went to bathroom to look for Phenergan. Started to pass out. Ly...
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Was nauseated for a while in bed. Went to bathroom to look for Phenergan. Started to pass out. Lying on floor with dry heaves. Took Phenergan and went to sleep. Next day at 2 PM still dizzy. Pulse 64 sitting. 110 standing. B/P 84/40 standing.
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| 69 | 2021-02-25 | musculoskeletal discomfort |
Immediately following administration of the patient's second dose, the patient reported feeling "pul...
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Immediately following administration of the patient's second dose, the patient reported feeling "pulsation up to her neck". Vitals checked with HR in 160?s, BP 116/80, pulse 96. Denied chest pain, nausea, SOB and all other major symptoms. Tried vagal maneuvers, HR remained elevated. Called EMS.
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| 69 | 2021-02-26 | joint pain | ACHY ARM; JOINT PAIN; HEADACHE; FATIGUE; DIARRHEA |
| 69 | 2021-02-26 | arthritis, muscle pain, joint pain |
I have arthritis and the shot seems to have made the pain worse and has lasted about 4 days. Joint ...
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I have arthritis and the shot seems to have made the pain worse and has lasted about 4 days. Joint and muscle pain
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| 69 | 2021-02-28 | joint pain, muscle pain |
Day1- headache in nasal sinus area and between eyes, Day 2- muscle aches, joint pain, dizziness, nau...
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Day1- headache in nasal sinus area and between eyes, Day 2- muscle aches, joint pain, dizziness, nausea, lack of appetite. That evening, awoke out of sleep at 3 am with extreme abdominal pain, walked to bathroom and almost passed out, had to lay on the floor for 15 minutes.. After a half our it happened again. No diarrrhea but had 2 soft formed stools (very unusual for me). A lot of nausea, weakness and abdominal pain. Chills for 2 days.
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| 69 | 2021-02-28 | muscle pain |
At time of vaccine on , had a fishy/metal taste in her mouth, which lasted till bedtime. First day,...
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At time of vaccine on , had a fishy/metal taste in her mouth, which lasted till bedtime. First day, arm was sore, not red or swollen. Next few days had severe fatigue, muscle pain, swollen lymph nodes in neck. Next day, 2/13after vaccine when woke up, had a white coated tongue which lasted one day. That evening, her tongue swelled up which lasted about a week. Pt saw doctor at medical center on Feb 15. He advised you to take Tylenol and 2 benedryl day of vaccine and he wrote her a script for an EPI pen for after the vaccine and to use as needed.
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| 69 | 2021-03-01 | joint pain |
1st shot = only tender at injection site but remains tender. 2nd shot = 1 hr after injection: feelin...
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1st shot = only tender at injection site but remains tender. 2nd shot = 1 hr after injection: feelings of fatigue, soreness at injection site with swelling, slight throbbing in back of head/neck, later in PM ate late lunch Big Mac meal around 3:00 but not hungry though had no breakfast, aching in knee and hips began to become constant with movement. Slept a couple of hours and began to feel chilled to bone rest of evening, headache continued, thirst and frequent urination (1 1l2 hr apart), had stopped all medication to allow shot to work. Friday late evening early Saturday Am chill became violent in shakes used blankets/plastic sheets/socks to get warm. Slept in 2 hrs increments all night. Saturday sipped fluids
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| 69 | 2021-03-01 | muscle pain |
Injection site pain; tiredness; muscle pain; chills; swollen lymph nodes. Symptoms started three hou...
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Injection site pain; tiredness; muscle pain; chills; swollen lymph nodes. Symptoms started three hours after injection and lasted a day and a half, except swollen lymph nodes and injection site pain that lasted a couple of days longer. Patient took acetaminophen and symptoms resolved without further treatment.
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| 69 | 2021-03-02 | joint pain |
eczema flare up, skin red, her left anterior chest was burning and itchy, skin pain; headache; on ea...
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eczema flare up, skin red, her left anterior chest was burning and itchy, skin pain; headache; on early Friday evening she ended up with joint pain that was so bad, she thought she was going to die. She said her wrist, elbows, fingers, hips, knees, every joint down to her ankles, hurt; This is a spontaneous report from a contactable nurse (patient; retired nurse) via a Pfizer-sponsored program. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6201), via an unspecified route of administration in the right deltoid on 10Feb2021 at 12:35 PM (at age of 69 years old) at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a convention center. The patient's medical history included eczema from 24Dec2018 and ongoing, rosacea (developed Rosacea at 65 years old), and the patient also reported that she used to be 5'4" and she lost 2 inches. She said she had a bone density test recently and was told she is 5'2". She said she objected to the measurement of 5'2", so the nurse told her to stand as tall as she can, and then the nurse noted her height as 5'2-1/2". There were no concomitant medications. There were no additional vaccines administered on same date of BNT162B2. The patient had no prior vaccinations within 4 weeks. On 12Feb2021, the patient experienced eczema flare up, skin red, her left anterior chest was burning and itchy, headache, skin pain, and "joint pain that was so bad, she thought she was going to die. She said her wrist, elbows. fingers, hips, knees, every joint down to her ankles, hurt". The patient said she received her first COVID-19 Vaccine on 10Feb2021. She said everything was fine after she received her COVID-19 Vaccine. She didn't even have a mark on her arm where she received the COVID-19 Vaccine. The patient reported that she got the first dose of the COVID-19 vaccine on 10Feb2021 and is due to the second dose on 03Mar2021. Approximately 2 and half days later she got an eczema flare that was quite severe out of the blue since she was having eczema diagnosed since she was 67 (as reported; she is 69 today). She still has some itching and burning and she wondered if this was something that has been reported also for other psoriasis/eczema patients. She was concerned about taking the second dose since she thinks this may be caused by the vaccine as she stated that nothing has changed in her life aside the vaccination. The patient reported she takes tacrolimus for the treatment of her eczema. Also she said that she had some joint pain for a couple of days. She said 2-1/2 days later (Friday, 12Feb2021), out of the blue, she had an eczema flare up. She said she was diagnosed with eczema at 67 years old. She said Friday night (12Feb2021) into Saturday (13Feb2021) her left anterior chest was burning and itchy. She clarified her skin was really red and angry looking, and painful. She said she has not had any pain with her eczema in a long time. She said she took topical ointments and medication for the eczema flare up. She said she was surprised at the intensity of her eczema flare up. She clarified her initial diagnosis for eczema was on her left anterior chest and bra strap area, and arms. She said she has never had eczema on her face or any other part of her body. She said she was totally asymptomatic prior to getting her first COVID-19 Vaccine. She said on early Friday evening (12Feb2021) she ended up with joint pain that was so bad, she thought she was going to die. She said her wrist, elbows, fingers, hips, knees, every joint down to her ankles, hurt. She said she had a headache. She said by Sunday (14Feb2021) her joint pain and headache were gone. She said her symptoms went away so quickly. The patient asked if people reported a flare up with psoriasis or eczema after getting the COVID-19 Vaccine and if should she have any concerns about getting the second COVID-19 Vaccine shot on 03Mar2021. The patient her eczema treatment included a combination of oral and topical medications. She clarified she used more of the prescription topical lotion than the over-the-counter oral medications. She received Famotidine 10mg (clarified as Pepcid AC; NDC Number: 11673-031-65, Lot Number: OFE2821, Expiration Date: Feb2022). Her doctor told her she could take up to 20mg of Famotidine if her symptoms were bad. She said on Friday (12Feb2021) and Saturday (13Feb2021) she took 20mg of the Famotidine until she felt her symptoms were under control. The patient also received cetirizine 10 mg (reported as generic Zyrtec; NDC Number: 11673-502-87, Lot Number: 8ME2877A, Expiration Date: Sep2022). The patient reported that she took 20mg of the generic Zyrtec for the itching. She said her doctor told her she can take up to 20mg of the generic Zyrtec, if needed for itching. She said otherwise, she would normally take 10mg generic Zyrtec, as needed. The patient also received Tacrolimus Ointment 0.1% (Protopic Ointment; NDC Number: 0168-0416-30, Lot Number: JZ8459, Expiration Date: Apr2021), applied to affected areas twice a day and Triamcinolone Acetonide Cream, 0.1% (she stated she refers to it as "TAC" Cream; NDC Number: 67877-251-80, Lot Number: Y064, Expiration Date: Oct2022). The patient reported that she uses the "TAC" Cream under her breasts where her bra sits because the "TAC" Cream is less expensive than the Tacrolimus Ointment 0.1%. She said she uses the "TAC" Cream as needed, and the "TAC" Cream keeps her skin hydrated. She said she used the Protopic Ointment (Tacrolimus Ointment 0.1%) on Friday (12Feb2021), and then switched to the "TAC" Cream. The patient has had no itching or pain since early Monday (15Feb2021). Her joint pain and headache treatment included Advil Liquid Gel 200mg (UPC Number: 305730169080, Lot Number: 56264, Expiration Date: Jun2023). She said she took a couple Advil Liquid Gels on Friday (12Feb2021). The patient reported that she switched from Tylenol to Motrin because the Motrin worked well. She clarified she meant Ibuprofen when she said Motrin. She said she calls everything Motrin when she is referring to Ibuprofen. She said she took Tylenol occasionally and never felt the Tylenol worked. She said she hasn't taken Tylenol in a long time. She said Tylenol didn't work as well as the NSAIDs. She did not have the Tylenol NDC, Lot, and Expiration Date. The patient reported that she takes Bufferin Brand Aspirin normally for pain. She said she sees someone who treats her holistically, and that person recommended the Bufferin Aspirin because it was not as damaging to the body. She said since the Bufferin Aspirin takes longer to work, she took the Advil Liquid Gel for faster pain relief. No further details provided. The events eczema flare up, skin burning sensation, skin red, skin pain, joint pain, and headache were reported as serious - medically significant. The patient reported that she felt her symptoms were medically significant because her eczema flare up was so different from what she has ever experienced before. She said nothing had changed in her routine, and she has been in control of her eczema. She said she has had only very minor eczema flare ups. The events did not require a visit to emergency room and to physician office. The outcome of the events eczema flare up and skin red was recovering. The outcome of the events headache and joint pain was recovered on 14Feb2021. The outcome of the events skin burning sensation, skin pain, and itchy skin was recovered on 15Feb2021. The events eczema flare up, skin burning sensation, itchy skin, skin red, skin pain, joint pain, and headache were assessed by the (patient) as related to BNT162B2.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-03-02 | musculoskeletal stiffness | Woke up day after vaccination, left arm very sore ,stiff with significant swelling |
| 69 | 2021-03-03 | joint pain, muscle pain |
Muscle pain, joint pain, chills, fever, and pain at the injection site. overall feeling unwell. a li...
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Muscle pain, joint pain, chills, fever, and pain at the injection site. overall feeling unwell. a little swollen at the injection site.
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| 69 | 2021-03-03 | muscular weakness |
Patient had arm and leg weakness, fatigue, confusion, nausea, body aches that lasted about 48 hours ...
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Patient had arm and leg weakness, fatigue, confusion, nausea, body aches that lasted about 48 hours and are improving.
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| 69 | 2021-03-06 | joint pain, muscle pain, back pain |
Pain in my lower right side and back. Hives on my upper legs and upper arms. Purple spots on my shin...
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Pain in my lower right side and back. Hives on my upper legs and upper arms. Purple spots on my shins. Extreme fatigue resulting in shortness of breath when I walk a very short distance. Coughing up very small traces of blood. Muscle and joint pain. In particular sore abdomen, back and upper shoulders. Pain is sharp when I cough or move a certain way. Sometimes it is just a persistent aching.
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| 69 | 2021-03-06 | back pain, musculoskeletal discomfort, joint pain | severe lower back pain shoulder pain (both) neck discomfort slight headache |
| 69 | 2021-03-06 | back pain | patient became flushed, stated hard to breathe, headache, nausea and back ache |
| 69 | 2021-03-06 | muscle pain |
Around 1 am woke with chills, myalgia, fever to 100.5. Didn't take anti-pyretic. Slept on and off. A...
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Around 1 am woke with chills, myalgia, fever to 100.5. Didn't take anti-pyretic. Slept on and off. At around 3am woke up. Walked to bathroom to urinate. Stood up, started severe nausea and retching. The next thing I remember is finding myself on the ground in the bathroom, retching into the shower area. Called my husband (we are both physicians). My shirt was completely drenched. I was unable to stand up for 5-10 minutes. He noted a 6" hole in the wall (completely through the sheetrock) behind me. I had no memory (and still don't) or falling or hitting my head. He walked me back to bed. My BP was 110/65, pulse was around 70, pulse ox was normal. Continued retching not as severe. Took one Zofran. Eventually fell asleep. In the morning noticed a painful area at the left posterior part of my scalp. There were flakes of sheetrock there. The next day I was tired, felt slightly off balance, otherwise ok. Feeling of vague fuzziness, off-balance continued for a few days, then resolved.
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| 69 | 2021-03-07 | joint pain, back pain |
My second COVID-19 vaccination injection on Friday morning, 2/19/2021 resulted initially (starting o...
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My second COVID-19 vaccination injection on Friday morning, 2/19/2021 resulted initially (starting on Saturday, the day following the vaccination} in a sore right wrist and a much more painful right arm that steadily grew in intensity and spread rather rapidly into my upper torso. By the following day (Sunday, 2/21) my breasts became very sensitive and I had severe pains across my back. This may or may not have been the beginning of a banding type MS exacerbation, but by Monday, 2/22, it was clear that I was experiencing a full-blown and seriously disabling exacerbation. Both legs experienced the tingling and numbness I have had in a prior exacerbation, and by the time I was able to talk to Dr. (my neurologist) on Monday afternoon (2/22), the numbness had progressed upward into my lower abdomen and I was no longer able to stand at all. It appears highly likely that the MS attack was triggered by the response of my immune system's reacting to the discomfort and severe body pains that occurred following the vaccination. I told Dr. of the total loss of feeling and use of both legs and was experiencing a increasing numbness from toes up to abdomen. Before ordering the high doses of corticosteroids used to stop my exacerbation, Dr. sent me to the Emergency Room for testing to make sure I did not have an infection that could be covered up by the steroids. When this testing did not show any such infection, the ER administered an IV infusion of 1 gram of solumedrol, followed by gradually decreasing high oral doses of prednisone. As of this date, numbness has started decreasing and some limited utility of right leg has returned. Still i can no longer stand and perform even the minimal movements to-and-from wheelchair to bed or toilet without substantial physical help (not needed before this exacerbation) from my sole caregiver, my husband.
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| 69 | 2021-03-07 | limb discomfort |
I'm not sure this was from the vaccine, but it seems like the only likely cause: I had Pfizer Shot#2...
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I'm not sure this was from the vaccine, but it seems like the only likely cause: I had Pfizer Shot#2 on 2/23/21. I was feeling great for an entire week. Then, a week after the second shot, I got the worst fatigue I can ever remember, except maybe when I was pregnant, starting the evening of March 1. When I awoke on March 2, my body aches were so intense, I felt like I couldn't move out of bed. Then during the day, I tried to take my usual outdoor walk - usually ~ 5 miles/day. I had to turn around part-way because I was so exhausted and my legs felt both like concrete and like they were quaking from tiredness. Later that afternoon, I fell asleep sitting up in my chair SIX times, even though I almost NEVER take a nap! I kept doubting myself because I haven't read about delayed onset of symptoms, but we don't go anywhere indoors at all except for getting the shot at the pharmacy and an MD clinic appointment now and then. (I did have an annual MD appointment on March 2, so was in the clinic that very day, using all precautions. I don't imagine I could have gotten ill instantly from something at the clinic though?) In ensuing days, I continued to feel super-fatigued, but have had more energy each day, to the point where, now, 6 days later, I feel "almost" like myself. I'm still unsure of walking the full 5 miles without getting too tired, and certain body aches are still hanging on (knee, wrists, fingers), but I'm otherwise feeling good. If I had the symptoms right after the shot, I would have been sure it was from the shot, but since it was delayed a week, I was uneasy and it felt a bit scary because I felt so unlike my healthy, spry, active, motivated self. One other odd thing, that may be totally unrelated, but just in case - on the very day of the second shot, I got a huge stye on my left eye - something I haven't had in decades. It has still not gone away after 2 weeks. Just in case you get other reports, I am letting you know about this as well. The fatigue and body aches sound a lot like what is to be expected after the shot, but I do know there have been some eye-related issues as well.
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| 69 | 2021-03-07 | muscle pain | 103 fever Chills Muscle/body aches Extreme tiredness |
| 69 | 2021-03-07 | neck pain, back pain |
Experienced severe chest pain Severe migraine Pain in neck and back. Took ambulance to hospital B...
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Experienced severe chest pain Severe migraine Pain in neck and back. Took ambulance to hospital Blood pressure was extremely high
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| 69 | 2021-03-07 | neck pain | Headache, neck ache, nausea, chills, heartburn.. |
| 69 | 2021-03-08 | bone pain |
Strong allergy symptoms. Heavy nose drainage and aching eyes/cheekbones. Lasted one day took Benadry...
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Strong allergy symptoms. Heavy nose drainage and aching eyes/cheekbones. Lasted one day took Benadryl and slept.
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| 69 | 2021-03-08 | limb discomfort |
Very sore arm starting about 4 ours post injection. Couldn't raise it above shoulder level. Felt v...
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Very sore arm starting about 4 ours post injection. Couldn't raise it above shoulder level. Felt very thick and heavy. Throbbing. Pulsating, as though I could feel my heartbeat in my arm when I went to bed. Took to Tylenol or sleep would have been impossible. Woke up to a less painful arm and it improved throughout day feeling almost normal by bedtime 24 hours later. Took 2 Tylenol to ensure sleep. Woke up Tuesday morning and arm felt almost 2100% normal. I thought, wow, that wasn't so bad. BUT I WAS WRONG. Tuesday mid morning, I began to feel what I would describe as jittery. Around 11:00 am a wave of nausea washed over me and subsided. I thought maybe I needed to eat as I hadn't yet so I had lunch. After lunch I began to feel nauseous again and like diarrhea was coming. After going to the bathroom, the nausea started building again, and the diarrhea recurred, and the nausea heightened. By mid afternoon I was on the floor hugging the toilet bowl wanting to vomit, waiting to vomit, groaning. It's been years since I've had nausea or vomiting and the whole experience was unexpected from what I read about possible reactions. I wondered if it was food poisoning but my husband and I had eaten the same thing and he was fine. Finally about 3:30-4:00, 48 ours post vaccine, I threw up multiple times, perhaps 5 times. After about 4:30 pm it was over. I was worried that if I ate again I'd be sick so I only drank decaf tea. I felt exhausted from the ordeal but very wired and jittery too. I crawled into bed hoping for sleep. No luck. At 3:00 am I was still watching the clock and shocked that I couldn't sleep. I had to get up at 6:30 in the morning due to some construction at our home. I was legit exhausted Wednesday. I no recurrence of the nausea or diarrhea after the bout on Tuesday afternoon. I ate modestly but normally on Wednesday and slept normally Wednesday night. Nothing more to report, although I read that up to a week later some people experienced a reaction so I wanted to give it a week to see if anything else would happen. Nothing else to report.
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| 69 | 2021-03-09 | joint pain |
Shoulder was a little sore; Arm soreness; itchiness, a rash, and a big area of redness on her left a...
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Shoulder was a little sore; Arm soreness; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A 69-year-old female patient (wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number reported as "ELI283 or EL1283"), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure (abnormal) and cholesterol (abnormal). Concomitant medications included blood pressure medication and cholesterol. The consumer was reporting on behalf of his 69 year old wife. She received the first dose of the BNT162B2 vaccine on 30Jan2021. On 06Feb2021, she started to experience itchiness, a rash, and a big area of redness on her left arm which was the injection arm. He stated he heard that the second dose can cause more side effects and he stated they both experienced arm soreness after the first dose on an unspecified date. Consumer stated, first of all thank you guys for making this vaccine. He and his wife received the vaccine (unspecified vaccine) their first dose last Saturday, a week ago yesterday and had no reaction to it at all, their shoulder was a little sore but that's it. Yesterday night, last night his wife noticed that the arm where she had the vaccination it has like a rash and he knows this online that Moderna has something called COVID arm but it doesn't say anything about Pfizer. He meant it's not to bother it itches a little bit you put some anti-itch cream on it wasn't a big deal. He was kind of concerned about the next you know they got the next one coming on the 18th, so, does she should change arm, do it on the other arm. Consumer added that that would be fine, he knows you guys want to know if there was any reaction so that you can log it in and that was basically why he called. They were going for their next shot they were going to the hospital and there were professionals there so pretty much ask them what they should do. Should they change arm or nothing to worry about if they do it again that was not the problem he just wanted to let you guys know that there was some kind of reaction a rash. Consumer stated he just put Cortaid cream on it and itch went away. The patient underwent lab tests and procedures which included lab work on 27Jan2021: doctor did for cholesterol, blood pressure reasons and everything was fine. The outcome was recovered for the event itchiness; and unknown for the rest of the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021170691 same reporter and drug, similar events, different patient
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| 69 | 2021-03-09 | joint pain |
Received COVID vaccine on 2-22-2021 an hour later started to have right arm pain at the site of the ...
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Received COVID vaccine on 2-22-2021 an hour later started to have right arm pain at the site of the injection. Since has had multiple issues and concerns, such as SOB, dizziness, joint and right arm pain, fatigue and nausea that started about an hour after receiving her vaccine. She said she has SOB at rest but with any type of exertion she is gasping for air. Rates her joint pain off the charts with walking and is bent over.
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| 69 | 2021-03-09 | muscle pain, bone pain |
Restless sleep, brain fog upon awakening, quite a bit of bone pain and muscular aches, fatigue . Las...
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Restless sleep, brain fog upon awakening, quite a bit of bone pain and muscular aches, fatigue . Lasted most of day after injection.
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| 69 | 2021-03-09 | muscle pain, neck pain |
Temp over 102 first night, over 100 second night, chills third night. Malaise, fatigue, difficulty c...
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Temp over 102 first night, over 100 second night, chills third night. Malaise, fatigue, difficulty concentrating Large muscle aches, pain in both sides of my neck Left arm red, hot, bruised Feels like the flu after 4 days
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| 69 | 2021-03-09 | neck pain |
AFTER RECEIVING PFIZER COVID-19 VACCINE #2, I EXPERIENCED "NORMAL" FLU-LIKE SYMPTOMS FIRST DAY AND 1...
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AFTER RECEIVING PFIZER COVID-19 VACCINE #2, I EXPERIENCED "NORMAL" FLU-LIKE SYMPTOMS FIRST DAY AND 1/2. ON SECOND DAY, AWOKE WITH SLIGHT HEADACHE AND SEVERE LEFT NECK PAIN, UNABLE TO MOVE HEAD FROM SIDE TO SIDE. FELT NAUSEAUS ON AND OFF ALL DAY. THE NEXT MORNING BEFORE WAKING, I COULD FEEL THE PAIN MOVING FROM THE LEFT TO THE RIGHT SIDE BEHIND MY NECK, FROM EAR TO EAR. THIS IS CONTINUING ON DAY 4 WITH NO RELIEF. CALLED MY PROVIDERS' OFFICE WHERE NURSE TOLD ME SHE HAD THE VERY SAME THING THAT LASTED 2 WEEKS, NECK PAIN PLUS FATIGUE. I HAVE NOT FOUND ANY INFORMATION RE. THIS SYMPTOM ONLINE.
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| 69 | 2021-03-10 | joint pain | 103+ fever, headache, joint pain, trouble breathing, Had sever case of covid 19 3/9/2020 |
| 69 | 2021-03-10 | joint pain |
02/11/2021 Noon - severe nausea 2200 - nausea resolved 2330 - extreme fatigue which continued throug...
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02/11/2021 Noon - severe nausea 2200 - nausea resolved 2330 - extreme fatigue which continued through 03/06/2021 then became moderate fatigue - continues to present. 02/12/2021 0030 - dry raspy cough - continues to present but lessened in intensity over time. HISTORY 01/2020 01/08/2020 - felt fine at movie theater, while walking to car swallowed & became aware that my throat was suddenly quite sore - difficult to swallow. Within 15min throat so sore could hardly swallow. Had start of dry cough. ON increased dry cough; HA; joint pain; sweats/chills; low grade fever. 01/10/2020 - HA resolved. Sore throat less painful; very uncomfortable dry cough. Extreme fatigue. 01/11-19/2020 - Due to fatigue, unable to be out of bed for more than a few minutes. Hydrating/soup. Couldn't carry on verbal conversation due to dry cough - no SOB if didn't try to talk. 01/20/2020 - Was able to get up & dressed; left house for short time. Felt better, cough less of problem but persisted. Took about 3-4 weeks to feel 100%. AN ASIDE My osteoarthritis pain, in left hip only, began to get much worse after 01/2020 episode. It took a quantum leap forward in pain again after 1st COVID-19 vaccination.
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| 69 | 2021-03-11 | muscle pain, joint pain | Muscle aches, joint pain, swollen lymph nodes in neck, chills, sore throat/tonsils/back of tongue |
| 69 | 2021-03-11 | muscle pain | Chills, fever, headache, tiredness, nausea, injection site pain, muscle pain |
| 69 | 2021-03-12 | joint pain |
Metalllic taste in mouth after 15 minutes; this went away after another 15 minutes. Later that even...
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Metalllic taste in mouth after 15 minutes; this went away after another 15 minutes. Later that evening, I developed severe pain in the right ankle, which went away by keeping weight off the ankle and was gone by the next day. About 24 hours after the injection, I developed severe pain in my right knee, which went away after a few hours by icing it for about 20 minutes every hour.
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| 69 | 2021-03-13 | joint pain, neck pain |
Very sharp pain about one inch below left collarbone, halfway between neck and shoulder. Remained no...
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Very sharp pain about one inch below left collarbone, halfway between neck and shoulder. Remained noticeable, and very sensitive to touch, for 8 hours. Gone the next morning. About 6 hours after injection had frequent need to clear my throat that occurred for about 3 hours.
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| 69 | 2021-03-14 | joint pain, joint swelling |
I had the normal headache, fatigue, and joint pain in my knees with the first and second dosage of P...
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I had the normal headache, fatigue, and joint pain in my knees with the first and second dosage of Pfizer. But something different occurred after the second dosage. I experience knee pain daily from surgery a few years ago. My right knee is always a bit swollen and painful. After the second dose of Pfizer, I experienced shooting pains in my knees, especially the right knee. This pain was unlike anything I had ever experienced before. It was almost like a hot poker was intermittandly being held to my knee, and a sensation radiated down my leg. It sensationn occurred the evening after the shot was administered, and lasted only that evening. After this experience, I can report that the swelling and pain in my knee has drastically reduced. I feel that the inflammation in my right knee has noticeably decreased, and the swelling has almost completely subsided.
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| 69 | 2021-03-14 | joint pain | Diarrhea, severe joint pain |
| 69 | 2021-03-14 | muscle pain |
Severe nerve/muscle pain starting 3/10/2021. Appearance of shingles blisters on 3/14/2021. Pain wors...
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Severe nerve/muscle pain starting 3/10/2021. Appearance of shingles blisters on 3/14/2021. Pain worsening.
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| 69 | 2021-03-14 | muscle pain |
Immediately, I had a cough, which is odd. But I do have intermittent cough, and this may have trigg...
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Immediately, I had a cough, which is odd. But I do have intermittent cough, and this may have triggered it. It is not covid but cough of long-standing. The next day I had sore arm, muscle pains, cold body temperature (97.1 F), and wheezing. Wheezing was new and it hurt and worried me. Intense fatigue. Wheezing has resolved but the rest still there and it is 11 days since vaccine
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| 69 | 2021-03-14 | muscle pain |
Injection site red and swollen., Nausea and diarrhea. Headache,. Tiredness. Muscle pain. Temperature...
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Injection site red and swollen., Nausea and diarrhea. Headache,. Tiredness. Muscle pain. Temperature (102). Severe chills.
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| 69 | 2021-03-14 | muscle pain | Fever Chills Muscle Aches Fatigue Pain, redness and swelling at injection site |
| 69 | 2021-03-14 | neck pain |
Headache, Neck ache, then Fever 3/13/2021 10:30 evening headache started thru the night, Sunday 03/1...
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Headache, Neck ache, then Fever 3/13/2021 10:30 evening headache started thru the night, Sunday 03/14/2021 fever started thru out the day until Monday morning 03/15/2021 then slight headache again
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| 69 | 2021-03-15 | joint pain |
Being in the Mall, accompanied by her cousin, felt a severe headache and pain in both shoulders foll...
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Being in the Mall, accompanied by her cousin, felt a severe headache and pain in both shoulders followed immediately by fainting, cardio-respiratory arrest that required call 911 for emergency transfer to Hospital. She was intubated in the emergency room treated by the doctors, Cardiologist and Intensive care where she was subjected to hypothermia and other treatments due to the serious neurological damage that she presented. No other organ seemed compromised. Never came out of the coma, passing away on February 26, 2021.
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| 69 | 2021-03-15 | back pain |
Chills at onset only; then fever, occassional headache & backache, and lethargy for 48 hours. Temp ...
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Chills at onset only; then fever, occassional headache & backache, and lethargy for 48 hours. Temp averaged 100, hit 101 once, 102 once. Took acetaminophen 3X during the 48 hour period. After 48 hours 100% normal.
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| 69 | 2021-03-16 | joint pain | Fever 101 degrees, joint aches, lasting 8 hours; rash on upper trunk lasting 3 days |
| 69 | 2021-03-16 | groin pain, back pain |
Severe back ache and groin. Like a kidney infection. Hard to move without experiencing pain. This is...
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Severe back ache and groin. Like a kidney infection. Hard to move without experiencing pain. This is not a small amount of pain either! Also had a headache first!
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| 69 | 2021-03-17 | joint pain, muscle pain |
3/02/21. Very restless sleep followed by 3 days of very achy muscle and joints, strong sensitivity t...
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3/02/21. Very restless sleep followed by 3 days of very achy muscle and joints, strong sensitivity to light, oral sore spots, ( but not open sores ) and a flushed face. There was no fever. I took Tylenol for the aches and stayed restful, napping during the day . By 03/06/21 I felt fine.
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| 69 | 2021-03-17 | joint pain |
Fever Aches confusion weakness joint paint UNABLE to walk. ending in a 6 day hospital stay. Hospita...
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Fever Aches confusion weakness joint paint UNABLE to walk. ending in a 6 day hospital stay. Hospital says it could not be caused by the vaccine 2 covid
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| 69 | 2021-03-17 | joint pain |
Low grade fever ( 100.3), joint pain, severe fatigue, mild nausea Dizziness ( fogginess) "Flu-like" ...
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Low grade fever ( 100.3), joint pain, severe fatigue, mild nausea Dizziness ( fogginess) "Flu-like" symptoms for 48 hours
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| 69 | 2021-03-17 | back pain |
Client reports 3-4 hours after vaccination developed s/sx of lip swelling and hives. Self reported t...
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Client reports 3-4 hours after vaccination developed s/sx of lip swelling and hives. Self reported to a quick care center and was treated with benadryl and was instructed to take daily x4 days, during which time s/sx resolved. Last dose taken on 3/10/2021. Client reports that on 3/13/21 s/sx returned with swelling of lips. Reported to the ER on that day and was again treated with benadryl. Denied any problems with breathing so declined epi. On 3/14 s/sx included itchy scalp and neck and back pain. Reports to have seen PCP on 3/16 and was prescribed singular daily and an antihistamine (not benadryl). Symptoms have since resolved.
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| 69 | 2021-03-19 | muscle pain |
Rash on injection site, swelling on the arm, chills, rash on vaginal and anal area, hives on chest, ...
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Rash on injection site, swelling on the arm, chills, rash on vaginal and anal area, hives on chest, back, and arms, fatigue, and muscle aches
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| 69 | 2021-03-20 | joint pain |
extreme headache, extreme eye ache, aching joints, queasy stomach, low fever, diarrheas. Lasted 2 da...
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extreme headache, extreme eye ache, aching joints, queasy stomach, low fever, diarrheas. Lasted 2 days
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| 69 | 2021-03-21 | limb discomfort |
Patient woke up in the morning after her vaccine, her arm was swollen and red all the way to her elb...
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Patient woke up in the morning after her vaccine, her arm was swollen and red all the way to her elbow, and her arm was painful and heavy and tingling. This continued until the following day with the tingling and swelling. The arm is still red and it is hot to the touch and is extremely itchy. Benadryl helps with the itching.
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| 69 | 2021-03-21 | musculoskeletal stiffness |
Left arm stiffness, numbness, and spasticity on 2/25/21. Overtime the stiffness and numbness involv...
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Left arm stiffness, numbness, and spasticity on 2/25/21. Overtime the stiffness and numbness involved left wrist. By 3/5/21 had numbness in left torso, left thigh, and as of 3/16/21 started getting numbness and stiffness of her right upper extremity.
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| 69 | 2021-03-21 | muscle pain |
Sunday after Saturday night vaccination I woke up with Headache, fever was 101.8, chills ,muscle ach...
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Sunday after Saturday night vaccination I woke up with Headache, fever was 101.8, chills ,muscle aches, very tired- spent day on couch sleeping-next day Monday I still have slight fever 98.9 but am feeling better. NOTE : Sunday at around 5;00 I had to take Excedrin tension headache 1 tab This got rid of my headache !
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| 69 | 2021-03-22 | joint swelling |
Day 1 - 10 hours after- tightness in upper chest/throat and soreness in left arm. Day 2 - Woke up wi...
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Day 1 - 10 hours after- tightness in upper chest/throat and soreness in left arm. Day 2 - Woke up with my finger joints stiff, swollen and throbbing with pain (this subsided on day 4) Day 3 - No symptoms Day 4 - Woke up with rash (burning) on right side of my neck, and headache.
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| 69 | 2021-03-22 | muscle pain |
Symptoms: Severe headache, nausea, muscle aches, very tired, left arm pain, dizziness, weakness - be...
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Symptoms: Severe headache, nausea, muscle aches, very tired, left arm pain, dizziness, weakness - began some time in early morning of March 21 Called Emergency Room. Spoke to ER doctor who recommended: 2 Tylenol, 1/2 Benadryl, plenty of fluids, eating light, light activity level I followed these except used only 1 extra strength Tylenol which I repeated twice during the day. Spent most of day sleeping. Improvement by morning of March 22. March 22 - tiredness continued so limited activity.
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| 69 | 2021-03-23 | back pain | Headache, tremendous back pain from neck to hips, legarthy |
| 69 | 2021-03-23 | bone pain, muscle pain |
Deep bone and muscle aches, severe headache, no appetite, dizzy and disoriented when standing, extre...
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Deep bone and muscle aches, severe headache, no appetite, dizzy and disoriented when standing, extremely tired, all began about 12 hours after injection. Adverse reactions started to subside about 12 hours after onset, and were completely gone after about 36 hours.
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| 69 | 2021-03-23 | neck pain, spinal pain |
Severe pain in spine, neck, chest, and arm. Started about 10 days after the vaccine. Sore throat, la...
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Severe pain in spine, neck, chest, and arm. Started about 10 days after the vaccine. Sore throat, lack of sleep, and lack of hunger or thirst.
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| 69 | 2021-03-24 | joint pain, muscle pain, weight decreased |
Fever, muscle and joint aches, eyeball aches, loss of appetite, extreme fatigue. On the first day af...
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Fever, muscle and joint aches, eyeball aches, loss of appetite, extreme fatigue. On the first day after the second dose (Tuesday, March 16, 2021), I slept 19 hours, sat up for 1 hour, and went back to bed and slept another 16 hours. Upon waking on the second day after the vaccination (Wednesday, March 17, 2021), the fever had broken and the aches were not as severe but still present. No food or drink were consumed as I slept the entire time. On the third day after the vaccination (Thursday, March 18, 2021), aches were gone, but I was so weak with little energy. In addition, I had lost 3.5 pounds since the day of the vaccination. I could not find a thermometer (as well as was too tired to look), so I cannot tell you what my temperature was, but my face/forehead was hot to the touch.
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| 69 | 2021-03-24 | joint pain |
1.DOSE #1: EXPERIENCED TINNITUS IN BOTH EARS FOR FOUR EVENINGS IN SUCCESSION FROM TUESDAY, MARCH 2 ...
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1.DOSE #1: EXPERIENCED TINNITUS IN BOTH EARS FOR FOUR EVENINGS IN SUCCESSION FROM TUESDAY, MARCH 2 THROUGH FRIDAY MARCH 5. THE TINNITUS SUBSIDED GRADUALLY OVER THE NEXT 2 WEEKS (APPROXIMATELY). I AM NOT CURRENTLY, AS OF THIS DATE (MARCH 25) , EXPERIENCING THIS. ASIDE FROM A MINOR SORENESS TO MY ARM LASTING LESS THAN 30 MINUTES, I COULD NOT 'FEEL' THIS INJECTION AND HAD NO OTHER ISSUES FOLLOWING THE VACCINE DOSE #1 UNTIL THE FOLLOWING: 2. DOSE #2: AT ABOUT 9:30 AM ON MONDAY, MARCH 22. THE INJECTION (LEFT ARM, AGAIN) WAS, IN COMPARISON TO THE FIRST 'JAB', CLEARLY UNCOMFORTABLE BUT THIS DID NOT CONCERN ME. HOWEVER, ON MY DRIVE HOME (ABOUT 20 MINUTES) MY ARM GRADUALLY BECAME VERY SORE, AND CONTINUED TO BE PAINFUL AND GET WORSE OVER THE FOLLOWING HOURS. I COULD NOT USE OR LIFT MY LEFT ARM WITH SIGNIFICANT PAIN NOT ALEVIATED BY IBUPROFEN (3 TO 4 AT A TIME). THIS CONTINUED THROUGH WEDNESDAY, MARCH 24 AT WHICH TIME I TOOK ONE (1) TYLENOL AND ONE (1) IBUPROFEN, AND THAT HELPED WITH THE ACHE. AS OF THURSDAY, MARCH 25 (WHEN I AM RECORDING THIS) IT IS LESS PAINFUL, AND I AM ABLE TO LIFT THE LEFT ARM WITH LESS DISCOMFORT. MY SHOULDER SOCKET ALSO SEEMS TO BE LESS PAINFUL. I AM SENDING THIS INFORMATION BECAUSE I READ THAT TINNITUS HAS BEEN EXPERIENCE BY A SMALL GROUP OF VACCINE RECIPIENTS, AND BECAUSE I AM CONCERNED THAT PERSONS THE EXPERIENCE WAS MORE THE WAY THE VACCINE WAS INJECTED (MAYBE NOT IN THE CORRECT LOCATION). I HAVE NOT FELT THE NEED TO SEE A PHYSICIAN OR OTHER HEALTH PROVIDER. I HAVE CHANGED MY insurance AND AM REVIEWING NEW PROVIDERS.
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| 69 | 2021-03-24 | joint pain | Headache,chills, joint pain, fatigue, injection site pain, nausea |
| 69 | 2021-03-25 | musculoskeletal stiffness |
Patient described sore arm that turn into her hand feeling stiff. Specifically her middle finger joi...
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Patient described sore arm that turn into her hand feeling stiff. Specifically her middle finger joints became inflexible. Symptoms resolved over the next week.
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| 69 | 2021-03-25 | muscle pain | Sore arm (muscle not injection) for 2 days and a headache for a week - and still having. |
| 69 | 2021-03-26 | joint pain, muscle pain | Nausea and muscle pain in right shoulder |
| 69 | 2021-03-26 | joint pain, muscle pain |
This is a 70 year old female with paroxysmal atrial fibrillation (anticoagualted on Eliquis), obstru...
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This is a 70 year old female with paroxysmal atrial fibrillation (anticoagualted on Eliquis), obstructive sleep apnea (uses CPAP), mitral valve regurgitation, remote tobacco use, hypertension and dyslipidemia who presents to the ED for worsening dyspnea, cough, subjective fever, chills and body aches that have been ongoing for the past several days. The patient indicates that her dyspnea is exacerbated with exertion but she denies chest pain, pleuritic chest pain, leg swelling or calf pain. She mentions that she has received both of her COVID-19 vaccines (Pfizer); the first immunization was on 02/25 followed by her second immunization which took place eight days ago on 03/18. She is not confident that she has had any contact with a known sick or definitive COVID-positive individual recently. Of note, the last documented incidence of testing for COVID-19 was performed on 10/31/2020 after the patient was seen at a Clinic after a exposure for a COVID-positive individual. Testing at that time had resulted negative. To her knowledge, she states that she had, in fact, tested positive for COVID-19 in late fall of 2020, but she was not hospitalized. Yesterday (3/26/2021), she was evaluated at a Pharmacy where she was testing for COVID-19 which has since resulted positive. The patient denies any other acute symptoms of illness. In the ED, the patient was found to have acute respiratory failure with hypoxemia and pneumonia due to SARS-CoV-2 infection. Review of Systems Constitutional: Positive for chills, fatigue and fever. Negative for activity change. Respiratory: Positive for cough and shortness of breath. Cardiovascular: Negative for chest pain and leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Positive for arthralgias and myalgias. Negative for gait problem. Neurological: Negative for syncope. All other systems reviewed and are negative. Vitals Blood pressure 159/79, pulse 65, temperature 36.4 °C (97.5 °F), temperature source Oral, resp. rate 18, height 1.6 m (5' 3"), weight 107 kg, SpO2 98 %. Physical Exam Vitals reviewed. Constitutional: General: She is awake. She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is morbidly obese. She is ill-appearing. She is not toxic-appearing. Interventions: Nasal cannula in place. HENT: Head: Normocephalic and atraumatic. Nose: Congestion present. Mouth/Throat: Mouth: Mucous membranes are dry. Pharynx: Oropharynx is clear. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Decreased breath sounds present. Comments: Diminished breath sounds in all lung fields. Occasional cough. Abdominal: General: Bowel sounds are normal. There is no distension. Palpations: Abdomen is soft. Tenderness: There is no abdominal tenderness. Musculoskeletal: General: Normal range of motion. Cervical back: Normal range of motion and neck supple. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Behavior: Behavior is cooperative.
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| 69 | 2021-03-26 | limb discomfort |
Couple of days after first Vaccine my left leg just above my ankle on underneath the skin it felt li...
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Couple of days after first Vaccine my left leg just above my ankle on underneath the skin it felt like the blood getting very hot and feverish for a few minutes then go away for awhile then do it again and happening constantly. Then in my 3rd week it jumped to middle of leg and then up to lower knee (all left leg), then go back down to ankle. It just feels like hot blood under the skin. I then called my primary doctor and they had me do in as I was concerned it could be a blood clot, but he checked and assured me it wasn't. Dr. said they have been seeing patients with same issue I am having, having the Pfizer shots but those people have in both legs or both arms and he really couldn't give me a answer but to report to CDC. He said to proceed with second shot which I did and still having same issue. I called my primary doctor back again this week as this continues with "Hot Spots" and I was experiencing numbness in two small toes on left leg and next 2 toes tingling and concerned for these "Hot Spots" (no rashes). He is now setting me up for a sonogram to reassure me it isn't a blood clot. I was never sick with the shot, just minor soreness in arm for following day and tired on first round. Called me a prescription in for Gabapentin 300mg.
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| 69 | 2021-03-27 | joint pain, muscle pain |
mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; jo...
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mild nausea; Syncope (2x) w/mild seizure; Syncope (2x) w/mild seizure; Flu-like symptoms; chills; joint/muscle pain; joint/muscle pain; injection site pain; headache; labored breathing; dry-heaving after second syncope; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient, not pregnant, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: LOT 6205 (as reported)), via an unspecified route of administration in the right arm, on 08Mar2021, at a single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included sertraline; docusate sodium, ferrous fumarate (FERRO-SEQUELS); and multivitamin - all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201) on 15Feb2021 17:00 in the right arm for covid-19 immunization at 69-years-old. The patient did not have covid prior vaccination. The patient did not receive any other vaccines in four weeks. The vaccine was given at the public health clinic. The following day on 09Mar2021 15:30 after a short walk, the patient experienced flu-like symptoms, chills, joint/muscle pain, injection site pain, headache, syncope (2x) with mild seizure, labored breathing, and dry-heaving after second syncope. The patient was then taken by ambulance to the ER (resulted in an emergency room visit) and was given saline fluids via IV. The vitals and EKG were "ok" on 09Mar2021. The patient recovered relatively quickly and was released. The only symptoms remaining on 11Mar2021 were mild headache and mild nausea. The patient had not recovered from headache and nausea at the time of the report; while recovered outcomes on Mar2021 for all the other remaining adverse events. The patient was not covid-tested post-vaccination.
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| 69 | 2021-03-27 | joint pain |
I;30 am--chills, fever, severe headache, body / joint aches.... 5:30 am-added nausea to above conti...
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I;30 am--chills, fever, severe headache, body / joint aches.... 5:30 am-added nausea to above continued all of 3/24--fever broke 3/25 @4:00am , then other gone with tiredness for rest of day 3/26--okay-back to normal, just little tired
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| 69 | 2021-03-27 | neck pain, back pain, joint pain |
I initially had 2 days or so of feeling very ill. Then ok for 5 days. Then second round of reaction...
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I initially had 2 days or so of feeling very ill. Then ok for 5 days. Then second round of reaction started. Intense pain and swelling of right side of neck for 3 days. Also left wrist unable to use. Pale, ill. Vital signs ok. Then on 3/8, pain switched to left side of neck and upper back. 3/10, right neck again with swollen lymph nodes bilateral. 3/11 back of neck and upper back hurts. Intense. Could not sleep. 3/12 pain in upper quads and hips, mid pack. Feeling freezing cold. Temp ok. Called my Dr. Right side of neck continued to hurts even now (3/28/2021) but at least I can function now. I no longer feel sick, brain fog, cold. So greatly improved but not normal. Reaction has lasted a month. Vaccine number one resulted in 2 days feeling ill with upper back pain, chills but only a few days. First night vomited, passed out. First vaccine reaction was frightening but was short lived. I am a retired RN.
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| 69 | 2021-03-28 | joint pain, muscle pain |
At 3:10 am the day after the 2nd Dose . Woke feeling Hot ( Fever ) bad Headache , Tiredness , Muscle...
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At 3:10 am the day after the 2nd Dose . Woke feeling Hot ( Fever ) bad Headache , Tiredness , Muscle pain , Joint pain , Injection site pain , swelling , rash and redness. Dizziness and weakness .
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| 69 | 2021-03-28 | back pain |
Herpes zoster eruption thoracolumbar region and wrapping about the left ribs to abdomen, severe back...
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Herpes zoster eruption thoracolumbar region and wrapping about the left ribs to abdomen, severe back pain, itching rash
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| 69 | 2021-03-29 | joint pain |
slight headache; extremely dizzy; joints ached; nauseated; felt really weak; This is a spontaneous r...
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slight headache; extremely dizzy; joints ached; nauseated; felt really weak; This is a spontaneous report from a contactable nurse (patient). This non-pregnant 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) via an unspecified route of administration in the left arm on 23Feb2021 at 07:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, COVID-19, tape allergy, and osteoarthritis all from unknown dates and unknown if ongoing. The patient reported taking concomitant medications. The patient previously received nubain for an unknown indication and experienced allergy, codeine for an unknown indication and experienced allergy, oseltamivir phosphate (TAMIFLU) for an unknown indication and experienced allergy, and amoxicillin sodium; clavulanate potassium (AUGMENTIN) for an unknown indication and experienced allergy.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Feb2021 after receiving her injection, she went home and in a little while she had a slight headache. She took a muscle relaxer and went to bed around 11:30. When the patient got up to go to the bathroom, she was extremely dizzy, her joints ached, she was nauseated and felt really weak. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of slight headache, extremely dizzy, joints ached, nauseated and felt really weak were recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.
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| 69 | 2021-03-29 | musculoskeletal chest pain | chest pain (intermittent) under rib cage. Evaluated by EMS-Cleared |
| 69 | 2021-03-30 | back pain |
excruciating low lumbar pain from L5 and S; Was unable to walk and sit; This is a spontaneous report...
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excruciating low lumbar pain from L5 and S; Was unable to walk and sit; This is a spontaneous report from a contactable nurse(patient). The 69-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 13Mar2021 16:15 (Lot Number: EN6204) as single dose for precautionary for getting covid 19. Medical history included severe asthma, she had lumbar fusion T9-L5. Her lumbar back area was the worst area on her body even before she got the Covid vaccine. She had been in pain all the time 24 hours a day, 7 days a week. There were no concomitant medications. On 14Mar2021 morning, she was unable to walk and sit, experiencing excruciating low lumbar pain from L5 and S. It continued all day, pain excruciated was screaming and crying until yesterday afternoon went to the hospital. She had not experienced pain ever like this. If she got up to use the bathroom, it was pain, excruciating pain the whole time she's up. The hospital didn't admit her because she did an MRI with contrast and without contrast and it showed no changes from her last MRI in Nov2020. She was still in severe pain. Doctor in the emergency room gave her 2 IV push of hydromorphone hydrochloride (DILAUDID) and did nothing. There was no pain as long as she's not moving but when she got up or move or go to the washroom to urinate has excruciating pain. She was supposed to get on the plane tomorrow not able to get out of bed. Pain was localized in one area like stabbing burning and excruciating pain if moving. It's not like a muscle or joint pain you get from a flu vaccine. She was prescribed Oxycodone 5/325 from the emergency room. She didn't take any oxycodone last night, she was hesitant to take pain meds. She was laying prone in bed except to get up to restroom, her husband gave her one of the oxycodone before he left for work this morning. It was unknown if the oxycodone was working, since she hadn't moved yet, she's laying prone and had not moved to the right or to the left and she just took it about 45 minutes ago. Lab data also included blood work, MRI with and without contrast, Covid test, with unknown results. Seriousness criteria for events was disability. Outcome of events was not recovered. She asked the emergency room doctor could this be related to the Covid vaccine and the doctor would not state whether he thought it was or was not. She's thinking it was related because it is so new and it's the only thing new that's been introduced into her body. Relatedness of drug to reactions by reporter was related.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported excruciating low lumbar pain from L5, which resulted unable to walk and sit, and the administration of the COVID19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 69 | 2021-03-30 | muscular weakness |
Entire left leg muscle weakness started one week after injection about March 20 in the morning. Cou...
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Entire left leg muscle weakness started one week after injection about March 20 in the morning. Could not put full weight on left leg and walk without pain (muscle is only painful when walking or turning leg, not painful to touch) Weakness started subsiding a little on March 29, 2021, but as of this message I still have some weakness. I have been walking and exercising muscles to keep leg active and hopefully strengthen muscles. I contacted my primary doctor for advice on taking 2nd injection.
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| 69 | 2021-03-30 | weight decreased, muscle pain, joint pain |
Vomiting; sore throat; joint and muscle pain; joint and muscle pain; loss of appetite; cough; extrem...
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Vomiting; sore throat; joint and muscle pain; joint and muscle pain; loss of appetite; cough; extreme fatigue; diarrhea; lost 10 pounds in one week; This is a spontaneous report received from a 69-years-old female consumer (patient) reported that. A 69-years-old female patient received bnt162b2 (BNT162B2;solution for injection; Lot no#EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 04:00 PM as single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medications included lisinopril (LISINOPRIL) 20 mg once a day. On 03Mar2021, the patient experienced vomiting, sore throat, joint and muscle pain, loss of appetite, cough, extreme fatigue, diarrhea, lost 10 pounds in one week. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Mar2021 covid test type post vaccination=Nasal Swab. The patient was not received treatment for the adverse event. Outcome of events were not recovered. Patient was not pregnant at the time of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
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| 69 | 2021-03-31 | back pain, muscle pain |
severe pain in her upper middle part to the right portion of her back; pain is in the muscles; she c...
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severe pain in her upper middle part to the right portion of her back; pain is in the muscles; she couldn't take a deep breath; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection) dose 1 via an unspecified route of administration, administered in left arm on 10Mar2021 13:45 (69-year-old at time of vaccination) (Batch/Lot Number: EN6204) at a single dose for covid-19 immunisation. Medical history included ongoing blood cholesterol d and thinks she was diagnosed about 3 years ago. Patient was taking unspecified statins 5 mg, once a day, by mouth. Patient got the first dose of the Pfizer COVID-19 vaccine on 10Mar2021 (Sunday). On 14Mar2021 at 10AM, she experienced a localized severe pain in her upper middle part to the right portion of her back. She said that it is a pain in the muscle where her scapula pulls and maybe the muscle that covers the lung. Because of that pain she couldn't take a deep breath. She has tried different things such as taking Tylenol and placing ice packs to numb the pain. It presented until yesterday (15Mar2021) then it became better, then it came back again last night. She was feeling better today. She can't think of anything physical that might have contributed to her adverse event. She is scheduled for her second shot on 31Mar2021. Additional information included that there was a horrible sharp pain on the right side of her back underneath the scapula, hurt like crazy, couldn't take a deep breath . Patient took Pfizer BioNTech Covid vaccine (Verbatim): so that she will be able to see her grandkids again, and she wants to be safe. Patient reported she did not do anything to injure herself, so she was wondering if this could be caused by the vaccine. the pain was almost gone today; she can take a deep breath and it only hurts a little bit. She could not take a deep breath yesterday (14Mar2021), but she can today (15Mar2021). She described that it was really bad yesterday. She wants to know if other people have reported the pain on the muscle that goes around the back of the lung. She asked if this was related to the shot. The vaccine was given in a high school gym. There was no history of all previous immunization with the Pfizer vaccine considered as suspect neither additional vaccine administered on same date. Patient did not require to visit emergency room and physician office. She added thather husband received the vaccine at the same time and he didn't have any reactions. She also reports she was tested one time for covid and it was negative; clarified this was months ago and she doesn't remember any testing that came out bad. Outcome of the events back pain and muscle pain were unknown while Dyspnea was recovering.
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| 69 | 2021-03-31 | musculoskeletal stiffness |
1) After the first shot, my blood pressure went up, and I felt dizzy and light-headed with a pressur...
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1) After the first shot, my blood pressure went up, and I felt dizzy and light-headed with a pressure behind my left ear at the base of the skull. They kept me for a while until it went down, and I was ok. 2) I didn't notice any effects initially after the second shot, which I was expecting. In fact, I felt so good that I went on a 12-mile bicycle ride. However, I began to experience diarrhea around 6:30 that evening. The next day I had headache, stiff neck, body aches, and a general malaise. The next day I had a rash all over my torso. Those effects ceased, but on Saturday evening I broke out in hives on several areas of my legs, buttocks, and elbow. The hives were gone by the next day. The only thing that remains is a slight stiff neck. I never had fever, chills or any breathing problems. I spoke to my doctor the next day, and she was satisfied that I did not have any lingering symptoms or problems.
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| 69 | 2021-04-01 | muscle pain, joint pain | Chills, nausea, headache, achy joints/muscles for 24 hrs |
| 69 | 2021-04-02 | joint pain |
Pain in left knee. I cannot put my weight on it.; This is a spontaneous report from a contactable co...
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Pain in left knee. I cannot put my weight on it.; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 16Mar2021 15:00 (Lot Number: En620A) as SINGLE DOSE for covid-19 immunisation, at 69 years old at Pharmacy or Drug Store. Medical history included allergies: food from an unknown date. Patient is not pregnant. No COVID prior vaccination. No other vaccines in four weeks. No other medications in two weeks. Patient received the first dose of BNT162B2, (Lot number: En198) on 23Feb2021 15:00 at right arm for Covid-19 immunization, at 69 years old. The patient's concomitant medications were not reported. The patient experienced pain in left knee. She cannot put my weight on it on 16Mar2021 16:00. Treatment was received for the event (reported as ultra sound and X ray). Lab tests included ultra sound and x ray with unknown results on Mar2021. Event required emergency room and physician office visit. Patient was not tested for COVID post vaccination. Outcome of the event was not recovered. Seriousness criteria was reported as disability.
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| 69 | 2021-04-02 | muscle pain | Extreme tiredness, muscle aches, pain at injection site |
| 69 | 2021-04-03 | joint pain, muscle pain |
staggering - balance off; severe exhaustion; fever; headache; extreme joint pain; nausea; feeling un...
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staggering - balance off; severe exhaustion; fever; headache; extreme joint pain; nausea; feeling unwell; earache; arm numb and tingling; arm numb and tingling; chills; muscle pain; fast heart rate; injection site pain; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 12Feb2021 10:30 as SINGLE DOSE for covid-19 immunisation. Medical history included arthritis, fibromyalgia, asthma, and covid-19. The patient previously took cipro, zithromax, z pack and ketoprofen and experienced allergies. The patient experienced staggering - balance off, severe exhaustion, fever, headache, extreme joint pain, nausea, feeling unwell, earache, arm numb and tingling, arm numb and tingling, chills, muscle pain, fast heart rate and injection site pain on 12Feb2021 at 13:30. The patient underwent lab tests and procedures which included heart rate was fast on an unspecified date. Outcome of the event was recovering. Information on the Lot/Batch number has been requested.
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| 69 | 2021-04-03 | joint pain |
I experienced several commonly reported vaccine side effects for a few days after the vaccine (body ...
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I experienced several commonly reported vaccine side effects for a few days after the vaccine (body aches, headache, exhaustion, low grade fever, chills, joint pain/stiffness, mild nausea.) Then about 2 weeks after the second vaccine dose I developed a macular rash on my chest and then a day later on my upper back. The rash lasted a few days. I don't get rashes without cause and never had a rash such as this, so it seemed possible it was related to the vaccine. The rash was itchy but not painful, and it dissipated over a few days time. It was not problematic for me, but since the COVID vaccine is new and information is evolving I thought I should report it.
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| 69 | 2021-04-05 | joint pain |
On 3/24, I woke up nauseous, extremely fatigued, with sore joints, headache, and abdominal pain. A ...
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On 3/24, I woke up nauseous, extremely fatigued, with sore joints, headache, and abdominal pain. A few days later I noticed I had extreme shortness of breath. I went to see my PCP on or about 3/31. He listened to my heart and discovered a rapid heartbeat. He then took an EKG. He wanted to put me on lifetime meds immediately. I was in shock because I truly believe this is a reaction to the COVID vaccine. I have never had arrhythmia. In fact, I had a wellness visit with the Dr. about 3 months previously and all was good. I have been seeing him for four years since I moved. He does not think my new diagnosis is related to a vaccine reaction, but I find it highly suspect that 4 other women in my large circle of friends also have AFIB after 2nd shot. I spent Easter in the ER and they pumped Metoprolol in my bloodstream. I did not stay in the hospital that night. I went to see the Dr. on Monday morning on 4/4. He prescribed Metroprolol 25 mg and Xarelto 20 mg IMMEDIATELY. I picked up the meds and started this regimen. In speaking with other women, I believe this terrible diagnosis is a direct result as a reaction from the vaccine.
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| 69 | 2021-04-06 | armpit pain |
If she laid her arm on it, it was painful on the left side where she got the injection between her l...
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If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla; couldn't go back to sleep; very tired; weak; She had the lump and that was in the lymph node; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; irregular heart beats; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; painful if she put her arm down/painful on the left side/extended underneath the axilla/looked like it was connected to the breast; baseball sized lump. It was hard/where she got the injection; It looked like it was connected to the breast because it was so huge.; Fever blister; heart beating so out of rhythm; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in arm left on 18Mar2021 at 12:20 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing coeliac disease; hypothyroidism, is diabetic and has irregular heartbeat from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine taken for hypothyroidism; hydrochlorothiazide, olmesartan medoxomil (OLMESARTAN/HCTZ MYLAN) taken for blood pressure measurement; metformin, glipizide and pioglitazone hcl taken for diabetes mellitus; acetylsalicylic acid (ASPIRIN 81) taken for thrombosis; metoprolol taken for heart rate irregular, cyanocobalamin (VIT B12) taken for an unspecified indication, all from an unspecified start date and ongoing; famotidine, rosuvastatin, vitamin d2, vitamin d3 and potassium, all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (lot number: EN6198, NDC: 59267-1000-1, expiry: unknown) on 27Feb2021 at 1:40PM for COVID-19 immunisation. The patient got her last shot on 18Mar2021. The first day was fine. She woke up the next morning at three or four with her heart beating so out of rhythm it was crazy. It took almost the whole day. She called her cardiologist and couldn't get into them and she didn't want to go to the ER. She didn't have a way to prove any of that. She also got a baseball sized lump. It was hard. If she laid her arm on it, it was painful on the left side where she got the injection between her left breast and axilla. It extended underneath the axilla. She wasn't able to get in with the cardiologist because she waited to late in the day. She couldn't get off the couch that day because her heart was so out of rhythm. She was very tired and wanted to just lay down. She hates going to the hospital. She doesn't want to go to the hospital. She has a history of irregular heartbeats. She should have gone in and had an EKG. She has pictures of the lump if those are needed. HCP information: Her doctor had said if she had anything like any abnormal heart beats to come in and get an EKG. She also had a fever blister on 22Mar2021 that she hasn't had in years and was asking if this influences her immune system. She had the lump and that was in the lymph node and now a fever blister on the top lip. Heart beating so out of rhythm: it lasted all that day. She took a nap after she talked to the doctor's office and slept for several hours. When she woke up it was kind of back in rhythm, but it was going in and out. It wasn't as frequent as it was prior to nap. Prior to the nap it was almost continuous. It slowed down a lot on the 19Mar2021 and was gone by 20Mar2021. Outcome of event: She has PAC's and PVC's anyway. That is why she follows up with the cardiologist. They haven't been so out of rhythm as they were after the vaccine. She couldn't go back to sleep. She still has them occasionally and that is kind of normal for her. She was weak and tired. Baseball sized lump: it has gone down. She took pictures to show her friends who were all getting the shots. It is gone now. It might have started on 20Mar2021. She woke up with the lump on Saturday. She has recovered completely. Her daughter said she needed to get it checked out. Reporter had heard of a lump on the breast was a side effect. It looked like it was connected to the breast because it was so huge. Seriousness criteria: It was irritating because it was so big. It was painful if she put her arm down. It was like her breast were engorged. Causality: Heart beating so out of rhythm: she hasn't had it that bad, so she thinks it was. She had it a long time ago, maybe once before, but it never lasted that long or took her down like that. She is not the only one that has had the complaint of irregular heartbeats. She put on social media what she experienced and how weak she got. Several friends said that happened to them as well. She doesn't know their history. Reporter declined to do a report on her friends. That was another reason she didn't go to the hospital. She thought it was a normal side effect. She thinks she found on her paperwork about the lump in the lymph nodes. The patient underwent lab tests and procedures which included electrocardiogram: unknown results and heart rate: irregular on an unspecified date. The outcome of the event fever blister was not recovered, while of the rest was unknown. Reporter seriousness for heart beating so out of rhythm was reported as disabling.; Sender's Comments: Based on the information currently available and the plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events 'heart beating so out of rhythm ', 'baseball sized lump (where she got the injection/It looked like it was connected to the breast because it was so huge)' cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-04-07 | joint pain |
Fever of 101 for 48 hours; stabbing pain in joints; sore arm; This is a spontaneous report from a co...
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Fever of 101 for 48 hours; stabbing pain in joints; sore arm; This is a spontaneous report from a contactable consumer. This 69-year-old (at the time of vaccination) female consumer reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EN6201) via an unspecified route of administration on 15Feb2021 at 01:30 pm at single dose on right arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient's medical history included high blood pressure (dates unspecified). Past drug included known allergies; lisinopril. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL8982) on 25Jan2021 at 02:00 pm at single dose on right arm for covid-19 immunisation. Vaccine facility type was reported as other. Concomitant medications (in two weeks) included losartan potassium (LOSARTIN), meloxicam, ascorbic acid, copper gluconate, fish oil, tocopherol, xantofyl, zeaxanthin, zinc oxide (OCUVITE ADULT 50+), fluticasone. No other vaccine was administered in four weeks. Patient experienced fever of 101 for 48 hours, stabbing pain in joints, sore arm on 16Feb2021 at 03:00 am. No treatment was given for the adverse events. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The outcome of events was recovering.
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| 69 | 2021-04-09 | musculoskeletal stiffness |
Weight: Gained 25lbs; Arm is slightly tender; arm might get a little stiff; excruciating leg crampin...
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Weight: Gained 25lbs; Arm is slightly tender; arm might get a little stiff; excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh/the same pain occurred on the opposite leg around noon and lasted for 15 minutes; excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh/the same pain occurred on the opposite leg around noon and lasted for 15 minutes; the inside of her thighs were a little red on the side, both legs from her thighs to her knees; the shot is already fogging her mind; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of NT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 08:30 (Lot Number: ER8727; Expiration Date: 31Jul2021, at age of 69 years old) at a single dose for covid-19 immunization. Medical history included allergies: Penicillin, Ampicillin, hair color product. The patient's concomitant medications were not reported. She was allergic to Penicillin, and Ampicillin. As a child, always reacted strongly to any vaccination she was given with a fever and flu like symptoms for a couple of days. With Ampicillin, she thought she was having a heart attack. Was told to stop Ampicillin immediately because she could get a heart attack. This was when she was 25 years old and she never went to the ER. She was allergic to a hair color product in the 1990s and it made her scalp itch really badly. Was given a cortisone shot, which she reacted immediately breaking out head to toe in hives. Has no NDC/LOT/EXP for the vaccinations she reacted strongly to as a child. Stated this was in the 1950s or early 1960s. Clarified she did not have a heart attack with Ampicillin, but it felt like she was having one. Has had cardiograms per her request and her heart and heart walls are perfect. The patient received the first dose of the Covid vaccine at 8:30 a.m. this morning on 26Mar2021. Caller reports around 11 a.m., she experienced excruciating leg cramping going from her buttock down behind her knee and rolling to the inside of her thigh, states that the pain lasted 15 minutes. The patient reports the same pain occurred on the opposite leg around noon and lasted for 15 minutes, states that "the pain was so excruciating that she could barely stand up and it was so agonizing it was unbelievable." The patient noticed that the inside of her thighs were a little red on the side, both legs from her thighs to her knees. The patient states that she has not been in the sun, and didn't think it was anything alarming, but this is abnormal for her, states that she received the vaccine in the right arm and her upper torso is fine and her head is clear, asked if anyone else had reported this reaction. She was planned to received the second dose on 16thApr in the early afternoon. The patient stated the COVID shot was already fogging her mind. The patient felt pretty good after first shot. Felt nothing. Fifteen minutes before leaving the diner she got a leg cramp. Was sitting in a booth and didn't think much of it. Attributed it to the way she was sitting. Around 11AM when she got back to her garage, she was in agony. It hurt from the top of her rear all the way down the side to the back of her knee and rolled to the inside of her thigh. She was in such agony and didn't know if she could get out of her chair and walk. By the time she reached her apartment it has subsided. An hour later, same thing happened in the left leg. She was laying in bed and texting because she didn't' know if she would get any other reaction. This leg cramp was even worse. She was in tears. Got off bed to try and walk it off. Initial leg cramp happened in right leg. Was excruciating. Both times it lasted for 15 minutes. Both cramps were from her buttocks, all down to her knees, and rolled over into her thigh. Didn't know if that was a reaction. It is not typical of anything written on Pfizer's information or that she had heard. She was concerned. Heard about blood clots, but not with this particular product. Stated second leg cramp subsided. If it hadn't, she wouldn't have gone to the ER. Leg cramps was so excruciating. Originally thought it was coincidental and stated she will be 70 on (Date withheld). To say she has never had leg cramps before would be a lie. The way the leg cramps were timed was kind of weird. It was absolutely the same kind of cramp and location just on the a different leg. Weight: Gained 25lbs. Doesn't have COVID or any symptoms. Tested three to four months ago and was negative. Received first dose COVID-19 Vaccine today, 26Mar2021, at 08:30AM. First leg cramp began 11:00AM in right leg. Second leg cramp began Noon in left leg. Each time lasted 15 minutes. Not having leg cramps right now. Could barely talk when having leg cramps. Was worried about getting clots in legs. Otherwise she would think it was because she was getting older. She doesn't get leg cramps very often. Doesn't know when the last time she had leg cramps prior to today. Nurse technician at vaccine faculty stated caller's allergy history wouldn't be a problem and she only had to sit for 15 minutes. Received the COVID-19 Vaccine and hardly felt it. Waited for 15 minutes. She was fine until 11AM. She was fine now, but her arm might get a little stiff tomorrow. Arm was slightly tender. Surprised she felt something in her legs. Doesn't know whether to associate it with COVID-19 Vaccine or not. Has nothing to complain about in the upper torso or from the waist up. Wants to know if this is a reaction or coincidence. Stated she expected to have a stiff arm. The outcome of the event "Cramps in legs" and "pain" was recovered on 26Mar2021. The outcome of other events was unknown.
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| 69 | 2021-04-11 | muscular weakness |
Initial nausea and vomiting two weeks after administration, followed by progressive dementia-like sy...
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Initial nausea and vomiting two weeks after administration, followed by progressive dementia-like symptoms, including fatigue, muscular weakness and tremor, confusion, memory problems, lack of concentration. Abandonment of previously routine household and personal tasks. Inattentiveness to personal hygiene. Inability to perform previously routine tasks. Notable lack of concern about lost physical and mental capabilities.
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| 69 | 2021-04-13 | muscular weakness |
Weakness in left leg, blod clots in lungs, severe headaches continuing I went to emergency on Febru...
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Weakness in left leg, blod clots in lungs, severe headaches continuing I went to emergency on February 23, 2021 where I treated for weakness in left leg and was admitted to hospital where I received treatments for a double pulmonary embolism on March 1.
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| 69 | 2021-04-17 | muscle pain |
heart palpitations; Slight headache; Muscle Aches; Left arm hurt; chills; Very high blood pressure; ...
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heart palpitations; Slight headache; Muscle Aches; Left arm hurt; chills; Very high blood pressure; This is a spontaneous report from a . A contactable consumer (reported for herself). The 69-year-old female patient received first dose BNT162B2 (Pfizer Covid-19 Vaccine Lot Number: EP7534 and Expiry date: Unknown) via an unspecified route of administration on left arm at a SINGLE DOSE on 18Mar2021, for COVID-19 immunization. Medical history and concomitant medication were not reported. On 18Mar2021 (the night she received the Pfizer Covid Vaccine, dose one) she woke with her heart pounding (heart palpitations), slight headache, muscle aches, and left arm hurt. When she went to the doctor, on an unspecified date in Mar2021, they took her blood pressure, and it was very high. It was stated that she went to primary care physician and then she was sent to a Cardiologist. On 26Mar2021, she underwent electrocardiogram and echocardiogram, results were normal for both the investigations. On the same day 26Mar2021, she also had Holter monitor test done (electrocardiogram ambulatory) however the results were pending. On 20Mar2021, the patient recovered from the events of slight headache, muscle aches, left arm hurt and high blood pressure, the outcome of the event of pounding heart was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 69 | 2021-04-23 | joint pain |
Have had severe diarrhea for almost 72 hours that is not going away.; Developed fever of 100.2; head...
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Have had severe diarrhea for almost 72 hours that is not going away.; Developed fever of 100.2; headache; chills; aching joints for first 2 days; This is a spontaneous report from a contactable consumer(patient). A 69-years-old female non pregnant patient received second dose of BNT162B2 (BNT162B2, PFIZ-ER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200) via an unspecified route of administration, in arm right on 18Feb2021 at 12:00 as single dose for covid-19 immunisa-tion. The patient medical history was not reported and concomitant medications were none. His-torical vaccine included BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200) via via an unspecified route of administration, in arm right on 28Jan2021 at 12:15 as single dose for covid-19 immunisation. On 18Feb2021 at 15:00, the patient experienced severe diarrhea for almost 72 hours which did not fo away, developed fever of 100.2, headache, chills and aching joints for first 2 days. Patient did not receive other vaccine in four weeks and other medications in two weeks. Patient treatment medications included tylenol for first 2 day and immodium and pepto bismol for three days. Patient did not had COVID-19 prior or since vaccination. The outcome of the events was not recovered.
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| 69 | 2021-04-24 | weight decreased |
she has been sick as a dog; stool green; bleeding from the bowels; internal and external hemorrhoids...
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she has been sick as a dog; stool green; bleeding from the bowels; internal and external hemorrhoids; nausea and vomitting; nausea and vomitting; no appetite and weight loss; no appetite and weight loss; loose bowels; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (BNT162B2) at the age of 69 years, via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ER8727) as a single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient received the first dose of BNT162B2 (lot: EN6205) on 05Mar2021 at the age of 69, for Covid-19 immunisation and experienced not feeling good. The patient experienced loose bowels on 26Mar2021; bleeding from the bowels, internal and external hemorrhoids, nausea and vomiting, no appetite and weight loss on 07Apr2021; and she has been sick as a dog on an unspecified date. The patient further reported that she has been sick as a dog, clarifies this started after her second dose of the Pfizer Covid vaccine. Stated she was given some medication to help stop her loose bowels, called dipheni-atrop, 2.5mg, states to take it for three days as needed for loose stool four times a day, started the medication on 30Mar2021 but stopped taking it because it was not doing any good. The patient has lost 7lb. The patient was taking iron and was turning stool green, it bothered her to see the stool green, so she stopped taking it too. Last night the patient drank two sips of soft drink and ate a cucumber and a cup of soup and just sat down and started vomiting. States after the second dose this started, the nausea and vomiting, no appetite, lost weight, loose stools, hemmorhoids internal and external, bleeding in the stool. States doctor wanted a stool sample but she has not been able to get one. The outcome of the event bleeding from the bowels was recovering, she has been sick as a dog was unknown and not recovered from all the other events.
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| 69 | 2021-04-25 | muscular weakness |
Acute onset of left lower extremity weakness and paraplegia that started 2/23/2021, followed by Pulm...
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Acute onset of left lower extremity weakness and paraplegia that started 2/23/2021, followed by Pulmonary embolism 3/5/2021, on Pradaxa
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| 69 | 2021-04-27 | joint swelling, rheumatoid arthritis |
prior to onset of event she did not have any rheumatoid arthritis problems in her knees; additional ...
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prior to onset of event she did not have any rheumatoid arthritis problems in her knees; additional swelling in her knees; feels like she is gaining weight; can't get her brain to work; more swelling on her waist and back/Additional swelling around her waist/ looks like she has lumps; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration (at the age of 69-years-old), administered in Arm Left on 08Apr2021 14:30 (Lot Number: EW0151; Expiration Date: 11Apr2021) as single dose for COVID-19 immunization. Medical history included rheumatoid arthritis from 2020 and ongoing (fought with it all last year in 2020; but was not diagnosed with rheumatoid arthritis until Feb2021), ongoing chronic obstructive pulmonary disease (probably really got with it about 2012), Breast cancer survivor from 2006 to 2006, and bone density. Concomitant medications included cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication from 16Mar2021 to an unspecified stop date; cortisone (CORTISONE) taken for an unspecified indication from 01Feb2021 to 01Feb2021; methotrexate (METHOTREXATE) taken for rheumatoid arthritis from 06Feb2021 to an unspecified stop date; denosumab (PROLIA) taken for bone density abnormal from 16Mar2021 to an unspecified stop date. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 69-years-old), administered in Arm Left on 12Mar2021 about 16:00-16:30 (Lot Number: EN6204) as single dose for COVID-19 immunization and experienced additional swelling in her knees and rheumatoid arthritis. The patient had preexisting condition of Rheumatoid arthritis prior to any Pfizer-BioNTech COVID-19 Vaccine. Prior to onset of this event, with her rheumatoid arthritis, she did not have any rheumatoid arthritis problems in her knees. With the rheumatoid arthritis it has always been in her hands and arms. She was taking Methotrexate for Rheumatoid arthritis. Rheumatologist told her that additional swelling in her knees event was rheumatoid arthritis. After second dose of Pfizer-BioNTech COVID-19 Vaccine she reported additional swelling around her waist. She had second dose of Pfizer-BioNTech COVID-19 Vaccine shot on 08Apr2021. On 11Apr2021 she noticed additional swelling around her waist. She asked if these swelling events are a side effect of the Pfizer-BioNTech COVID-19 Vaccine, or in combination with her rheumatoid arthritis. Onset time was about 05:30-06:00 after she took a shower, pretty much the same thing as with the first dose: additional swelling in her knees. She noticed swelling around the waist, going towards the back which didn't look right on 11Apr2021. There's no pain at all, it just looks like she has lumps. She has had no other effects from the Pfizer-BioNTech COVID-19 Vaccine other than feels like she is gaining weight. Patient reported no other relevant concomitant products or other medical conditions. She mentioned regarding Methotrexate that they tell her this is a high-quality drug that knocks the immune system down. While providing dates of concomitant product doses caller mentioned she can't get her brain to work on an unspecified date. The outcome of the events "prior to onset of event she did not have any rheumatoid arthritis problems in her knees" and "more swelling on her waist and back/Additional swelling around her waist/ looks like she has lumps" was not recovered while for the rest of the events was unknown. The event "prior to onset of event she did not have any rheumatoid arthritis problems in her knees" was considered as serious (medically significant). No follow-up attempts are completed; information about batch/lot cannot be obtained.
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| 69 | 2021-04-27 | rheumatoid arthritis |
it was the arthritis/ it was the rheumatoid arthritis/additional swelling in her knees; This is a sp...
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it was the arthritis/ it was the rheumatoid arthritis/additional swelling in her knees; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 12Mar2021 (Lot Number: EN6204, expiry date not reported) as single dose for COVID-19 immunization. Medical history included rheumatoid arthritis from Jan2021 and ongoing (Verbatim: Rheumatoid arthritis/She says she just got diagnosed with arthritis in Jan2021), ongoing chronic obstructive pulmonary disease, breast cancer female from 2006 to 2006 (Verbatim: Breast cancer survivor), and bone density abnormal from an unknown date and unknown if ongoing. Concomitant medications included methotrexate taken for rheumatoid arthritis from 06Feb2021 to an unspecified stop date; cortisone taken for an unspecified indication from 01Feb2021 to 01Feb2021; denosumab (PROLIA) taken for bone density abnormal from 16Mar2021 to an unspecified stop date; and cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for an unspecified indication from 16Mar2021 to an unspecified stop date. The patient experienced it was the arthritis/ it was the rheumatoid arthritis/swelling in her knees on 24Mar2021. The patient had a rheumatoid arthritis and after she took the first dose of the Pfizer-BioNTech COVID-19 Vaccine shot, about 12 days later she noticed additional swelling in her knees. She had preexisting condition of Rheumatoid arthritis prior to any Pfizer-BioNTech COVID-19 Vaccine. Prior to onset of this event, with her rheumatoid arthritis, she did not have any rheumatoid arthritis problems in her knees. With the rheumatoid arthritis, it has always been in her hands and arms. She was taking Methotrexate for Rheumatoid arthritis. Rheumatologist told her that additional swelling in her knees event was rheumatoid arthritis. She went to the Rheumatologist for the swelling in her knees and they told her it was the arthritis/rheumatoid arthritis. She had second dose of Pfizer-BioNTech COVID-19 Vaccine shot on 08Apr2021. On 11Apr2021 she noticed additional swelling around her waist. She asked if these swelling events are a side effect of the Pfizer-BioNTech COVID-19 Vaccine, or in combination with her rheumatoid arthritis. Clinical outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.
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| 69 | 2021-04-28 | rheumatoid arthritis |
RA flare; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare pro...
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RA flare; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional and consumer reported that a 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included rheumatoid arthritis (RA). The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient had rheumatoid arthritis (RA) flare. The outcome of the event was unknown. Follow-up attempts are needed; information on the lot/batch number has been requested.; Sender's Comments: The event rheumatoid arthritis (RA) flare was considered as due to underlying condition and unlikely related to the use of BNT162B2. Patient had rheumatoid arthritis as medical history. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 69 | 2021-04-30 | joint pain |
Extreme pain, excruciating at times, in entire upper left arm and shoulder; Extreme pain, excruciati...
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Extreme pain, excruciating at times, in entire upper left arm and shoulder; Extreme pain, excruciating at times, in entire upper left arm and shoulder; This is a spontaneous report from a contactable consumer (patient) reported that a 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration, administered in arm left on 05Jan2021 (at the age of 69-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the home. The patient medical history included high blood pressure, depression, anxiety, neurodermatitis, GERD and sleep apnea. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Concomitant medications included labetalol; bupropion; amlodipine; and mirtazapine all were taken for an unspecified indication, start and stop date were not reported. On 06Jan2021, the patient experienced extreme pain, excruciating at times, in entire upper left arm and shoulder. The reported events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Therapeutic measures were taken as a result of extreme pain, excruciating at times, in entire upper left arm and shoulder as the patient was told to use heating pad, get P.T. The outcome of the events was recovering. It was also reported that the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration, administered in arm right on 26Jan2021 as a single dose for covid-19 immunisation.
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| 69 | 2021-04-30 | bone pain, arthritis |
Tenderness on the injection site; some aches and pains on her body; Can't get out of bed/she couldn'...
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Tenderness on the injection site; some aches and pains on her body; Can't get out of bed/she couldn't' stand up; Her arm was so sore/arm hurt a bit; Bone in body hurt and everyplace she has arthritis was worse; Bone in body hurt and everyplace she has arthritis was worse; Carpal tunnel reacted adversely; A prickly heat rash around her neck, down her chest between her breasts, it is ongoing and persisting; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via unspecified route of administration at arm left on 02Feb2021 08:00 AM at single dose for COVID-19 immunization. The patient's medical history included arthritis and she has had surgeries. Concomitant medication was not reported. The patient received her 1st dose of the Pfizer Covid vaccine on 02Feb2021 and said she was fine up until the night of the same day wherein she woke up from her sound sleep feeling absolutely in pain. Mentioned that the parts of her body where she had arthritis and her carpal tunnel acted up which she has never experienced before and said that she normally did not have problems like this. She also cannot get out of bed and said that her husband had to her help her out and she also had a rash. Currently, she was still experiencing tenderness on the injection site and some aches and pains on her body but not as bad as it previously was. The patient had bone in body hurt and everyplace she has arthritis was worse. The patient had the injection on 02Feb2021 at 8AM, and did ok with it, her arm hurt a bit, not bad, and that night she went to bed, and it was every bone in her body hurt and everyplace she has arthritis was worse, and her carpal tunnel reacted adversely, her arm was so sore, she can't believe it, now she has developed a rash. Her arm hurt that night, is a little tender now, it was not real red, just tender. Her husband had to help her out of bed, she could not stand up, she was not a baby, she has had surgeries, she responds well to that kind of thing, so this was unusual. Yesterday she was in bed all day, she did not get out of bed until 5PM. This all came on all of a sudden, she woke out of a sound sleep, she was totally terribly miserable. States her rash through lasted through yesterday, now she has developed a rash, a prickly heat rash around her neck, down her chest between her breasts, it is ongoing and persisting, but she is sure it will fade, she has had reactions to things before. No further details provided. She has not had any other tests or anything lately. No injections, none of that. Would like to know if she has to get her 2nd dose or not. The outcome of the events her arm was so sore/arm hurt a bit, bone in body hurt and everyplace she has arthritis was worse, Carpal tunnel reacted adversely was recovering/resolving. The outcome of the events rash, pain and cannot get out of bed/she could not stand up was unknown. The outcome of the events tenderness on the injection site was not recovered/not resolved.
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| 69 | 2021-04-30 | muscle pain |
body ache; fever 100.6; Chills; Muscle ache; This is a spontaneous report from a contactable consume...
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body ache; fever 100.6; Chills; Muscle ache; This is a spontaneous report from a contactable consumer. A 69-year-old Female consumer reported in response to Non-HCP letter sent in cross-referenced case which included that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, in arm left on 09Feb2021 12:45 (at the age of 69-year-old) as single dose for COVID-19 immunization. The patient medical history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, in arm left on 19Jan2021 12:30 as single dose for COVID-19 immunization and experienced headache, chills, fever and muscle ache. Patient concomitant medications were not reported. No other product(s) were taken together with the COVID-19 vaccine. illness at time of vaccination was None. On 09Feb2021 at 20:00, patient experienced body ache, fever 100.6, chills, muscle ache lasted about 24 hrs. The patient underwent lab tests and procedures which included body temperature: 100.6 on 09Feb2021. Adverse events did not require visit to Emergency room nor Physician Office. Seriousness of the event was reported as non-serious. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.
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| 69 | 2021-04-30 | weight decreased |
This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 69-year-old fem...
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This is a spontaneous report from a contactable pharmacist (patient). A non-pregnant 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 24Mar2021 at 15:30 (at the age of 69 years old) (Lot Number: ER8732, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, asthma, hypertension, penicillin allergy, and sulfonamide allergy. Concomitant medications included etanercept (ENBREL) from an unspecified start date to 21Mar2021; prednisone; and unspecified blood pressure medication. The patient also received first dose of BNT162B2 for COVID-19 immunisation in left arm on 03Mar2021 at 15:00 (at the age of 69 years old) (lot number: EN6199, unknown expiration). On 25Mar2021, the patient experienced sore arm. On 26Mar2021 at 12:00 PM, the patient had cough, diarrhea, dizziness, fatigue, and loss of appetite. From 27 to 30Mar2021, all symptoms intensified daily and had intermittent chills on 29Mar2021. On 31Mar2021, all symptoms intensified, started using Albuterol inhaler. On 01Apr2021, all symptoms intensified, the patient experienced room spinning dizziness resulted in fall and had temperature 99.9F. On 02Apr2021, the patient visited (hospital name withheld) emergency room, COVID tests negative (Nasal Swab), diagnosis: diverticulitis and pneumonia. Three intravenous antibiotics started metronidazole, clindamycin, and Rocephin. On 03Apr2021, the patient was admitted to hospital with continued antibiotics. On 04Apr2021, electrolyte infusion series started. On 05Apr2021, cough lessening, continued antibiotics and electrolyte infusions. On 06Apr2021, the patient had COVID test negative (Nasal Swab). On 07Apr2021, the patient was transferred to rehab facility with continued antibiotics and electrolyte drinks. From 08 to 14Apr2021, antibiotic courses allowed to expire, symptoms improving, appetite returning slowly (lost 15 lbs; started in Apr2021), negative COVID test (Nasal Swab). On 15Apr2021, the patient was released to home. On 16Apr2021, the patient's diarrhea stopped, slight dizziness remains, appetite improving. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination. The patient received metronidazole, clindamycin, rocephin, electrolytes as treatment for the events. The events resulted in emergency room/department or urgent care visit. The patient was recovering from events diverticulitis, pneumonia, sore arm, cough, dizziness/room spinning dizziness, fatigue, loss of appetite, intermittent chills, fall, and temperature 99.9F. Outcome of lost 15 lbs was unknown. The patient recovered from diarrhea on 16Apr2021. The events diverticulitis, pneumonia, sore arm, cough, diarrhea, dizziness/room spinning dizziness, fatigue, loss of appetite, intermittent chills, fall, and temperature 99.9F assessed as serious (hospitalization) for 6 days. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 69 | 2021-05-04 | neck pain, joint pain |
Injection site pain and swelling; Injection site pain and swelling; mild headache and sensitivity to...
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Injection site pain and swelling; Injection site pain and swelling; mild headache and sensitivity to light; mild headache and sensitivity to light; muscle pain around shoulders and neck; muscle pain around shoulders and neck; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6201)), via an unspecified route of administration, administered in arm left on 08Feb2021 14:00 (at the age of 69-years-old) at single dose for COVID-19 immunization, the patient was not pregnant at the time of vaccination. The patient medical history included bronchitis chronic, uterine cancer from an unknown date and unknown if ongoing. The patient previously received codeine and experienced drug hypersensitivity within 2 weeks. The patient concomitant medications were not reported. The patient did not receive any other vaccines and was not tested for covid test prior to the COVID vaccine. On 08Feb2021 18:30 (04 hours and 30 minutes after the vaccination), the patient experienced injection site pain and injection site swelling, mild headache and sensitivity to light (headache), (photophobia), muscle pain around shoulders and neck (arthralgia), (neck pain). The patient did not received treatment for the adverse event. Seriousness of the event was reported as non-serious. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected
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| 69 | 2021-05-07 | muscular weakness |
everything began to swim in front of her/Felt her knees giving out. Woke up face down on floor.; BP ...
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everything began to swim in front of her/Felt her knees giving out. Woke up face down on floor.; BP it was quite high; Blood began to drip from head wound.; blood began to drip from head wound; limbs felt rubbery and out of sorts; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 08:30 (Lot Number: ER8732) (at the age of 69-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. The patient not tested positive to COVID-19 pre or post vaccination. The patient medical history was not reported. Concomitant medications included amlodipine; fluoxetine; metoprolol and omeprazole, all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient reported that on 24Mar2021 at 9:15 everything began to swim in front of her, the sink, counter, coffee pot, etc. Grabbed edge of sink to steady herself. Felt her knees giving out. Woke up face down on floor. Her limbs felt rubbery and out of sorts. Blood began to drip from head wound. Grabbed counter edge and pulled herself upright. Grabbed paper towel for compress. Wobbled over to sofa. She laid down. Her husband came home measured her blood pressure (BP) it was quite high and would not go down. She went to ER immediately. At ER, they took blood, observed, did Echo on heart and sent her home. No therapeutic measures were taken as a result of the events. The patient outcome of the events was recovered.
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| 69 | 2021-05-09 | joint pain |
Later same day: full body itch and tingle. Since vaccine: increased food allergies and multiple j...
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Later same day: full body itch and tingle. Since vaccine: increased food allergies and multiple joint ache/stiffness
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| 69 | 2021-05-09 | limb discomfort, muscular weakness | NUMBNESS. FATIGUE Slight fever yesterday from 2ND DOSE vaccine 02/16/2021 |
| 69 | 2021-05-14 | limb discomfort |
Knocked out for 2 days, couldn't eat or drink, felt unconscious; Swollen Arm; Fever; Chills; Aches; ...
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Knocked out for 2 days, couldn't eat or drink, felt unconscious; Swollen Arm; Fever; Chills; Aches; Headache; Fatigue; Pain in legs so bad cannot handle it; Edema from face down to ankles; Lump on arm, left groin, underarm, back of neck; Weakness; Can't lift arm; Knocked out for 2 days, couldn't eat or drink, felt unconscious; Sense of smell funny at times; ; lymph nodes that were as big as golf balls and are still swollen and still sore; ; lymph nodes that were as big as golf balls and are still swollen and still sore; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 02Apr2021 14:00 (lot number: EP7534; Expiration Date: 31Jul2021) at the age of 69 years old, as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included ongoing allergy to mold, mildew, dust, pollen, some trees, dander, ongoing lactose intolerant, ongoing bronchitis chronic (stated that she gets this from any sinus or allergy), ongoing bowel intussusception (was causing bowel blockages, every 2 days or so. Diagnosed about 2 years ago; monitored by Gastroenterologist), ongoing Nonpolyposis colon cancer (diagnosed about 35 years ago. Says polyps would grow to be cancerous if not monitored regularly). Concomitant medications included linaclotide (LINZESS) taken for intestinal obstruction, start and stop date were not reported; epinephrine (EPIPEN) taken for anaphylactic reaction, start and stop date were not reported. The patient previously received bnt162b2, first dose, on 12Mar2021 at the age of 69 years old for COVID-19 immunization and experienced sore arm (Lot Number: EN6202; Expiry Date: 30Jun2021). No other vaccines received 4 weeks prior to COVID vaccine. The patient has gone to her doctor already. She was kept 45 minutes after her second dose of the COVID vaccine. On 02Apr2021, her arm started to swell up, and she left. A couple of hours later (02Apr2021), she was in bed with a fever, chills, aches, a headache, and stated she was knocked out for 2 days. In those 2 days she couldn't eat or drink and felt like she was unconscious. Her husband had to wake her up and make her drink. Now, a month later, she still has fatigue. She still has pains, pains in her legs are so bad she cannot handle it. She keeps getting chills, headaches, fatigue, states she takes an aspirin for it every day. Says she never lost her sense of smell, but it is funny at times. States she could sleep all day she has so much fatigue. She asked what is going on with her. She asked why are her symptoms prolonged? Why are her legs hurting so bad? Why does she have edema from her face down to her ankles? Event Details: Stated that her arm swelled so bad that by the time she got home it looked like a little football. It was big and red hot. There was a lump there on her arm the size of a silver dollar. There was also a lump in her underarm, left groin, back of neck; lymph nodes that were as big as golf balls and are still swollen and still sore. Stated that all of her symptoms started the day of the second vaccine and are still persisting. She still has a fever and chills on and off, aches, headaches, edema, fatigue. Says she is not used to being so tired as normally she is very active. Still feels very weak. Mentions again that she can't lift her arm and has weakness and fatigue. The events required visit to Physician office. Outcome of knocked out for 2 days, couldn't eat or drink, felt unconscious was unknown. Outcome of sense of smell funny at times was recovered on Apr2021; while outcome of the remaining events was not recovered. No follow-up attempts are needed. No further information is expected.
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| 70 | 2021-01-04 | muscle pain, joint pain |
sweats; Feeling of unwellness like she had the virus or bad flu; Feeling of unwellness like she had ...
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sweats; Feeling of unwellness like she had the virus or bad flu; Feeling of unwellness like she had the virus or bad flu; could not hardly open eyes/eyes were very heavy; could not hardly open eyes/eyes were very heavy; chills; tiredness; headache; muscle pain; weakness; Joint pain; Fever; Injection site swelling and redness; Injection site swelling and redness; injection site pain; Nausea; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left upper arm, on 21Dec2020 (at the age of 70-years-old) at a single dose for COVID-19 immunization. Medical history included COVID-19 (lasted 3 weeks), high blood pressure (family history in mother and father), lumpectomy, breast cancer, radiation treatment, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, fibroid tumors, fibroid tumors surgery, thyroid problem, bone density problem, and lower lobe left of lung piece cut out (not cancer). The patient previously received chemotherapy (MANUFACTURER UNKNOWN) for breast cancer, pethidine hydrochloride (DEMEROL) for post fibroid tumors surgery and experienced swollen hands and arms, influenza vaccine (MANUFACTURER UNKNOWN) in 2020 (usually gets swelling/red arm), and oxycodone hydrochloride;paracetamol (PERCOCET) and experienced feeling sick. Concomitant medications included unspecified medications for high blood pressure, thyroid problem, and bone density problem and unspecified nasal spray, water pill, and vitamins. The patient experienced could not hardly open eyes/eyes were very heavy, chills, tiredness, headache, muscle pain, weakness, joint pain, fever, injection site swelling and redness, injection site pain, nausea, sweats, and feeling of unwellness like she had the virus or bad flu on 22Dec2020. The clinical course was reported as follows: The patient felt fine the day when injection was given, but the next day, it was like she had COVID again. She had COVID 3 months ago and it lasted for 3 weeks. It was the same symptoms she had. She could not open her eyes hardly. They were very heavy. The patient had the chills, temperature, sweats, and injection site pain (the next day). There was also swelling and redness that remained for 6 days. The patient reported that if she still puts her hand on it now, there is some sensitivity. She also had tiredness and headache. The patient reported that she only had each of these symptoms for 24 hours (as reported) and the headache was gradually improved. The patient had muscle pain and weakness. She laid down and all she could do was sleep for 24 hours. The patient had nausea for 4 days. She did not have swollen lymph nodes. The patient underwent lab tests and procedures which included blood pressure: 120/80 on an unspecified date and bone density: unknown results on an unspecified date. The clinical outcome of could not hardly open eyes/eyes were very heavy, chills, tiredness, headache, muscle pain, weakness, joint pain, fever, sweats, and feeling of unwellness like she had the virus or bad flu was recovered on an unspecified date, nausea was recovered on 26Dec2020, and injection site swelling and redness and injection site pain was recovered on 28Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
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| 70 | 2021-01-04 | muscle pain |
Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was ...
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Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was feeling very weird/ felt awful; my arm hurt; This is a spontaneous report from a contactable nurse reporting for herself. A 70-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899 (as reported: "don't know if it E or and F, looks like EH9899") & Expiry Mar2021, via an unspecified route of administration on 22Dec2020 as a single dose (age at vaccination 70 years old), for COVID-19 immunization. Medical history included pulmonary hypertension. The patient's concomitant medications were not reported. The patient had a persistent headache that doesn't go away, and had body ache (onset 23Dec2020). She reported feeling "like I had COVID." She went and got tested because she was a healthcare worker; her first test was negative (Dec2020) and her second test today (29Dec2020) was negative. She thought because it all started the day after vaccine (23Dec2020), that day she felt very sick with headache on and off, nausea, and was dizzy. She was feeling very weird and her arm hurt and she knew that she was going to have some side effect, so she went to work and took some ibuprofen (MOTRIN) for the pain and that was it. She took the vaccine on Tuesday, Wednesday she felt awful, Thursday, the only thing she had was pain in arm that's it but Friday started again with headache and all these symptoms that haven't gone away. The clinical outcome of the event persistent headache, body ache, nausea, dizzy, feeling very weird/ awful was not recovered.
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| 70 | 2021-01-06 | joint pain, muscle pain |
Was referred by Dr for evaluation of reaction to first COVID vaccine. First vaccine on 12/21/2020 Pf...
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Was referred by Dr for evaluation of reaction to first COVID vaccine. First vaccine on 12/21/2020 Pfizer-BioNTech. Administered by her place of work. Vaccine was administered in left arm. Had same symptoms as when she had COVID in 10/2020 these symptoms lasted for 12 hours. Started the following day 24 hours after vaccine administration. Symptoms include injection site redness for 6 days, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, and overall feeling of un wellness lasting 12 hours. First symptoms was eyelid heaviness and weakness. No treatment, symptoms resolved on their own. Second vaccine due 1/11/2021. Was covid positive 10/2020- no appetite, aches, chills, sweating, weakness, heavy eyelids, fatigue, ongoing for 3 weeks. Has had difficulty in the past to flu vaccines with local injection site reactions. 09/2020 flu vaccine no symptoms. Has had pneumonia vaccine with no difficulties. Has not received shines vaccine yet.
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| 70 | 2021-01-10 | joint pain |
Joint pain /felt like it was worsening joint pain; just severe pain to where she couldn't walk; This...
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Joint pain /felt like it was worsening joint pain; just severe pain to where she couldn't walk; This is a spontaneous report from a contactable Other HCP. A 70-year-old female patient received BNT162B2(Lot Number: ET1685), via an unspecified route of administration at Deltoid Left on 23Dec2020 08:00 at the 70 years old at single dose for COVID-19 immunization. The medical history included rheumatoid arthritis. The concomitant medications were none. The patient received the shot on 23Dec2020 and experienced Joint pain afterward on 02Jan2021. The patient did have rheumatoid arthritis so there was that. The patient felt like it was worsening joint pain on 02Jan2021. She has had no fever, just severe pain to where she couldn't walk on 02Jan2021. The joint pain has gotten worse and it has gotten to where she is going to advise her not to take the second shot. The Reporter assessed the seriousness for the events was Disabling. The events did not require a visit to Emergency Room but required a Physician Office visit on 06Jan2021. The patient received a steroid injection on 06Jan2021. There was none History of all previous immunization with the Pfizer vaccine considered as suspect. There was none Additional Vaccines Administered on Same Date of the Pfizer Suspect. There was no Prior Vaccinations within 4 weeks. The patient underwent lab tests and procedures, which included x-rays on 06Jan2021: unknown results (they were awaiting the X-rays). The outcome of the events was not recovered. The information on the batch number has been requested.; Sender's Comments: Based on the available information the events worsening joint pain and walking difficulty are attributed to underlying Rheumatoid arthritis; however, based on a compatible temporal association, contributory role of BNT162B2 vaccine to events occurrence cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 70 | 2021-01-11 | muscle pain, limb discomfort, joint pain |
joint and muscle pain all over; joint and muscle pain all over; She had weird dreams, very strange d...
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joint and muscle pain all over; joint and muscle pain all over; She had weird dreams, very strange dreams, and couldn't sleep; She had weird dreams, very strange dreams, and couldn't sleep; still has a problem lifting her left arm that she received the injection in; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), intramuscular on 06Jan2021 at 11:30 at single dose in left arm for covid-19 immunization. Medical history included coronavirus in Nov2020. The patient's concomitant medications were not reported. The patient reported that She had her first dose of the Pfizer Covid Vaccine yesterday at 11:30 am. She had a really bad reaction. She was fine and then all of sudden her joints and muscles hurt a lot all over. She wanted to find out what she could take for the pain. Treatment: She took aspirin. Reported she had a lot of pain, every joint and muscle hurts in her body. The pain did not start right away, she was fine at first and then the pain started all of a sudden. She had weird dreams last night and could not sleep all night. She still had a problem lifting her left arm that she received the injection in. She wanted to know if it was ok to take aspirin or something better like Tylenol. She wanted to know what she could take. Reported she had coronavirus in Nov2020. The outcome of events joint and muscle pain all over was resolving, outcome of other events was unknown.
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| 70 | 2021-01-20 | musculoskeletal stiffness, muscle tightness |
tightness of shoulders and neck; tightness of shoulders and neck; started having severe nausea in th...
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tightness of shoulders and neck; tightness of shoulders and neck; started having severe nausea in the last hour; Has a slight headache; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 08:00 in left arm at single dose for covid-19 immunization. Medical history included ongoing diabetes (she had it for 20 years), ongoing asthma (she had it for 25 years), ongoing cirrhosis of the liver non alcoholi diagnosed two years ago, ongoing hypertension diagnosed in the last three months, ongoing fatty liver diagnosed two years ago. There were no concomitant medications. Patient had Covid vaccine this morning at 8 am (12Jan2021) that was fine after 15 minutes, but patient started having severe nausea in the last hour and was unresolved by her nausea medicine. Patient had a slight headache. Patient stated that the headache which was mild, tightness of shoulders and neck started at 13:30. Patient stated that she took acetaminophen 1000 units and used a heating pad for the shoulder. Outcome of nausea was not recovered, and outcome of events were recovered on 12Jan2021. Information on the lot/batch number has been requested.
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| 70 | 2021-01-21 | joint pain |
Headache and achy feeling that night. Next day headache progressively got worse, queasy went to ful...
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Headache and achy feeling that night. Next day headache progressively got worse, queasy went to full nausea, trouble eating anything because of the nausea, aches in every joint, temperature reached 100.2 before going to bed (I almost never hit 97.2), chills. Thursday, still have milder headache, still achy all over, arms just feel heavy, temp still at 98.9. Friday, still have headache and loss of appetite, but much better
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| 70 | 2021-01-25 | back pain |
entire body felt sore; Her soreness/aching is mainly in her back, arms left deltoid, and legs; Her s...
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entire body felt sore; Her soreness/aching is mainly in her back, arms left deltoid, and legs; Her soreness/aching is mainly in her back, arms left deltoid, and legs/sore arm from the injection; Her soreness/aching is mainly in her back, arms left deltoid, and legs; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration in the left arm on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included ongoing high blood pressure, ongoing eye disorder, high cholesterol, and overweight. Concomitant medications included amlodipine, losartan, and metoprolol all from 2003 and ongoing for high blood pressure; ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS) for the eyes; and medication for high cholesterol. At night of 11Jan2021, the patient's entire body felt sore. Her soreness/aching is mainly in her back, arms left deltoid, and legs. She had a sore arm from the injection which started immediately. Outcome of the "entire body felt sore" and "soreness/aching in her arms left deltoid/sore arm from the injection" was not recovered while of the remaining events was unknown.
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| 70 | 2021-01-25 | joint swelling | Slight swelling to hands, wrists, face, tongue and neck |
| 70 | 2021-01-28 | joint pain, musculoskeletal stiffness |
by 1700 same day - lots of pain in 4rd digit on flexion and extension 8/10 - thought it was her kn...
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by 1700 same day - lots of pain in 4rd digit on flexion and extension 8/10 - thought it was her knuckle at first - couldn't grip or extend finger; now better - pain 5/10 - now can extend and grip - may be medial nerve irritation digits 3, 4, 5 a little painful but not like 4th digit slight shoulder pain at injection site
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| 70 | 2021-02-01 | muscular weakness |
Fever, headache, general achy. Than suddenly six days later intense burning, tingling, painful feeli...
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Fever, headache, general achy. Than suddenly six days later intense burning, tingling, painful feeling in both legs and feet with weakness in both legs
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| 70 | 2021-02-01 | muscular weakness |
arm soreness/Arm hurt; headache; swollen glands; head "felt stuffy"; very weak muscles (had to be he...
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arm soreness/Arm hurt; headache; swollen glands; head "felt stuffy"; very weak muscles (had to be helped to the bathroom); very weak; not feeling well; very sick; This is a spontaneous report from a contactable consumer (patient). This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 12Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 70-year-old. Medical history included Sars-Cov-2 infection (Mar2020), sick for 5 or 6 days, who knowingly has antibodies, and has donated plasma on multiple occasions, asthma but does not report respiratory symptoms, mild hypertension, migraines, vascular problems, and chronic portal vein thrombosis (PVT). Concomitant medications included linaclotide (LINZESS), hydrochlorothiazide, rosuvastatin, montelukast, levothyroxine, clopidogrel. On 13Jan2021 at night, she reports arm soreness/arm hurt, and that when she woke up the next day she 'felt like she had Covid all over again' with: headache, swollen glands, head 'felt stuffy', very weak muscles (had to be helped to the bathroom), no fever but caller did state that she took a Tylenol. From Wednesday to Saturday she didn't feeling well, but every day she felt a little better. She has asthma - drug out my peak flow meter (as reported). No asthma sx during this whole thing. She reported adverse events and thinks some might have been stunted by the Tylenol she took after the first dose. She reported she was very sick, she still had like waves of not feeling well. She had most of the symptoms that she had was when she had Covid. She was sick, she was in bed and could not move. The most severe symptoms were on 13th and slowly each day felt better and it was until Saturday was when she really started to feel a 100 percent herself. Events were reported as non-serious. She had recently lab test within the last month or so. She had two or one and blood and everything was negative, everything was normal. Outcome of very sick and not feeling well is not recovered, while the outcome of the other events is recovering. She should receive the second dose on 02Feb2021. Information about lot/batch number has been requested.
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| 70 | 2021-02-01 | muscle pain, joint pain |
Muscle aches; joint aches; exhausted feeling; slight headache; This is a spontaneous report from a n...
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Muscle aches; joint aches; exhausted feeling; slight headache; This is a spontaneous report from a non-contactable consumer (patient herself). A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on the right arm on 18Jan2021 at 12:00 PM at a single dose for COVID-19 immunization, given by the retirement home and administered at the nursing home/senior living facility. Relevant medical history included pre-diabetic, obesity, high lipids, and allergies to some psychiatric (psych) medications (meds) only. Concomitant medications included risperidone, calcium levomefolate (DEPLIN), travoprost (TRAVATAN), ibuprofen, and famotidine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19Jan2021 at 15:30 (also reported as "beginning around 3 pm"), the patient experienced muscle aches, joint aches, exhausted feeling, and slight headache mainly in the afternoon. The reporter assessed all the events as non-serious. The patient did not receive any treatment for the events. The patient was recovering from all the events. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
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| 70 | 2021-02-01 | muscle pain |
I have been having symptoms for 6 days now. Feeling very parched, especially after eating Feeling as...
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I have been having symptoms for 6 days now. Feeling very parched, especially after eating Feeling as if I were mildly allergic to what I had eaten and having the impression that upper palate was a little swollen, even if it wasn't. Mouth and upper palate always feels funny after eating making me not wanting to eat much Chalky mouth Mucous in the throat and mouth today Chills, muscle soreness, loss of appetite yesterday
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| 70 | 2021-02-03 | muscle pain |
Intestine discomfort, multiple bowel movements (no diarrhea), chills, feverish (but no fever), muscl...
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Intestine discomfort, multiple bowel movements (no diarrhea), chills, feverish (but no fever), muscle aches. I'm reporting this 24 hours after getting the 2nd Pfizer shot. Reaction started overnight. Don't know at this time how long this will last. Have not called doctor. Taking Tylenol.
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| 70 | 2021-02-04 | joint pain, muscle pain |
Fever 101 for two days. Chills sweats muscle aches and joint pain, headache, fatigue dizziness weakn...
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Fever 101 for two days. Chills sweats muscle aches and joint pain, headache, fatigue dizziness weakness, diarrhea . Had Weakness for two more days.
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| 70 | 2021-02-04 | neck pain, joint pain | Shingles. Severe pain and blisters on right side shoulder neck and head |
| 70 | 2021-02-05 | muscle tightness |
Unable to fall asleep the night of the second dose. Felt progressively worse as night went on. By ...
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Unable to fall asleep the night of the second dose. Felt progressively worse as night went on. By 3am, had fever, chills, couldn't stop shaking or get warm, had headache, skin sensitive almost hurt when touched. Felt too bad to get out of bed but eventually got up, took acetimetophen, drank water, added clothes and blankets and returned to bed. Body kept tensing up very tightly so that all muscles were constricted/tights and impossible to relax. This continued for a few hours. By morning, I thought I was starting to feel better. These symptoms returns for a second round about 2pm that afternoon and continued until about 6pm. On the nights of 2/3, 2/4 and 2/5, I wake up around 3am extremely hot and sometimes damp, despite air temp of 66 to 68 degrees. This resolves after about an hour and body feels normal.
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| 70 | 2021-02-05 | neck pain, joint pain |
My reaction began typically enough, with a sore arm and chills. The chills subsided by the evening,...
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My reaction began typically enough, with a sore arm and chills. The chills subsided by the evening, but symptoms continued and migrated from there. The arm remained sore for 3 days and then began to itch. This itchiness continued on and off for the next 2 days. My neck and shoulder were also sore. The shoulder continued to be sore for about 4 days. I had an intermittent headache, also for 4 days. The worst part though, is the nausea, which also comes and goes. But it can last for many hours and now, even after 8 days, I am still experiencing this. I can find nothing in the writings about this vaccine to corroborate this side effect and I am therefore worried about the second shot.
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| 70 | 2021-02-06 | muscle pain, joint pain |
Severe myalgia, chills, fever - flu like symptoms, fatigue, dizziness, joint pain and bilateral met...
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Severe myalgia, chills, fever - flu like symptoms, fatigue, dizziness, joint pain and bilateral meta-tarsal pain on hands (which I used to have as part of my osteopenia. But was symptomless for a while). After about 18 to 20 hours after vaccination experienced severe bilateral metatarsal pain and joint pain on knees and back. Mild to moderate nasal congestion. Took 1 gram APAP /Benadryl alternating with ASA 325mg along with bedrest. Over the course of 2 days the pain (myalgia and arthralgia), flu-like symptoms and congestion resolved.
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| 70 | 2021-02-06 | muscle pain |
chills, muscle pain, pounding headache, light-headed, fatigue lasted for approximately 24 hours. Mu...
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chills, muscle pain, pounding headache, light-headed, fatigue lasted for approximately 24 hours. Muscle aches and pounding headache w fatigue for an additional 24 hours. Fatigue for an additional 12 hours. Resolution by 4th day. Took 650 mg aspirin every 3-4 hours for first 48 hours.
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| 70 | 2021-02-07 | muscle pain |
sore throat; discharge/drainage from nose; really tired; couldn't stay awake 4 hours after, she went...
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sore throat; discharge/drainage from nose; really tired; couldn't stay awake 4 hours after, she went to bed and slept for 12 hours; muscle aches; nose was crusty; discharge from her nose, bloody/it was a little bloody; inflammation; cold; Cough; This is a spontaneous report from a non-contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 15Jan2021 at single dose for covid-19 immunization. There were no concomitant medications and medical history. She had still has a sore throat, it has been a week since her first injection, and she immediately like got a sore throat straightaway, then drainage, and she was really tired and had to go to bed in about 4 hours. She couldn't stay awake 4 hours after, she went to bed and slept for 12 hours after the first shot. There was discharge from her nose, bloody, crusty like a cold, and she seldom ever has a cold and that continued, she didn't feel good until about maybe 4 or 5 days later. Sore throat was immediately after she thinks, it was certainly the next day (16Jan2021), and her date of vaccine was 15Jan2021. Now states and cough developed not until later. On 15Jan2021, she had the shot, she was really tired, muscle aches, the kind of things on the sheet, if not that evening, but the next day (16Jan2021), then drainage, it was white at first, it didn't turn yellow until a few days later, had a yellowish tinge, so she is sure there was inflammation, and her nose was crusty, in the morning it was a little bloody, and she had a sore throat, and probably by the Wednesday or Thursday, so 20 or 21Jan2021, there was a little cough, in the evening, and she is not experiencing that today. The outcome of the event sore throat was not recovered, cough was recovered on 22Jan2021, cold was recovering, other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 70 | 2021-02-07 | muscle pain | fever of 100.5 for over 16 hours, muscle aches, fatigue |
| 70 | 2021-02-08 | joint pain |
Patient received 1st dose of Pfizer vaccine on 1/25/2021. On 2/2/2021, patient c/o right knee joint ...
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Patient received 1st dose of Pfizer vaccine on 1/25/2021. On 2/2/2021, patient c/o right knee joint pain and non-painful and non itchy circular reddened lesions on bilateral lower legs and b/l feet. No drainage of the skin noted. No fever and no flu like sx noted.
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| 70 | 2021-02-08 | muscle pain, joint pain | fatigue, headache, muscle & joint aches, mental fog |
| 70 | 2021-02-08 | muscle pain |
about 5 hrs after injection started to get headaches, during the night i felt really hot but then i ...
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about 5 hrs after injection started to get headaches, during the night i felt really hot but then i had to get extra blankets because i was freezing. Then when i woke up i had Muscle pain. Then i started throughout day i started Sneezing, watering up, coughing, runny nose. muscle pain is getting better but still have the other symptoms
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| 70 | 2021-02-08 | muscle pain | Chills muscle aches |
| 70 | 2021-02-08 | neck pain |
On 2/6/2021 woke with neck pain and droopy eyelid on the left side of the face. Went to the ER and w...
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On 2/6/2021 woke with neck pain and droopy eyelid on the left side of the face. Went to the ER and was diagnosed with Bell's Palsy.
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| 70 | 2021-02-09 | joint pain |
Vaccine was given too high, into my shoulder. Injection was only one finger width from top of should...
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Vaccine was given too high, into my shoulder. Injection was only one finger width from top of shoulder. Pain at time of injection (3:20 p.m.). Reminded me of the pain one would experience getting a cortisone shot. Three to four hours later pain in shoulder was substantial. Unable to lift arm, at all. Pain continued throughout the night. Twenty-four hours later some improvement in arm mobility and marked pain. Forty-five hours later not yet at full mobility and with slight to moderate pain. Feel more attention to vaccine injection site is needed.
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| 70 | 2021-02-09 | bone pain, muscle pain |
face looks a little bit swollen; super tired; light dry cough /Light coughing; feeling like weaknes...
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face looks a little bit swollen; super tired; light dry cough /Light coughing; feeling like weakness; bone pain; muscle ache; She had some prior ache before but today it was stronger; This is a spontaneous report from a contactable consumer (daughter). A 70-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ8982 and Expiration Date unknown) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, blood pressure high, had Corona virus before in Nov2020, and ongoing ache. The concomitant medication was reported as Lisinopril at 10 mg, one tablet a day for Blood pressure high and Vitamins. Patient woke up this morning (23Jan2021) super tired, light dry cough and face looks a little bit swollen. No just tired, she was feeling like weakness, a lot bone pain or muscle ache like a lot. The patient had some prior ache before but today it was stronger. She still feels some pain. Treatment for bone pain or muscle ache, pain was Ibuprofen. The reporter wanted to know if these symptoms are common reactions to the vaccine; if the COVID-19 vaccine can give a COVID-19 infection; if patient should receive the second dose of the COVID-19 vaccine since she was having these side effects. The outcome of events, bone pain or muscle ache, pain was not recovered. The outcome of other events were unknown. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-02-09 | weight decreased |
Sore arm; lost a bunch when she had sugery; Tremors in her hands/hands started shaking non-stop; Tre...
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Sore arm; lost a bunch when she had sugery; Tremors in her hands/hands started shaking non-stop; Tremors in her hands/hands started shaking non-stop; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 21Jan2021 at 10:40 at single dose for COVID-19 immunization. The relevant medical history included asthma, tremor (Tremors that runs on her mother's side of the family), neuropathy of hands and arms, high cholesterol, thyroid, neuropathy, vascular gait disorder, cervical stenosis operation from 2018. Concomitant medications included painkiller for neuropathy and unspecified medicines for high cholesterol, thyroid. She stated she received the first dose on 21Jan2021 and experienced tremors in her hands starting the following day. She stated that Friday her hands started shaking non-stop and had done that since then. She also reported having a sore arm. She had occasional tremors that didn't last very long. Since COVID-19 Vaccine had had nonstop shaking of hands since around Friday. Primary care doctor didn't treat her. Went to a pain center and neurologist. No further details provided. Tried to report online, but there were too many questions so she opted out. Does kind of get better if she is real still and lays down, but it still shakes. Never had this before. The patient stated that Friday or Saturday she didn't remember exactly when, sometimes they shake but not very long but this was like nonstop and it's a much more aggressive shaking. She hoped she could get the second one because she wanted the protection. She was not sure of her weight because she lost a bunch when she had surgery but she was about 115. When probed for treatment, she stated that it went away it was a day or so after but the hands were shaking and it's very intense shaking and it's going on and it's not stopping. She didn't have anything for it. It's never been like this before. The outcome of the event tremors in her hands/hands started shaking non-stop was not recovered, while other events were unknown. Information about lot/batch number has been requested.
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| 70 | 2021-02-10 | joint pain |
pain in Kidney-liver area; pain in Kidney-liver area and into right shoulder blade; pain in Kidney-l...
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pain in Kidney-liver area; pain in Kidney-liver area and into right shoulder blade; pain in Kidney-liver area; This is a spontaneous report received from a contactable consumer (herself) reported that a 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EN5318) via an unspecified route of administration in the right arm on 29Jan2021 17:15 at single dose for COVID-19 immunization. Medical history included Lymes, undiagnosed illness and CK levels doubled into the 550 level in November (unknown year). Concomitant medication was not reported. Patient was not pregnant at the time of vaccination. On 30Jan2021 07:00 patient experienced pain in Kidney-liver area and into right shoulder blade concern as her CK levels just doubled into the 550 level in November (unknown year). No treatment was received for the adverse events. Seriousness was reported as non-serious. Outcome of events was not recovered. No follow-up attempts are possible. No further information was provided.
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| 70 | 2021-02-11 | joint pain |
Approximately 15 - 30 minutes after the vaccine was administered person felt lightheaded and weak . ...
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Approximately 15 - 30 minutes after the vaccine was administered person felt lightheaded and weak . At time of injection she felt a warm sensation at the injection site and left shoulder hurt .
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| 70 | 2021-02-11 | musculoskeletal chest pain |
Arm hurt at site of shot, Very Tired, Very Thirsty (drank 3 full glasses of water in a couple minute...
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Arm hurt at site of shot, Very Tired, Very Thirsty (drank 3 full glasses of water in a couple minutes), Weak leg, (briefly, Aching, Dry eyes even with home humidifier on furnace, ribs hurt for about 5 min. and wheezing upon awakening at 4:45am, most symptoms gone by about 7:30am, Thursday.
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| 70 | 2021-02-12 | muscle pain | Injection site pain, headache, tiredness, muscle pain for 24 hours |
| 70 | 2021-02-12 | neck pain, musculoskeletal stiffness |
2/9 - Extremely sore arm at injection site. Awoke with vertigo and dizziness which seemed to subside...
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2/9 - Extremely sore arm at injection site. Awoke with vertigo and dizziness which seemed to subside somewhat as day progressed. Also had low temp 99.1 on/off throughout day and sluggishness. 2/10 - Arm still sore. However awoke again with vertigo and dizziness along with very stiff neck and neck pain that got progressively worse as day progressed. Called my family doctor late morning to report and get direction on what OTC meds I could take. Doctor returned my call after hours and recommended I go to ER to get checked and rule out meningitis since that can sometimes be side effect of vaccines with similar symptoms. ER doctor said he thought since I had Covid back in March and April of 2020, I probably still had antibodies and my immune system was fighting off the vaccine, resulting in the viral symptoms I was having. He told me I could return to taking Mobic and Tylenol (that I had been taking up to 3 days prior to vaccine) and also gave me a RX for Meclizine for vertigo.
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| 70 | 2021-02-13 | joint pain, bone pain |
I had the sho, the second, one, in the evening and I was fine. Next morning, about 14 hours later I...
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I had the sho, the second, one, in the evening and I was fine. Next morning, about 14 hours later I woke up ( 5 AM ) and my hands were really swollen, with pain in my distal joints in particular, I could not even close my hands around a spoon to put sugar in my coffee. There was pain on palpation of my bones in my hands. There was pain in my knees and my ankles. Really weird, I have no arthritis at all. However, it was the very same reaction I had when I initially took Ceclor, an old antibiotic about 20 years ago. 4 /6 hours later it had all disappeared! 24 hours after the vaccine, when I had almost forgotten about the morning, I suddenly had fever (37.9) and moderate chills! It also started from nowhere as I was watching TV at the time. I took a Tylenol and went to bed. Next morning I was fine and felt wonderful. I am a physician myself and it was really surprising for me. The arm had no pain, nothing at all, but the chills were disturbing. I am fine and happy now. I have taken ALL the vaccines available and never had a reaction like this, including rabies, and each and every vaccine I had to take. I am absolutely fine and happy and thankful.
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| 70 | 2021-02-13 | muscle pain, joint pain |
12 hours after shot - extreme migraine with nausea, sensitivity to all light, noise and movement alo...
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12 hours after shot - extreme migraine with nausea, sensitivity to all light, noise and movement along with chills, fever, muscle and joint pain - most symptoms gradually decreased over following 24 to 72 hours with acetaminophen (2-500 mg) taken every six hours over 72 hour period. Chills and headache lasting entire 72 hour period
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| 70 | 2021-02-14 | joint pain, spinal pain, muscle pain, musculoskeletal stiffness |
First day severe pain under left shoulder, 2nd my whole body hurt with muscle pain could hardly move...
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First day severe pain under left shoulder, 2nd my whole body hurt with muscle pain could hardly move. 3rd day fine 4th day muscle pain through out my body. Could not move neck. Pain down my whole spine.
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| 70 | 2021-02-14 | muscle pain |
Dose 1: mild pain at injection site Dose 2: moderate pain at injection site; fatigue, chills, musc...
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Dose 1: mild pain at injection site Dose 2: moderate pain at injection site; fatigue, chills, muscle aches, low grade fever (100), headache
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| 70 | 2021-02-15 | joint pain |
Pt initially had diffuse joint pain, then worsening pain and swelling in RLE. Had DVT u/s + for DV...
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Pt initially had diffuse joint pain, then worsening pain and swelling in RLE. Had DVT u/s + for DVT No history of blood clots, no prior risk factors Cannot be certain that she did not have clot prior to vaccine, although she never had pain or swelling to this degree (1-2 mo prior thought skinny jeans were slightly tighter on R than L, but no visible swelling. Now with RLE 2x size LLE)
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| 70 | 2021-02-15 | muscle pain, joint pain, back pain |
pt stated that right after the vax she got really bad back pain. Later that day she had muscle pain...
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pt stated that right after the vax she got really bad back pain. Later that day she had muscle pain, joint pain and fatigue. Next day she still had muscle and joint pain. On 2/15/21 she had developed a itchy rash on both elbows and later spread almost over her entire body. Pt contacted her PCP which instructed to go to the ER. She was given prednisone and Benadryl at the ER. They wrote her a rx for prednisone and she is to FU w/ PCP on 2/19/2021.
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| 70 | 2021-02-16 | muscle pain, joint pain, muscular weakness |
woke up morning after shot with headache, slight nausea, severe muscle and joint pain and muscle wea...
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woke up morning after shot with headache, slight nausea, severe muscle and joint pain and muscle weakness, could hardly sit up by myself, this was 2/11/21. I continued to feel these symptoms with lessening severity over the next 3 days until Sunday 2/14/21 at which time, late in the afternoon, I fell asleep and woke up drenched in sweat but feeling pretty much back to normal self and have felt normal self since then.
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| 70 | 2021-02-17 | joint pain |
No unusual side effects the day after my fist dose on 1/31/21 (just felt "crummy" and achy for a da...
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No unusual side effects the day after my fist dose on 1/31/21 (just felt "crummy" and achy for a day). BUT five days later I woke up with dizziness...a feeling of "disequilibrium", being "off-balance" and extreme exhaustion which lasted for five days (after three days saw a doctor who thought the two symptom might be a delayed reaction to the vaccine but of course no way to tell). Also, my right elbow (the side where I was vaccinated) has been very sore since a week after the first dose. I have had some arthritis in other joints but never the elbow. The dizziness is a lot better now (but not completely gone). Tiredness somewhat improved, elbow still quite sore. Here's my issue...I'm due for the 2nd shot on 2/21/21 and am concerned about going into it if these symptoms are still persisting. I would prefer to have the 2nd shot in my left arm but had three lymph nodes removed on that side in 2006 (when I had breast cancer on the left). Is it safe to request to have the next shot on the left arm? Should I try to re-schedule until my dizziness and joint pains from the first shot are gone? (Note: it's extremely hard to get an appt. for the Covid vaccines in my town. I don't know if an exception for me can be made by the provider.) I am worried the second dose will only exacerbate the symptoms and who knows how long they will persist. I'm normally an active, healthy 70 year old, 5'2", 152 lbs.
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| 70 | 2021-02-17 | musculoskeletal stiffness | Stiff Neck , Pain and discomfort , head fullness,pain to right and left side of face /ears |
| 70 | 2021-02-18 | joint pain | Chills, joint pain, body aches, syncopal episode, diarrhea, headache, malaise |
| 70 | 2021-02-18 | bone pain, muscle pain | muscle and bone pain, chills, irregular glucose levels, extreme confusion and disorientation |
| 70 | 2021-02-18 | muscle pain, bone pain | Chills, muscle and bone pains |
| 70 | 2021-02-18 | neck pain, armpit pain, joint pain |
Client noticed pain in her neck, left axillary and left shoulder. Had a CT scan two weeks ago that r...
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Client noticed pain in her neck, left axillary and left shoulder. Had a CT scan two weeks ago that revealed enlarged lymph nodes. Still having pain with enlarged lymph nodes today on 2/19/21. Also stated that she had a metallic taste in her mouth when receiving the first dose of the Pfizer vaccine.
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| 70 | 2021-02-19 | muscle pain | 1) Extreme fatigue; 2) Muscle ache; 3) Fever (101.1); 4) Nausea; 5) Headache. |
| 70 | 2021-02-20 | joint pain, bone pain, musculoskeletal discomfort |
Exasperated pain in osteoarthritc joints and bones. All the fingers on my right hand- normally not ...
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Exasperated pain in osteoarthritc joints and bones. All the fingers on my right hand- normally not painful, were affected. My right hip and right knee flared in discomfort, which made walking difficult. The neck ached, a dull headache resulting. And fatigue, generalized. The next day, pain diminished, fatigue continued for two days.
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| 70 | 2021-02-20 | joint pain |
RECEIVED BOTH DOSES OF PFIZER COVID19 ON 01/22/21 & 02/12/21. ON 02/21/21 REPORTED COMPLAINING OF RT...
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RECEIVED BOTH DOSES OF PFIZER COVID19 ON 01/22/21 & 02/12/21. ON 02/21/21 REPORTED COMPLAINING OF RT EAR PAIN AND SORE THROAT. HAD NEGATIVE COVID19 TEST AND FLU. NOT ABLE TO TEST FOR STREP AT THIAT TIME. DIAGNOSED WITH SORE THROAT, EARACHE ON RIGHT, AND ARTHRALGIA OF RIGHT TMJ. TOLD TO GO TO ER IF NOT BETTER IN 1-2 DAYS AND FOLLOW UP WITH PCP IN 1-2 WEEKS.
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| 70 | 2021-02-20 | joint pain |
same day: body aches, arm and foot pain subsequent days and weeks: moderate to severe pain back of r...
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same day: body aches, arm and foot pain subsequent days and weeks: moderate to severe pain back of right knee, arm pain, tingling in fingers, right foot, numbness in fingers, legs,bilateral leg pain, bloating, diarrhea, gas pain in right leg and left foot continue, diarrhea, now over 30 days after 2nd shot
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| 70 | 2021-02-20 | muscular weakness |
RECEIVED PFIZER COVID VACCINE ON 02/13/21 02/18/21 CALLED SURGERY OFFICE AND REPORTED A SWOLLEN LEFT...
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RECEIVED PFIZER COVID VACCINE ON 02/13/21 02/18/21 CALLED SURGERY OFFICE AND REPORTED A SWOLLEN LEFT LEG TO AN NP. SHE HAD AN EMG PRIOR TO CALL AND TOLD THEM ABOUT VACCINE FROM 02/13. 02/20/21 CALLED AFTER HOURS REP ABOUT COVID VACCINE REACTION 0 DESCRIBED ITCHING CERVICAL LYMPHADENOPATHY, AND WEAKNESS IN LEFT ARM, AND GENERALIZED FATIGUE. INSTRUCTE DTO GO TO THE ER. 02/20/21 REPORTED TO AND DISCHARGED TO HOME/SELF CARE WITH DIAGNOSIS OF SHORTNESS OF BREATH AND ITCHING.
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| 70 | 2021-02-20 | muscle pain, joint pain |
Flu like symptons about 4 hrs after vaccine(Thurs)...left arm, muscles, joints hurt, chills, tired, ...
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Flu like symptons about 4 hrs after vaccine(Thurs)...left arm, muscles, joints hurt, chills, tired, not feeling well. most symptoms disappeared after 24 hr however right ankle and leg continue to hurt (FRI and SAT) and by Sun. calf on right leg hot red and swollen. Mon called my physician and went to hospital for sonogram on right leg. Results were a blood clot on the back of my leg from ankle to knee. Xarelto was prescribed as blood thinner and taken. Tuesday appt. with Doctor for consultation and blood work was prescribed with follow up appointment March 2 . My concern is taking second dose of Pfizer vaccine on Mar 4. My doctor and I will discuss. On internet others have reported this same side affect of blood clots from 2 days to 2 wks after. This needs to be addressed.
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| 70 | 2021-02-21 | joint pain |
7 hours after injection, experienced extreme tiredness. Overnight, awoke with body aches, joint pai...
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7 hours after injection, experienced extreme tiredness. Overnight, awoke with body aches, joint pain, and injection site pain. Early morning awoke to body aches, headache, and extreme fatigue. While not chilled, needed three layers on top and two layers on bottom and on feet. Temperature at 8AM was 97.0. Voracious appetite and ate normally and with vigor. Slept for 3.5 hours and awoke to fever of 100.3 and voracious appetite. Ate normally. Body aches and joint pain were gone. About an hour later, temperature returned to normal but headache persisted. No longer fatigued, but still tired. Headache persisted that evening and still present at this writing, 8AM Monday.
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| 70 | 2021-02-22 | joint pain |
Sharp stabbing pains in left hip socket, approx. 3 - 5 times/hour, with buckling of left hip if walk...
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Sharp stabbing pains in left hip socket, approx. 3 - 5 times/hour, with buckling of left hip if walking. Lesser joint pains in left ankle. Gradually resolving by Day 4. Tylenol 500 mg tablet taken on Day 3 was not effective. Minor symptoms: fatigue, mild headache.
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| 70 | 2021-02-22 | back pain, joint pain |
pt stated that went to bed w/ a sore are the night after receiving the covid vax. She woke up the ...
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pt stated that went to bed w/ a sore are the night after receiving the covid vax. She woke up the next day w/ unbearable pain all over her body, body aches, joint pain, head ache, back ache. She felt like she had fever but she said it was only 99. Her left arm was swollen, red and hot around the injection site. Pt states she still has shaky, achy legs and swelling in left arm. Pt called her PCP and left message for them to give her a CB.
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| 70 | 2021-02-22 | muscle pain |
2 hrs. After injection mild chills & fatigue. 14 hrs. After injection mild chills, mild headache, ve...
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2 hrs. After injection mild chills & fatigue. 14 hrs. After injection mild chills, mild headache, very tired/fatigue, moderate to severe upper body muscle aches, mild migratory chest pains for about 30 minutes. 24 hrs after injection just overwhelming fatigue& mild headache continued for another 12 hrs. 48 hrs. After injection symptoms gone.
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| 70 | 2021-02-22 | weight decreased |
2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-g...
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2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-graded x 2 with poor appetite and recent 6lb weight loss. 2/8/21-APRN updated regarding poor appetite and difficulty chewing as well as downgraded texture of diet. Also informed of increased s/s of discomfort and increased use of PRN Oxycodone for pain. 2/9/21- elevated temp 100.7. 2/9/21 Covid pcr test negative. 2/9/21-N.O.?s APRN BMP, Albumin and Pre-albumin Level in am. 2/11/21-elevated temp 100.4. Covid rapid test negative. 2/12/21- CBG recorded at 517 at 5:20 am. Resident also has an elevated temp of 100.9. Tylenol administered per order. Vital signs include resp 24, radial pulse 134, O2 sat 83%. Supplemental oxygen administered via nasal cannula. Head of bed elevated. DR. notified at time via telephone. Order given for sliding scale for CBG. Guardian updated regarding changes in residents condition, poor prognosis. Guardian requests Hospice eval and admit. Guardian requests comfort care no hospitalization, no IV's, no G-tubes, no labs etc, D/C of Palliative services. ARNP informed. 2/12/21 Acute Telehealth visit with APRN due to increased lethargy, elevated CBG?s despite poor appetite and insulin administration. Resident unresponsive to verbal and noxious stimuli at time of visit. N.O. Morphine sulfate 20mg/ml, give 2.5mg PO/SL Q4hr PRN pain/shortness of breath. 2/12/2021-Admitted to Hospice, Lethargic, diaphoretic, T 98.1 P 130's R 18 O2 high 80's to low 90's via O2 mask at 3L. 2/12/2021- Resident legs and arms noted to feel cool this afternoon, 02 sat was 97% with 02 on @ 3L with mask Noted resident with sob and increased pulse. Prn morphine 0.25ml sl. given with good effect. Resident was less restless and quiet in her bed. Checked on resident several times this shift for needs. Resident noted to not move in her bed @ 8:15pm and noted she was not breathing. Supervisor called and pronounced resident deceased.
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| 70 | 2021-02-23 | joint pain |
The Vaccination Site is a drive thru site. People roll down the car window and are vaccinated. I a...
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The Vaccination Site is a drive thru site. People roll down the car window and are vaccinated. I am very short. The person who was injecting the vaccine was very tall. My shoulder is below the window so he injected me in the shoulder, not in the muscle of my arm. As that is what was more exposed. He should have had me stand up or he should have opened the door to inject me in the shoulder. It really hurt, and took quite a lot longer for him to inject than my first vaccination. He had to push hard to inject it. The stinging snd pain was very different than the quick first shot I received three weeks earlier and the stinging lasted an hour. I was concerned the vaccine was injected in my shoulder and sent a picture to my doctor. He confirmed it was injected in the rotator cuff. This may cause problems as reported on the CDC website as a warning to vaccinators. What do I do???
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| 70 | 2021-02-23 | armpit pain, back pain, joint pain |
arm pain in shot arm suddenly began to get worse at 10:00 pm. , severe underarm pain began then al...
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arm pain in shot arm suddenly began to get worse at 10:00 pm. , severe underarm pain began then also and found swelling like an orange, swelling lasted 8 days but was decreasing in size. became very cold and went into violent shaking tremors - 4-6 of those as i lost count. these violent tremors were from 10:30 pm on monday through 1:45 am tuesday. i had one other tremor on day 4. fever for 4 days and spiked on 5th day ranging from 101.8 - 100.3, severe all over body aching especially right armpit, lower back especially right side and across shoulders, aching lasted 8/9 days and lessened after 5 days. pressure on chest which ranged from very heavy to mild and in some form lasted 10 days, hurt to breath but i could breath. woke up on night 7 with heavy, painful chest pressure on left side but it subsided in 6-8 hours. nasty headache began day 2 and lasted several days; nothing relieved it. headache for 4/5 days and then off and on for a few days. i am not prone to headaches. coughing which lasted several days. on third day post vaccine had violent nausea one time. became weak and lightheaded. no energy and stayed in bed 5 days. on day six i started getting out of bed for several hours multiple times/day. weak and very low energy. exhausted easily. i had some of these symptoms for 10 days. the first 5 days were terrible and i was very ill.
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| 70 | 2021-02-24 | back pain |
severe back pain; unable to urinate; may have passed a kidney stone; Bladder infection; This is a sp...
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severe back pain; unable to urinate; may have passed a kidney stone; Bladder infection; This is a spontaneous report from a contactable consumer who reported for herself. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EL3247; expiry date: May2021), via an unspecified route of administration on 26Jan2021 at 12:00 (at the age of 70-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were both reported as none. The patient did not receive any other vaccines on the same date as the COVID-19 vaccination or within four weeks prior to the vaccination. On 08Feb2021 the patient experienced bladder infection and may have passed a kidney stone; on unspecified dates the patient experienced severe back pain and unable to urinate. The clinical course was reported as follows: "The patient received the first dose of the COVID-19 vaccine two weeks ago. She reported no side effects from the first dose of the vaccine; however, she was currently on an antibiotic for a bladder infection. She was scheduled to get the second dose on 16Feb2021; however, this weekend she developed a bladder infection and was on an antibiotic. She had symptoms on Sunday, and she saw her doctor on Monday. She also may have passed a kidney stone, but she was not certain. She had severe back pain and was unable to urinate." The patient read to not take any shots while taking the antibiotic. She would be off of the shot (as reported) for four days when she would get the next dose of the vaccine. The patient wanted to know "how many days would she need to be off of the antibiotic before she could get the next dose?" She stated that she would stop taking the antibiotic if she had to. She took one dose of the antibiotic on Monday and two doses today. The patient also inquired whether the side effects were different after the 2nd dose of the vaccine and how long she had to be off her antibiotics before getting her second dose of the COVID vaccine. The patient was taking sulfamethazole-TMP DS as treatment for the bladder infection since 08Feb2021. The patient sought care at the physician's office for the event bladder infection. Relevant tests were reported as none. The clinical outcome of the event bladder infection was recovering/resolving; the clinical outcomes of the events may have passed a kidney stone, severe back pain and unable to urinate were all unknown.
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| 70 | 2021-02-24 | neck pain, back pain |
did I have a heart attack. No doctor will see me to give me an EKG; Collapsed; Crushing chest pain; ...
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did I have a heart attack. No doctor will see me to give me an EKG; Collapsed; Crushing chest pain; chest was killing me and hurting and I was sobbing and it lasted about an hour and 15 minutes; Side of my neck hurt; My back hurt; It was just awful; Lethargic; I ended up vomiting for 2 days after the chest pain receded; slept for 16 hours; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 2 patients (husband and wife). This case refers to the wife with serious adverse events. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiration was not reported), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history included acid reflux. Concomitant medication included dexlansoprazole (DEXILANT) for acid reflux. Patient reported that she had terrible severe reaction on the 22Jan2021. They were vaccinated on the 18Jan2021 and on the night of the 22Jan2021, she had such crushing chest pain that she just collapsed. Her chest was killing her and hurting and she was sobbing and it lasted about an hour and 15 minutes. The side of her neck hurt and her back hurt. It was just awful. Patient reported that she have called everybody. She have called her doctor's assistant and she confused her. Patient reported that they just went in because they were 70 and 71 and got the vaccine but then she ended up vomiting for 2 days after the chest pain receded and they took baby aspirin and then she just vomited and vomited and slept for 16 hours. They were both very lethargic. She asked her what should she do. She does not know if this was a reaction to the vaccine or did she have a heart attack. No doctor will see her to give me an EKG. They say they are not seeing patients. The patient recovered from chest pain on an unspecified date; while outcome of the remaining events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021115775 same reporter/drug, similar event, different patient.
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| 70 | 2021-02-25 | joint pain |
Severe pain in left shoulder and left arm. It felt like I had ripped a muscle or tendon and would h...
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Severe pain in left shoulder and left arm. It felt like I had ripped a muscle or tendon and would hurt constantly. Pain scale of 7-9 all day and night for a week. Daly?s 6& 7 the pain did subside slightly and remain d light pain for two more days
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| 70 | 2021-02-25 | joint pain |
slight soreness on head; Knees extremely sore; passed out; fuzzy feeling; This is a spontaneous repo...
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slight soreness on head; Knees extremely sore; passed out; fuzzy feeling; This is a spontaneous report from a contactable consumer(patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809) on 10Feb2021 at 16:30 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included type 2 diabetes mellitus, hypertension and allergy to Victoza. Concomitant medications included metformin, dulaglutide (TRULICITY), atorvastatin and fluoxetine. On 10Feb2021 at 21:00 about the patient five hours after vaccine in kitchen washing dishes, passed out. No symptoms or light headedness leading up to this event. Patient woke up on floor hit head minor and knees. On 11Feb2021 the patient complained slight soreness on head, fuzzy feeling. Knees extremely sore, small cut on ankle. Her doctor adviced to report this due to the time event happened in relation to vaccine (as reported). No treatment reported for events. At the time of the reporting the patient was recovering from the events. .
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| 70 | 2021-02-25 | muscle pain |
chills starting 7 hours after shot muscle aches, headache fever 100.5 starting 16 hours after ...
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chills starting 7 hours after shot muscle aches, headache fever 100.5 starting 16 hours after shot fever of 101.4 one day following shot fever lasting 3 days along with severe headache and muscle aches
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| 70 | 2021-02-25 | muscle pain |
Pt received dose #1 Pfizer COVID vaccine 2/4/21 @ vaccine clinic. 2/8/21 @ 1155 presented to ED for ...
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Pt received dose #1 Pfizer COVID vaccine 2/4/21 @ vaccine clinic. 2/8/21 @ 1155 presented to ED for workup of myalgias, nausea, fatigue. Per ED note "chills, onset 4 days ago. Pt recently had the COVID19 vaccine and since, has been experiencing "flu like sx's" and "she feels horrible". She tried imodium, with minimal relief. Endorses abd pain, nausea, diarrhea, GERD, feeling gassy, trying to stay hydrated, decreased appetite. Denies fever, sore throat, congestion, cough, urinary sx's, SOB, CP. Patient is otherwise healthy and has no other complaints." Workup negative, prescribed zofran and discharged home without escalation of care.
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| 70 | 2021-02-26 | joint pain, muscle pain |
Severe fever chills, fever, sore arm - slightly swollen and red, which then got itchy, extreme sweat...
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Severe fever chills, fever, sore arm - slightly swollen and red, which then got itchy, extreme sweating, tiredness, slight nausea, intermittent headaches, strong muscle and joint pains, slight swollen glands in neck
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| 70 | 2021-02-28 | muscle tightness |
nervousness; slight swelling/tingling in lips; slight swelling/tingling in lips; dizziness; like she...
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nervousness; slight swelling/tingling in lips; slight swelling/tingling in lips; dizziness; like she has a cough in her throat; swelling and soreness of her arm; swelling and soreness of her arm; Tightness in her jaw; Numbness in hand; difficulty swallowing; taste in her mouth; dry mouth; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, unknown expiration), via an unspecified route of administration in left arm on 26Jan2021 at 08:30 AM at a single dose for COVID-19 immunization in a clinic. Medical history included ongoing underactive thyroid, cataract surgery on 14Oct2020 and on 28Oct2020, and cholesterol (abnormal). Concomitant medications included ongoing levothyroxine for underactive thyroid and ongoing rosuvastatin calcium for cholesterol. The patient experienced nervousness, slight swelling/tingling in lips, dizziness, like she has a cough in her throat, swelling and soreness of her arm, tightness in her jaw, numbness in hand on 26Jan2021. The patient also had difficulty swallowing, had taste in her mouth, and dry mouth in Jan2021. The patient on the line calling about the COVID-19 vaccine. She got the shot yesterday (26Jan2021) and was calling to report on the reaction that occurred. She initially stated she had slight swelling/tingling in lips, difficulty swallowing, numbness in hands, jaws became tight, and nervousness which she is still experiencing. She mentioned she took benadryl. She was wondering if she should go and get the second shot. The patient first experienced dizziness which lasted for a second and this occurred while waiting in the lobby for observation after getting the vaccine. Slight swelling and tingling in lips were noticed two minutes after the dizziness. It felt like a tingle sensation. She clarified she does not necessarily have difficulty swallowing. It was not so much she could not swallow, but it was like she has a cough in her throat. It feels like she could cough but would need to keep swallowing and drinking water. Once she got the shot it caused her to get a taste in her mouth. The feeling like a cough in her throat has gone away, but now she feels nervousness, dry mouth, and she still has that taste in her mouth from getting the shot. She had swelling and soreness of her arm, but she knew that was to be expected which started an hour after getting the vaccine. Tightness in her jaw was noticed an hour after getting the vaccine. The numbness in hand started at the same time as the tightness of her jaw. Her left hand is what went numb, and she had the vaccine administered in her left arm. The nervousness is getting better, but she felt very nervous. She also mentioned she has thyroid problems and is not sure if this has anything to do with it. She had this nervousness feeling 2 hours after getting the shot. Patient is scheduled to get the second vaccine on 18Feb2021. Benadryl has helped a lot. The patient has no additional vaccines administered on the same date and has no prior vaccination within four weeks. The events did not require emergency room and physician office visit. Vaccine was not administered in a military facility. The patient was recovering from events nervousness, slight swelling/tingling in lips, swelling and soreness of her arm, tightness in her jaw, and numbness in hand; recovered from dizziness on 26Jan2021; recovered from event "like she has a cough in her throat" on unspecified date; not yet recovered from event "taste in her mouth"; while unknown outcome for the remaining events. No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-03-01 | joint pain |
Severn pain in shoulder of injection arm. Pain did not start until at least a week after shot. No ...
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Severn pain in shoulder of injection arm. Pain did not start until at least a week after shot. No treatment sought, have applied ice and heat and have taken Tylenol.
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| 70 | 2021-03-01 | neck pain, muscle pain, joint pain |
Dizziness & slight weakness about 10-15 mins after leaving site (had to wait 15 mins before they let...
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Dizziness & slight weakness about 10-15 mins after leaving site (had to wait 15 mins before they let us drive off the site) I stopped by a convenience store to pick up a bottle of water. Severe Headache -started about 30 mins later along with tiredness and chills. Headache subsided after a few hours and then experienced extreme muscle pain in my neck and shoulders along with a feeling of malaise. Did not take any OTC drugs. Layed down in bed and tried to sleep.
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| 70 | 2021-03-02 | joint pain, arthritis |
First injection: 1 hour after injection, pain in left knee and down to ankle. Felt as though metal r...
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First injection: 1 hour after injection, pain in left knee and down to ankle. Felt as though metal rod was through knee; knee arthritic; This is a spontaneous report from a contactable consumer (patient) reported for self. A 70-year-old female patient (no pregnant) received her first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EM), via an unspecified route of administration at left arm at the age of 70-year-old, on 15Jan2021 11:30 at single dose for covid-19 immunisation. Medical history included bulging discs and allergies to penicillin. Concomitant medication included ascorbic acid (Vitamin C), colecalciferol (VITAMIN D), calcium, magnesium, biotin, curcuma longa (TURMERIC). The patient previously took hydromorphone hydrochloride (DILAUDID) and experienced allergies, sulphur and experienced allergies. One hour after first injection in left arm (15Jan2021 12:30 P.M), pain in left knee and down to ankle. Felt as though metal rod was through knee. Wore compression socks and a knee brace and did RICE to ease discomfort. At this report (2021) the patient felt knee arthritic since vaccine although intense pain subsided. No other vaccine received in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The adverse events resulted in disability. The outcome of events was recovered with lasting effects. Information on the Lot/batch number has been requested.
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| 70 | 2021-03-02 | joint pain |
wrist pain; wrist pain and it locked up.; little bumps on the back of her hand; Headache; This is a ...
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wrist pain; wrist pain and it locked up.; little bumps on the back of her hand; Headache; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EJ1686) on 03Jan2021 in the morning before 12:00 pm (at 70 years) at single dose in right arm for COVID-19 immunization.Medical history included hypertension from 2002. Concomitant medication included enalapril for hypertension from 2002 (she tried several things- unspecified-before enalapril, took a number of months before she found something to tolerate). The patient on 24Aug2015 (at 65 years) took varicella zoster vaccine live (oka/merck) (ZOSTAVAX) for immunization and experienced shingles (it started a couple months after the shot, she had skin discoloration, black spots over the skin, caused by her bathing suit and the pool water, and it stayed for about 1.5 years, she was using a cream. It was maybe 2 years before it disappeared). Patient received first dose of the vaccine on 03Jan2021, after in Jan2021, she had a headache, a week and half later pain in wrist and wrists locked up, pain floated up to the back of her hand, continued since, locking of wrist stopped, pain continued, little bumps came on the back of hand.Patient added she may have had headache the second day (as reported), it came and went, she didn't pay attention, she had a headache morning and it gone as of 15Feb2021, but still came and went. Wrists locking up recovered before 24Jan2021. Bumps on back of hand started the same time, it came and went, stayed most of last week, still had it this week, about the same.No blood tests done since this happened.Final outcome of headache was unknown. Wrists locking up recovered in Jan2021. Bumps on back not recovered. wrist pain was recovering.Patient took the second dose of the vaccine (lot EN5318) on 24Jan2021 in the afternoon (maybe 2 or 3:00PM) at single dose in left arm for COVID-19 immunization. On 12Feb2021 patient lost part of mobility in the small finger of the right hand, can't lift it all the way above. Patient was scheduled to go to the doctor on 15Feb2021 in the afternoon. Patient saw joint pain listed on contraindications, would like to know the nature of the joint pain described from side effects of the covid vaccine. She was concerned of a blood clot, unsure what happened or what can cause it, was unsure if it was muscular or something. Patient would like to know whether blood clots and muscle pain have been reported as a side effect of the covid vaccine.
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| 70 | 2021-03-02 | joint pain |
Pt c/o burning in nose area and pt reports pain, itching & burning down her left arm, which then rad...
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Pt c/o burning in nose area and pt reports pain, itching & burning down her left arm, which then radiated across her shoulders. Pt has wheezing which she reports is normal for her. BP is elevated, pt reporting not taking her meds this a.m. MD ordered breathing treatment of albuterol and metoprolol 50mg po for BP of 175/101. HR 68 SR 100%SpO2/RA,RR=21, No Respiratory Distress Noted
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| 70 | 2021-03-02 | back pain, musculoskeletal stiffness, muscular weakness, limb discomfort |
fever, chills, itching at injection site followed by severe pain in upper and lower left arm, no uri...
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fever, chills, itching at injection site followed by severe pain in upper and lower left arm, no urine output for 24 hrs, vertigo, fatigue, severe stabbing pains in face and head, stiff neck, no appetite, difficulty swallowing, pain in joints, chest pain, pain across upper back, stomach pain,. Symptoms lasted for 3 to 4 days. Severe head pain lasted 4 days. Could not raise left arm for 24 hrs after injection. After 6 days fatigue and general malaise still present. Stomach pain still comes and goes.
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| 70 | 2021-03-02 | joint swelling, rheumatoid arthritis |
the day after my first vaccination I woke with bilateral wrist stiffness and pain, bilateral ankle k...
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the day after my first vaccination I woke with bilateral wrist stiffness and pain, bilateral ankle knee and swelling in my ankles. This subsided in a few days. I was holding off on taking my Orencia infusions because I wasn't sure when I would be able to get the vaccine. Orencia dosing is every 4 weeks and I am supposed to take any vaccinations two weeks post infusion. After my second vaccination, I had a full flare. Swollen joints, IBS symptoms, fatigue,fevers, decreased appetite. I went to my rheumatologist and scheduled an infusion as soon as possible. I had to stop taking NSAIDs because my creatinine became abnormal. I had my Orencia 750mg on Februray 1, 2021, but continued to feel ill and started a prednisone
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| 70 | 2021-03-02 | musculoskeletal pain, muscle pain, joint pain |
all-over body rash that was "very red, like a tomato"; itchiness; skin was red, both sides same size...
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all-over body rash that was "very red, like a tomato"; itchiness; skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen; skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen; redness of the skin; whole body was in pain; severe allergic reaction; felt unwell; Joint muscle pain; flushed red; Tiredness; Injection site pain; joint and muscle pain; joint and muscle pain; white blood cell count on the lower side; possible damage to the kidneys; could have been possible that she had COVID and was asymptomatic, or she had it; cold; not feeling normal; This is a spontaneous report from a contactable consumer (patient) Medical information team. A 70-years-old female patient started to received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 13Feb2021 at single dose for COVID-19 immunization. Medical history included dystonia and migraines from an unknown date and unknown if ongoing, COVID-19 antibody test positive from Nov2020 to an unknown date. The patient was taking unspecified concomitant medication for dystonia and migraines. The patient experienced a "severe allergic reaction" to her first dose of BNT162B2 in Feb2021. She had all-over body rash that was "very red, like a tomato" and showed up 35-40hours after her dose. She states her doctor does not recommend she get the second dose. The patient meant by allergic reaction, she had a number of things, she experienced tiredness, injection site pain, joint muscle pain, she felt unwell, this all happened on the Saturday, the same day she got the vaccine on 13Feb2021. Then on Sunday 14Feb2021, all the symptoms she spoke about were still there and so she rested all day. On 15Feb2021, she looked at her elbows, clarifying the inside of elbow, her elbow creases, and on both elbow creases the skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen down to her thigh, it was working it's way down to the knee, the color was like a beet red, tomato color, it was under the arms, started with elbow, was at her neck. The more down the redness spread, the more it red in color it also got. When she noticed this she called the doctor. When she called the doctor, the doctor said get over to the Emergency Room right away. Her husband and her were both on the phone and were telling the doctor that she doesn't want to go to hospital, she asked if she can just come into the doctors office. The doctor said No. He told her that needs to get special lab work done, and he needs to send her information over to the ER. He said this could do possible damage to the kidneys. The doctor said lets not forget the last time she did a blood test, which was in Nov2020, at that time she came up positive with COVID antibodies. It could have been possible that she had COVID and was asymptomatic, or she had it. The doctor said that they need to do another COVID test or it could be she had a COVID cold or a cold with antibodies, her doctor doesn't know. The fact that she had that test that came back with COVID antibodies test but not have COVID in Nov2020 was something to consider. He was concerned may be there is more to this, or just a rash. The doctor said that he is not equipped say what it should be. The doctor said he will speak with them at the hospital. Tiredness subsided yesterday afternoon on 15Feb2021, it subsided before she went to the ER visit. Right now, it's kind of like a lasting effect because she is not feeling normal. The injection site pain was still there but not as bad. The joint muscle pain subsided this afternoon around 1 o clock. It first began a half hour after leaving the stadium and she was experiencing it while driving back home, the pain continued and got worse. When she got up on Sunday morning her whole body was in pain, she was not getting better on Sunday and that's when she sat on couch rest of the day. For red skin, with the temperature of the skin, she didn't feel it to see if it was hot or anything, it was more this feeling that its just not going away getting worse, it didn't feel hot, there was no texture on the skin either. She just noticed she was flushed red. She called the doctor first, and he said that he was sending information to the emergency room. Then she went to (name of place withheld) ER. They took her temperature, there was no fever. She was then relieved from the ER in 2.5 hours and went home. She still has redness on the skin. In the hospital, they gave her 40 mg of prednisone and an injection or Benadryl, and prescription for prednisone to take for the next 4 days while tapering down. She did take Benadryl about 2 hours ago, she did notice all the sudden she was getting itchy. She is less itchy now. With the itchiness, she just observed this about 2 hours ago. She took Benadryl, she has somewhat improved, she is still itchy but not to the point that she will scratch heavily. She does not have her COVID CDC Card at the moment, her husband has that information but he is on a conference call with a client and she cant disturb him. The patient was scheduled for a second dose on 06Mar2021. That's where she has a question, the doctor is saying that he is not sure about getting second shot. They took lab work at the hospital and said everything was fine except for white blood cell count, it was on the lower side in Feb2021. She has had no vaccines on the same day or in the 4 weeks prior. She hasn't had any vaccines. She did have to visit the emergency room. She only called the doctors office, the doctor said not to come in and go tot he ER. She has No relevant family medical history that she would like to share. The severe allergic reaction, "skin was red, both sides same size, then probably an hour later it was on her chest, underneath her breast, down to her stomach, past the vagina, everything was red swollen", injection site pain, redness of the skin, itchiness, joint muscle pain and whole body was in pain was recovering. The event tiredness recovered with sequelae on 15Feb2021 and the event joint and muscle pain was recovered on 16Feb2021. The outcome of the remaining events was unknown. Information on the lot/batch number has been requested.
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| 70 | 2021-03-03 | joint pain |
I received the 1st Pfizer dose on 1/30/21 and 2nd Pfizer dose on 2/20/21. After the 2nd dose, I de...
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I received the 1st Pfizer dose on 1/30/21 and 2nd Pfizer dose on 2/20/21. After the 2nd dose, I developed mild fever (under 100)*F, a bad headache, blurred vision, nausea, joint pain and fatigue. I took Tylenol for the fever and headache and recovered after 2 days. However, on 2/28/21 I developed a SECOND SERIES OF SIDE EFFECTS starting 8 days after the 2nd dose. I developed a fever of 100.7*F , a bad headache, nausea, palpitations, and severe joint pains and strong fatigue. I consulted my PCP, who recommended I fill out this report. I took Advil on 2/28, improved after 2 days, and now have a slight headache and some fatigue but otherwise recovered.
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| 70 | 2021-03-03 | armpit pain |
Woke up on day 5 (2/25) after shot with sore armpit on left side. It's day 11 (3/3) and symptoms go...
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Woke up on day 5 (2/25) after shot with sore armpit on left side. It's day 11 (3/3) and symptoms gone.
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| 70 | 2021-03-03 | musculoskeletal stiffness, neck pain |
Pain in left arm within 30 minutes of administration. General tiredness/lethargy within10 hours (upo...
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Pain in left arm within 30 minutes of administration. General tiredness/lethargy within10 hours (upon waking next morning). Sore/stiff neck within 14 hours. Body aches, chills within 16 hours. Stomach/abdominal discomfort within 20 hours. Diarrhea at 36 hours. At 36+ hours - arm pain considerably less. Body aches and chills gone by 36 hours. Continued stomach/abdominal discomfort seems to be improving after 40 hours.
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| 70 | 2021-03-03 | muscle pain, joint pain |
right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen ...
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right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen and throbbed; Right leg ankle still hurt; flu symptoms appeared; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; tired; chills; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 11Feb2021 10:00 at single dose in arm left for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medication included colecalciferol (D3) and multi vitamin. The patient did not have COVID prior vaccination. There was no other vaccine in four weeks. After about 4 hours after first Pfizer shot on a Thurs (11Feb2021), the patient experienced flu symptoms appeared, Left arm, muscles, joints hurt, chills, tired, not feeling well, on 11Feb2021 16:00. Right leg ankle still hurt after 24 hours Friday and Saturday by Sunday. Right leg calf was red swollen and throbbed on 14Feb2021 16:00. Monday (on 15Feb2021) the patient called physician and had sonogram on right leg which showed blood clot in lower back of leg from ankle to knee. Doctor put immediately on rivaroxaban (XARELTO) blood thinner for blood clot. Blood work has been done on 15Feb2021. The patient would follow up on 02Mar2021. She was concerned about taking second COVID vaccine dose on 04Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid was not tested post vaccination. The event outcome was unknown.
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| 70 | 2021-03-04 | muscle pain |
Dizziness, Hot flash starting at the base of my neck & spreading up through my head followed by swea...
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Dizziness, Hot flash starting at the base of my neck & spreading up through my head followed by sweating hands/palms followed by feeling very cold and then cycling back to hot flash, more sweaty palms, & back to chills. Minor nausea. Lasted from 8:15am til 11:30am. I called my care team at clinic they suggested that I call "911", but I did not call "911". My daughter who is a nurse came over to my house & stayed with me until 11:30am. On 03/05/2021 I woke up at 8:00am with a mild headache, minor muscle aches, tired, a little brain fog, & minor nausea which is continuing as of 10:35am as I am completing this form.
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| 70 | 2021-03-04 | neck pain |
From about 8:30pm-1:30 am I experienced chills, fever(99.6), leg aches, outer ear aches, neck aches....
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From about 8:30pm-1:30 am I experienced chills, fever(99.6), leg aches, outer ear aches, neck aches. General ill feeling. Couldn?t go to sleep. Began to feel horrible. Cold feet. Took an Advil and within 15 minutes all symptoms went away.
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| 70 | 2021-03-05 | muscle pain | Aching muscles, temp of 100.0, chills, fatigue |
| 70 | 2021-03-06 | joint swelling, musculoskeletal stiffness |
Same onset of symptoms as first dose, but different symptoms this time ( 7-8 days after shot develop...
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Same onset of symptoms as first dose, but different symptoms this time ( 7-8 days after shot developed symptoms). Trunk itches and belly fat feels like someone is squeezing it, swollen hands and feet. This time had puffy eyes and lips,with neck and genitals itching. Over my body an erythema that turns white when stroked. On my right arm, where I received the shot, very large splotch approximately 3 inches by two inches (red and swollen.) Feeling of malaise and dizzy. Stiff neck and swollen joints in fingers. Visited outpatient clinic for check up. Given Hydroxysine HCL 25mg x 3 per day. When I was in my early 30s had an anaphylactic reaction to something I ate??? Went to ER for shot of epinephrine. We never discovered what it was I was allergic to.
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| 70 | 2021-03-08 | joint pain | SWELLING AND RED RASH IN PALMS, SEVERE PAIN IN SHOULDER AND WRIST JOINT |
| 70 | 2021-03-08 | back pain |
Pfizer vaccine sudden onset dramatic sneezing and runny nose March 6-8 very painful lower back star...
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Pfizer vaccine sudden onset dramatic sneezing and runny nose March 6-8 very painful lower back started March 7 and continues as of today
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| 70 | 2021-03-08 | muscle tightness |
AT 9:30 PATIENT WAS UNABLE TO SWALLOW, MUSCLES IN NECK, THROAT AND JAW WERE VERY TIGHT; COULDNT SWAL...
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AT 9:30 PATIENT WAS UNABLE TO SWALLOW, MUSCLES IN NECK, THROAT AND JAW WERE VERY TIGHT; COULDNT SWALLOW OR SPIT. TIGHTNESS MOVED DOWN TO SHOULDERS AND CHEST. PT WENT TO ER ; STARTED SHAKING UNCONTROLLABLY, THIS STARTED AND STOPPED 3 TIMES; ALSO HAD HEADACHE, FEVER AND CHILLS, ER GAVE HER IV BENADRYL AND PT IS STILL TAKING BENADRYL.
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| 70 | 2021-03-08 | muscle pain |
At 6am I was awakened with chills, muscle aches. I took a Tylenol and went back to bed sleeping ano...
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At 6am I was awakened with chills, muscle aches. I took a Tylenol and went back to bed sleeping another 4 hours after already sleeping for 8 hours. I spent the remainder of the day with fatigue and sometimes muscle aches. I took one more Tylenol and the symptoms subsided by 6 pm that day.
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| 70 | 2021-03-09 | joint pain |
injection site pain, tiredness, headache, joint pain in knees, chills, nausea , feeling unwell week ...
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injection site pain, tiredness, headache, joint pain in knees, chills, nausea , feeling unwell week and dizzy
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| 70 | 2021-03-09 | armpit pain |
Day after 2nd vaccine, very tired, lethargic, slight headache. Day 2 Woke up with painful swollen ...
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Day after 2nd vaccine, very tired, lethargic, slight headache. Day 2 Woke up with painful swollen armpit on left side, by the evening...additional swollen and sore spot under collarbone, with a noticeable lump. (Left side also.)
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| 70 | 2021-03-10 | joint pain, muscle pain |
Hoarseness, joint and muscle aches, chills, dizziness, diarrhea. Symptoms present upon waking next d...
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Hoarseness, joint and muscle aches, chills, dizziness, diarrhea. Symptoms present upon waking next day after vaccine and have continued for 36 hours. They are unresolved at this time.
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| 70 | 2021-03-10 | joint pain |
began with fatigue; segued into body and joint aches, followed by high fever that eased down to 101....
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began with fatigue; segued into body and joint aches, followed by high fever that eased down to 101.1 by 7am. Fever totally gone by 9pm on Tuesday.
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| 70 | 2021-03-10 | joint pain |
Knee pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the...
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Knee pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the patient, reported that a 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL8982, first dose) solution for injection intramuscular on 27Jan2021 (at the age of 70-years-old) at single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. The patient experienced knee pain after the first vaccine in 2021 and her orthopedic doctor recommended an oral steroid for 6 days. The patient had a knee procedure (unrelated to vaccine) and was prescribed methylprednisolone to address the pain. MRI on an unknown date with unknown results. The outcome of the event knee pain was unknown. The consumer stated that the knee pain was unrelated to COVID vaccine.; Sender's Comments: The event Arthralgia is most likely related to an intercurrent or underlying condition which may not be related to the suspected drug BNT162B2. Knee procedure may provide an explanation for the event. The case will be reassessed if additional information becomes available.
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| 70 | 2021-03-10 | arthritis |
Inflammation in areas with arthritis, chills, fever, coughing and congestion in lungs, fatigue, dep...
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Inflammation in areas with arthritis, chills, fever, coughing and congestion in lungs, fatigue, depression, lethargy, brain fog, nausea, diarrhea, pinched nerve between should blades, swelling in both hips
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| 70 | 2021-03-10 | muscle tightness, muscle pain |
Muscle pain; Headache; Having issues breathing; could not swallow; Muscle tightness in right jaw, mo...
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Muscle pain; Headache; Having issues breathing; could not swallow; Muscle tightness in right jaw, mouth, neck, shoulder; Muscle type convulsions in neck, shoulder, arms and upper chest; This is a spontaneous report from a contactable consumer reported for self. This 70-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via intramuscular on 24Feb2021 at 10:00 AM at single dose in left arm in a pharmacy or drug store for COVID-19 immunization. The patient's medical history included high blood pressure. The patient had known allergies: anabolic steroids, many antibiotics. The patient did not have COVID prior vaccination. The patient's concomitant medications included hydrochlorothiazide, triamterene (MAXZIDE) and vitamins. At 24Feb2021 at 10:00 PM, the patient experienced muscles in neck, jaws and throat started clinching up and she could not swallow. The patient began having issues breathing. The patient was advised to go to emergency room (ER). At ER, patient started with muscle type convulsions in neck, shoulder, arms and upper chest. The patient had several episodes. Doctor administered diphenhydramine hydrochloride (BENADRYL) intravenously, did blood and urine workup. After 4 hours the shaking stopped, and the muscle contractions lessened. The patient was sent home. Next day 25Feb2021, she still had some residual muscle tightness in right jaw, mouth, neck, shoulder. On third day 26Feb2021, she had light shaking of hands and arms. The patient was still taking 25 mg diphenhydramine hydrochloride every 8 hours. She added ibuprofen (ADVIL) because she also had muscle pain and headache. The patient was recovering from the events. The patient did not test COVID post vaccination. Information on lot/batch number has been requested.
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| 70 | 2021-03-10 | muscular weakness |
Fluctuating temp, 100.3-97.5 for 5 days, muscle weakness, body aches, unsteady on my feet, nausea, n...
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Fluctuating temp, 100.3-97.5 for 5 days, muscle weakness, body aches, unsteady on my feet, nausea, no appetite, brain fog, extreme fatigue, for 8 days or more. COPD so much worse that I had to use albuterol twice a day which I didn't use before lasting 2 weeks. No daily walk for 2 weeks because I couldn't balance properly. Sweats and chills not corresponding to temp fluctuation 2 weeks. Night sweats which I have never had before EVER. My scleritis kicked in really bad, worse than ever before. I still don't feel well 19 days later
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| 70 | 2021-03-10 | muscular weakness |
Numbness and weakness in the right leg that began the night of receiving the 2nd Pfizer covid vaccin...
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Numbness and weakness in the right leg that began the night of receiving the 2nd Pfizer covid vaccination. It has continued to the present day.
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| 70 | 2021-03-11 | joint pain, joint swelling | Joint Pain and swelling primarily on feet, ankles and sometimes knees intermittently |
| 70 | 2021-03-11 | joint pain |
Injection site pain Headache with ?brain zaps? for a period of 2+ hours Joint pain over entire body ...
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Injection site pain Headache with ?brain zaps? for a period of 2+ hours Joint pain over entire body Chills with severe trembling Fever Vomiting for a period of hours Severe itching on my back, shoulders and upper arms for two days
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| 70 | 2021-03-11 | joint pain |
Pancreatitis, mild. In addition had fever/chills, nausea, headache, joint pain all in first 24 hour...
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Pancreatitis, mild. In addition had fever/chills, nausea, headache, joint pain all in first 24 hours.
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| 70 | 2021-03-12 | neck pain |
Headache, left ear -deep pain, right pain up my neck to my jaw. Chills-couldn?t get warm . Achy all ...
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Headache, left ear -deep pain, right pain up my neck to my jaw. Chills-couldn?t get warm . Achy all over . Extremely tired. Don?t know if I had a fever-no thermometer. Started feeling sick around 4 am Thursday morning, chills & rest of symptoms about 8. Chills stopped around 4:30pm. Headache lasted through Friday. Friday night feeling pretty well. Just tired
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| 70 | 2021-03-13 | armpit pain | Headache, nausea, heartburn, chills, pain in arm pit on same side as shot was given and tiredness. |
| 70 | 2021-03-13 | armpit pain |
12:15 a.m. Horrific headache, horrible body shakes and chills High fever, extreme fatigue, sore th...
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12:15 a.m. Horrific headache, horrible body shakes and chills High fever, extreme fatigue, sore throat, extreme pain in armpit Fluids, advil, lots of sleep. Still fatigued
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| 70 | 2021-03-13 | muscle pain |
Felt hot (did not take temp) then had shooting pains through muscles, mostly extremities. This last...
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Felt hot (did not take temp) then had shooting pains through muscles, mostly extremities. This lasted approximately 6-8 hours, then abated. Afterwards felt weak for about 12 hours.
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| 70 | 2021-03-13 | neck pain |
Flu like symptoms. Chills and hard body shakes that I could not control until I finally got warm, b...
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Flu like symptoms. Chills and hard body shakes that I could not control until I finally got warm, body aches, especially back of head and neck, extreme tiredness, I already have post covid tiredness, but this tiredness is worse than the post covid tiredness. I have been in bed since it started at 4 am Saturday, March 14, 2021
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| 70 | 2021-03-14 | bone pain |
syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; sor...
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syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; soreness, redness, and pain at injection site; her blood pressure was really high and kept going up and down like a roller coaster; She was taken to the ER and began feeling sick to stomach in ambulance; headache; felt her ears vibrating; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; She is anxious about getting the second vaccine; Enlargement of lymph nodes; increased heart rate; This is a spontaneous report from a contactable Nurse reported for self. This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 on Arm left at single dose (Lot # EL9262, Expiration: May2021) for covid-19 immunisation. Medical history included Atrial fibrillation from Jan2020. Had 2nd dose appointment scheduled but canceled appointment. Concomitant medications included apixaban (ELIQUIS) from 07Feb2021 at 5mg twice a day by mouth (provided SN100089537925, LOT 1771228, EXP: May2023, NDC: 0003-0894-21) for Atrial fibrillation. History vaccine included a Tetanus shot 40 years ago (1981) for immunisation and reacted terrible to it. She reports having and experienced soreness, redness, and pain at injection site. She reports getting a mammogram sometime after receiving the vaccine. They saw a spot they are going to recheck and saw swollen lymph nodes on the left side/ Enlargement of lymph nodes, which is the same side she received her vaccine. She was told it was most likely due to the vaccine. Six days later she suddenly felt sick, near syncope, couldn't catch her breath. It got so bad she thought she was dying and called EMS. Leads confirmed afib, her blood pressure was really high and kept going up and down like a roller coaster. She was taken to the ER and began feeling sick to stomach in ambulance. IN the ER she received 1000 ml of fluids and additional metoprolol in addition to dose she took that evening at home. She was sent home to follow up with her Cardiologist the following Monday. He wasn't sure if it was due to vaccine and started her on twice daily eliquis and increased her toprolol immediate release to twice daily. The following Friday night she got a headache and felt her ears vibrating. Her home EKG was fine, but blood pressure was high again and stayed up for hours. Took additional toprolol. Came down after 5 hours. Breast, arm and clavicle starting hurting two weeks and one day after the injection. She is anxious about getting the second vaccine. Asked PCP if she needed an antigen test to see if she needed a second dose of the vaccine. She says she got her first dose 01Feb, then on Wednesday, 03Feb she went and got a mammogram which had already been planned. She says that they saw enlarged lymph nodes to her left breast, under arm, and clavicle which they said are due to vaccine, but they also said they saw something else so they wanted to do a repeat mammogram three months later. She says it took two weeks, but suddenly her left breast and under arm were killing her, caller did not clarify this statement. She says she talked to her doctor who said don't worry it might take a while to go down. She says that the other thing is she has known atrial fibrillation that was diagnosed a year ago, and most of the time it is quick and doesn't last long, sometimes she doesn't know she is having it. She says 6 days after the first dose she started to feel ill, she had been in bed reading so she got up to get some water and suddenly felt like something was wrong and like she was going to pass out, she couldn't breathe, so she called EMS. She says her atrial fibrillation is not unusual, but she has never had it to where she couldn't breath. She says that the rate they estimated was 350, and her only other documented that was high like that was 150. She says that they treated her and she went home, and when she saw her cardiologist they said they don't know if the vaccine had to do with this, and to report it. She says a week later, on Friday a week ago, she started feeling funny standing while she was working on the computer in the middle of the afternoon, she felt like her ears were vibrating, which was very unusual, and she didn't know what was wrong so she looked at her Cardia app, and her heart was in normal sinus, and she checked her blood pressure which for her was sky high, up to 190/100 which her blood pressure is usually very low. She provided a second blood pressure that call handler was unable to capture and caller did not clarify as she no longer had her log with her. She says for hours her blood pressure (BP) went up and down, which was a similar or same thing as what happened that night she went to the ER with her atrial fibrillation, her BP would go up and down like riding a wave. She says needless to say, she has two questions: she says she doesn't know if there have been reports of that vaccine making A-fib worse, she is scared to get her second dose which she was supposed to get Monday a week ago, but put off primarily before the second thing with BP, she thought she would wait because she could hardly move her left arm so she put it off until the next Wednesday, She says that her second dose is now scheduled for 03Mar, so 4 weeks between doses, and she is a little afraid to get it because she doesn't know if her response was over the top or caused the other things, going to the ER with A-fib was terrifying, and she doesn't want that to happen again. She says people say that she has got to get her second dose because she won't be protected, so she would also like to know if it is possible for her to get antigens early on. She says that she had a tetanus shot 40 years ago, and had a horrible reaction after it, then years later they did a titer for tetanus and they said she would likely never need a tetanus shot again since she had built up such a high level and would never need it again. She says is it possible that she had enough immunity that she wouldn't need the second dose, or would there be an antigen test that could tell her if she would need a second dose, if so what is that test? She says she is afraid the next dose will kill her. AE treatment included says that when she went to the ER it was about 12:30AM when she arrived, they did not admit her. She says on the way to the ER in the EMS truck they gave her Cardiozyme to get her blood pressure going down and gave her 1000 cc fluids, and Metoprolol, another dose. She says that the Cardiozyme was IV push in the ambulance, she doesn't have the information to provide for all of the heart stuff they gave her, NDC/LOT/EXP: Unknown for Metoprolol or Cardiozyme. She clarifies that she takes Metoprolol normally every day that they have had her on that is extended release and she takes it at night. She says she had taken that at 09:30PM, and by the time she got there to the ER after midnight a little, they after gave her another to see if it would bring her heart rate down. She says that they kept her there a couple of hours, until her heart rate was normal, though her BP was up a bit. She says that they told her they could admit her but she said she would rather go home if they thought it was safe, and she went home. She says that her sister came home and stayed with her, whose husband is a cardiothoracic surgeon. Metoprolol: Caller says that the Metoprolol she is taking is in a pharmacy bottle that says use by 08Feb2022, it does not have an official label, the NDC or LOT are not on there. She says that they gave her 60 to take of regular Metoprolol, not extended release, which is 25mg to take twice a day by mouth, so 60 tabs and she would need to get refills as it is a months worth. Metoprolol extended release NDC/LOT/EXP not provided when queried. She clarifies that the not extended release is called Toprol/Metoprolol Tartrate 25mg. Caller says that her swelling lymph node limited the use of her arm, she can't pick up anything or lift her self up while moving in the bed, she is miserable, it hurts to put pressure on her arm and she can hold her arm up and move it around she can do anything with not holding anything, she feels a tightness there, even when she breathes or coughs. She says her left arm was sore initially for 3-4 days after getting the shot but the soreness left. She says she was told on 03Feb that she had swollen lymph nodes, which was two days after the shot, but she couldn't feel them then, she couldn't tell, and had no pain. She says it was two weeks later that happened, it was so odd that it was two weeks before it was hurting then got progressively worse. Caller says that Tuesday a week ago she thought she must have done weights with her arms since her muscles were sore, but it was only on one side and she hadn't done any exercise since after she went to the ER she was being careful what she did, and she thought she strained her arm and realized what it was, it has gotten progressively worse over the last week. She says last night she started looking up remedies, she has been putting ice on it, and the clinic said use warm, and she rubbed castor oil on it last night in the shower then this morning she massaged her arm with castor oil and put a warm wash cloth over it. She says that castor oil has anti inflammatory properties. She says she has not noticed a difference yet, but she has only done it two times. She says it also said she can take Aleve or Ibuprofen, they told her at the ER, they also started her on Eliquis the night she was there, which she had never been on, they didn't consider her A-f fib bad enough. She says that is what has her concerned, she got the shot then 6 days later A-fib made her feel like she couldn't breathe. She says also her BP and heart rate going back up made her sick to her stomach that subsided when her BP was coming down but then it started going back up again, when she went to the ER that Saturday night on the 6th but by the time she got there it was the 7th. Outcome of the events was unknown.; Sender's Comments: The possibility that suspect drug may have contributed to the reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 70 | 2021-03-14 | muscle pain, joint pain |
Pain and swelling at injection site - unable to raise arm above head Treated with Tylenol. Resolve...
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Pain and swelling at injection site - unable to raise arm above head Treated with Tylenol. Resolved in 36 hours. Severe generalized headache, myalgia, arthralgia, extreme fatigue, loss of appetite, but no fever. No analgesic helped symptoms. Required bedrest for three full days. Symptoms resolved after four days.
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| 70 | 2021-03-14 | muscle pain |
Chills; fever; extreme fatigue; muscle achiness; headache; swollen arm; rash on arm; This is a spont...
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Chills; fever; extreme fatigue; muscle achiness; headache; swollen arm; rash on arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot#: EN6202, expiration date unknown) on 23Feb2021 at 12:15 AM at the age of 70-year-old at single dose via an unspecified route of administration at left arm for COVID-19 immunization. Patient was not pregnant at time of event and at the time of vaccination. Medical history included allergy to sulfa. Patient previously received 1st dose of BNT162B2 (Lot#: EL9264) on 02Feb2021 at 02:00 PM at the age of 70-year-old at left arm for COVID-19 immunization. Concomitant medications included raloxifene, fish oil, ergocalciferol (VIT D) and calcium. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced chills, fever, extreme fatigue, muscle achiness, headache, swollen arm, rash on arm; all on 23Feb2021 at 15:00. Outcome of the events was recovering. No treatment was received for the events. Events were reported as non-serious. Events didn't result in emergency room visit or physician office visit. No seriousness criteria was reported: no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.
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| 70 | 2021-03-14 | neck pain, joint pain |
Fever to 101.3 F approximately 24 hours after vaccination. This resolved with over-the-counter feve...
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Fever to 101.3 F approximately 24 hours after vaccination. This resolved with over-the-counter fever reducing medication (not specified by patient). Brief neck pain and arthralgias in the arms and legs also on the day following vaccination. These resolved spontaneously. She was asymptomatic 48 hours after vaccination.
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| 70 | 2021-03-15 | joint pain, arthritis, joint swelling |
I woke up the morning after receiving the second Pfizer Covid-19 vaccine, and the ball joint and toe...
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I woke up the morning after receiving the second Pfizer Covid-19 vaccine, and the ball joint and toe of my left foot was swollen, red and painful. I ended up taking methylprednisolone (Medrol Dose Pac) for it. A few days after I completed that course of medication, I had another reaction where the left ankle did the same thing, got blood tests and the joint was aspirated; the doctor injected lidocaine and a corticosteroid into the joint, also the Medrol Pac meds again. Seems to be okay now. My doctor considers it a flare of inflammatory arthritis, auto-immune.
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| 70 | 2021-03-15 | muscle pain, joint pain | Joint and muscle pain (Hips, Knees, Feet, toes, Hands, fingers, ankles), tired, and headache |
| 70 | 2021-03-16 | joint pain |
Headache, stomach ache dizzy nausea pain in shoulder very sore , blood sugar dropped to 60, blood...
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Headache, stomach ache dizzy nausea pain in shoulder very sore , blood sugar dropped to 60, blood pressure 185 systolic; has not been to doctor yet
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| 70 | 2021-03-16 | joint pain |
Symptoms: Headache, nausea, body and joint ache, fever. Treatment: Tylenol and bed rest Time c...
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Symptoms: Headache, nausea, body and joint ache, fever. Treatment: Tylenol and bed rest Time course: 18 hours and continuing.
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| 70 | 2021-03-16 | back pain |
Shingles outbreak involving dermatomes T10-12 on right side. Began two days after vaccination with d...
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Shingles outbreak involving dermatomes T10-12 on right side. Began two days after vaccination with deep pain and hives initially, resulting in typical herpes zoster rash about 6 days later. On the third day of the rash, began Valacyclovir 1gm PO TID. Is still symptomatic; rash has not yet resolved.
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| 70 | 2021-03-16 | muscle tightness, musculoskeletal chest pain |
She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/p...
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She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/pain and tightness in both jaw lines was reported as worsened; I do have migraine; Hives; this is just a nightmare if this is not a normal problem; Can't think; pain and tightness in both jaw lines; pain and tightness in both jaw lines; thrush; proverbial headache/When I bend over I have a blinding headache; no coordination; Vomiting projectile/Throwing up right away; arm was hurting; swelling in arm; Chills; uncontrollable bladder gushing leaking; shaky arms; unable to eat anything; has been as sick as a dog; non stop coughing; Rib pain; This is a spontaneous report from a contactable consume. A 70-years-old female patient received bnt162b2 (BNT162B2) , via an unspecified route of administration on 2Feb2021 as a single dose, for covid-19 immunisation . Medical history included arthritis from 1992 and ongoing Verbatim: Arthritis , fibromyalgia from 1994 and ongoing Verbatim: Fibromyalgia , gastrooesophageal reflux disease from 1992 and ongoing Verbatim: GERD , lactose intolerance from 1992 and ongoing Verbatim: Lactose intolerance , depression from 1994 to an unknown date Verbatim: Anxiety depression , hypertension from 1992 to an unknown date Verbatim: Blood pressure high , MRSA , water pollution from an unknown date and unknown if ongoing She was unable to drink anything except sips of cold water and eat a few ice chips. She is unable to drink lukewarm water. This was prior to getting the vaccine , surgery from an unknown date and unknown if ongoing She had 22 surgeries in 4 years on her left eye. It started with pressure testing then infections. The patient reported she is legally blind in her good eye, has been as sick as a dog, non stop coughing, , non stop coughing , thrush on 23Feb2021, proverbial headache/when i bend over i have a blinding headache, , no coordination, vomiting projectile/throwing up right away arm was hurting, swelling in arm chills, uncontrollable bladder gushing leaking pain and tightness in both jaw lines unable to eat anything can't think felt like crap. The outcome of the events: Unknown: blindness, thrush, shaky arms, unable to eat anything, Can't think, Felt like crap, I do have migraine; Recovered, vomiting, swelling in arm; Recovoring illness, cough, rib pain, Not recovered headache, no coordination, uncontrollable bladder gushing leaking, pain and tightness in both jaw lines, pain and tightness in both jaw lines; Chills recovered with sequelae.
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| 70 | 2021-03-16 | muscle pain, joint pain |
Chills, muscle aches, joint pain starting about an hour and a half after getting the vaccine, and la...
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Chills, muscle aches, joint pain starting about an hour and a half after getting the vaccine, and lasting for 3 days.
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| 70 | 2021-03-17 | back pain, musculoskeletal pain, joint pain |
Before vaccination I was experiencing slight sciatica pain in right lower back and buttock. The mo...
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Before vaccination I was experiencing slight sciatica pain in right lower back and buttock. The morning (6:00 am)after the vaccination I got up and could hardly walk because of excruciating pain in right lower back and buttock. I started taking a muscle relaxant and Ibuprofen for the pain. Some days were better than others and after a week I started feeling better with no pain. I also had right wrist pain (I had surgery on my right wrist Dec/ 31, 2020 for a cyst removal.) I had trouble moving my right wrist. I still have some wrist pain, especially in the morning. It subsides somewhat after using it during the day. My lips started peeling a couple of days after the vaccination. I used a lip balm several times daily It took a week for my lips to return to normal. I am feeling well now and am glad to have received the vaccination.
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| 70 | 2021-03-17 | muscle pain |
Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swe...
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Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, feeling unwell, swollen lymph nodes Had these side effects for 24 hours, but the injection site swelling has lasted for a week. Took tylenol for the side effects and it helped.
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| 70 | 2021-03-18 | back pain | Back ache, chills, vomiting and diarreau |
| 70 | 2021-03-18 | muscular weakness, musculoskeletal chest pain |
have some trouble sleeping; feelings of anxiousness, anxiety; Eyes dry; Ribs hurting; Wheezing; Arm ...
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have some trouble sleeping; feelings of anxiousness, anxiety; Eyes dry; Ribs hurting; Wheezing; Arm started hurting; Very tired; Very thirsty; One of legs got weak; achy; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9261), via an unspecified route of administration, in the right arm on 10Feb2021, 12:15 at a single dose for covid-19 immunization. The patient's medical history included ongoing Hashimoto's Hypothyroidism from 2000 (had it at least five years before a diagnosis), allergies year-round, depression, pneumonia, wheezing, calcium deficiency from an unknown date and unknown if ongoing. Concomitant medication(s) included thyroid (ARMOUR THYROID) taken for Hashimoto's Hypothyroidism from an unspecified start date and ongoing; bupropion hcl (BUPROPION HCL) taken for depression from an unspecified start date and ongoing; loratadine (LORATADINE) taken for allergies year round from an unspecified start date and ongoing; aspartate calcium, aspartate zinc, calcium ascorbate, glucosamine sulfate, magnesium aspartate, manganese aspartate (BONE STRENGTH) taken for calcium from an unspecified start date and ongoing; carbinoxamine maleate (OMEGA 100), colecalciferol (VITAMIN D3), chondroitin sulfate, collagen, glucosamine (COLAGEN) taken for an unspecified indications from an unspecified start dates and ongoing. When she was older the patient was given the high dose Flu Vaccine and had this reaction where her arm was red from shoulder down to elbow. After that she told them not to give her the high dose Flu Vaccine. She gets the regular Flu Vaccine. She assumes it occurred year turned 65, but was not sure. She does not have a lot/exp/NDC to provide. The patient experienced arm started hurting and very tired (around 7:00-7:30), very thirsty (had to drink three tall glasses of water back to back, reported she was never that thirsty), one of legs got weak (for a brief moment one of her legs was very weak and noticed while walking from the living room to the bed room) and achy on 10Feb2021. It was reported that the patient took a bath with Epsom Salt and it id not help. She got in bed by 8PM. Normally she goes to bed around 9:30-10 PM, but she was very tired. She then followed up and stated she went to sleep after the news about 10:20. Then at 4:45 AM she woke up because her eyes were very dry. Stated she has a humidifier in the apartment and usually has no trouble with her eyes, but they were very dry. She also noticed her ribs were hurting and it was noticeable on 11Feb2021. She was also more achy, but it the ribs hurting did not last real long. Then she noticed she was wheezing (11Feb2021). She knows she was wheezing because she has had pneumonia in the past and had wheezing then. The wheezing she had after the vaccine was not real bad. It stopped after about 10-15 minutes or so. She had laid down in bed for a while then got up around 5:30 AM. She felt better around then, but it took until like around 8AM before she felt fully okay as her arm was still aching. The outcome of the event arm started hurting and achy was recovered on 12Feb2021; eyes dry, ribs hurting and wheezing recovered on 11Feb2021; thirst and muscular weakness recovered on 10Feb2021, and unknown outcome for the remaining events.
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| 70 | 2021-03-18 | neck pain |
I had minor side effects on January 28, 2021 first dose. My second dose was February 15, 2021. I cal...
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I had minor side effects on January 28, 2021 first dose. My second dose was February 15, 2021. I called an ambulance at about 2:00 am on February 18, 2021, with severe pain on the left side of my face and left neck. The pain in my teeth felt like it was being drilled. I was nauseated and the ambulance people thought I was having a heart attack. My blood pressure is normally 110/65, but it was close to 200/104, I think they said. A few days later I went to another ER because the doctor thought I was having a stroke.
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| 70 | 2021-03-20 | muscular weakness |
8 days after receiving 1st vaccination Lightheaded, dizzy , weakness in legs Feels like Cotton i...
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8 days after receiving 1st vaccination Lightheaded, dizzy , weakness in legs Feels like Cotton in my brain Fog brain Lethargic, malaise
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| 70 | 2021-03-20 | musculoskeletal stiffness | Severe headache Stiff neck |
| 70 | 2021-03-20 | muscle pain, joint pain |
fatigue; headache; muscle & joint aches; muscle & joint aches; This is a spontaneous report from a c...
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fatigue; headache; muscle & joint aches; muscle & joint aches; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of BNT162B2 (BNT162B2, product: COVID 19, Pfizer- BIONTECH, Solution for injection, Lot number: 9269) via an unspecified route of administration, administered in Arm Left on 06Feb2021 10:30 as single dose for covid-19 immunisation. Medical history included hypertension (controlled) and irritable bowel syndrome. Known allergies was none. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), verapamil, spironolactone (ALDACTONE) and losartan all are via unspecified route from unspecified date at unspecified dose and frequency for unspecified indication. Facility type vaccine: Other, if other vaccine in four weeks, COVID prior vaccination and COVID tested post vaccination reported as no. historical vaccine included first dose of BNT162B2 product: COVID 19, Pfizer- BIONTECH, Lot number: 8982 on 16Jan2021: 02:00 PM unspecified route Left arm for COVID-19 immunization. The patient experienced fatigue, headache, muscle and joint aches on 06Feb2021 14:30. Patient received treatment for AE reported as no. The outcome of the events was resolved on an unspecified date in Feb2021.
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| 70 | 2021-03-20 | muscle pain |
lethargy; Chills; fever; muscle soreness; Major headache; nausea; Bad reaction at injection site; Th...
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lethargy; Chills; fever; muscle soreness; Major headache; nausea; Bad reaction at injection site; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810), via an unspecified route of administration, administered on the Left arm on 04Feb2021 14:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history was none. If other vaccine in four weeks: No. Other medications in two weeks: no. Other vaccine same date details: other vaccine same date dose number was 2. Facility type vaccine was Hospital. If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. The patient experienced lethargy, chills, fever (pyrexia), muscle soreness (myalgia), major headache (headache), nausea and bad reaction at injection site (injection site reaction); all (non-serious) on 04Feb2021 17:30. Adverse event: Chills, fever, muscle soreness, major headache, nausea, lethargy, bad reaction at injection site. There was no treatment for AE. The outcome of events was recovered on an unspecified date in Feb2021..
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| 70 | 2021-03-21 | joint pain, muscle pain |
Morning after 2nd dose: Tiredness/ fatigue, chills, muscle soreness, joint pain and stiffness. Last...
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Morning after 2nd dose: Tiredness/ fatigue, chills, muscle soreness, joint pain and stiffness. Lasted about 36 hours. Took naproxen 375 mg which seemed to help
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| 70 | 2021-03-21 | joint pain, muscle pain |
Over a period of 4.5 days, fever, fatigue, joint pain, muscle pain, loose stools, general malaise ...
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Over a period of 4.5 days, fever, fatigue, joint pain, muscle pain, loose stools, general malaise My concern is that now post 23 days after 2nd vaccine, I?m still having fatigue, no endurance, mild/moderate body aches, worse at night, still some episodes of loose stools.
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| 70 | 2021-03-21 | bone pain |
First event - Rash on chest and torso 2 days after vaccination (3-10-21). Slight itchiness. Went awa...
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First event - Rash on chest and torso 2 days after vaccination (3-10-21). Slight itchiness. Went away after about 2 days. Second event - rash on beck and arms, aching in bones 2 weeks after vaccination (3-22-21). Went away after a few hours.
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| 70 | 2021-03-21 | muscle pain |
Left arm extremely tender, arm and leg muscles sore, low grade 99.2 temp and massive headache fro...
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Left arm extremely tender, arm and leg muscles sore, low grade 99.2 temp and massive headache from nose to back iofhead
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| 70 | 2021-03-21 | muscle pain |
The day following the vaccine, I experienced a sore left arm. Ten days following the vaccine, I bega...
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The day following the vaccine, I experienced a sore left arm. Ten days following the vaccine, I began having extreme fatigue and muscle aches throughout my entire body. I felt inflamed. The fatigue impaired my ability to walk and do normal activities. I mostly wanted to sleep. At first I did not associate the symptoms with the vaccine, but then realized it was probably associated. The fatigue and muscle aches lasted about 7 or 10 days.
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| 70 | 2021-03-22 | joint pain |
nauseous, swollen lymph nodes under right armpit, chills, fever of 102, joint pain. 5 days later sa...
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nauseous, swollen lymph nodes under right armpit, chills, fever of 102, joint pain. 5 days later same symptoms
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| 70 | 2021-03-22 | armpit pain | Slight headache, chills, fever of up to 101.6 for 3-4 days & very painful underarm ! |
| 70 | 2021-03-23 | back pain, neck pain, joint pain |
Woke up the next morning with intense body aching from head, neck, shoulders, arm, spine; lightheade...
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Woke up the next morning with intense body aching from head, neck, shoulders, arm, spine; lightheaded, fatigued, and weak all day, no fever, took ibuprofen that evening (day after vaccine), and symptoms resolved by the next morning.
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| 70 | 2021-03-23 | muscle tightness |
Tremor of R hand already had Essential Tremor of L Hand. Tremulous cheeks occ when smiling if movin...
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Tremor of R hand already had Essential Tremor of L Hand. Tremulous cheeks occ when smiling if moving head downward. Lower ext feeling tense quads, gluteus Maximus and chin feeling tremulous
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| 70 | 2021-03-23 | rheumatoid arthritis |
1015 Received vaccination 1045 Developed left sided headache, right sided facial droop and perioral ...
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1015 Received vaccination 1045 Developed left sided headache, right sided facial droop and perioral paresthesias 1046 Evaluated by medical control; vital signs include BP 160/90, pulse 55, respirs 14/minute, O2 sat 98% RA. With smile right side of mouth lower and asymmetric compared with left, confirmed by husband. Nonfocal neuro exam otherwise with normal neurosensory and eyebrow/forehead motor 1055 Reevaluated with similar findings 1100 Ambulance called 1115 Ambulance arrived for transport
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| 70 | 2021-03-24 | joint pain, muscle pain |
Exacerbation of fibromyalgia symptoms. Severe muscle and joint pain. Headache. Increased fatigue t...
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Exacerbation of fibromyalgia symptoms. Severe muscle and joint pain. Headache. Increased fatigue times four days.
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| 70 | 2021-03-24 | back pain |
Patient presented 2 days after injection with bilateral lateral chest pain radiating to back, interm...
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Patient presented 2 days after injection with bilateral lateral chest pain radiating to back, intermittent, sometimes at rest and sometimes with walking. Had previously been walking 2 miles twice daily, found extreme fatigue stopped her from walking more than 4 blocks with onset at same time. Evaluation included normal CBC w/ diff, ESR, CRP, CMP, LFTs. With pain no better, further eval 3/12 included RUQ U/S ddimer, NT-ProBNP. US showed dilated IVC and hepatic veins, EKG showed only bradycardia at HR 47. Patient eventually agreed to admission, workup for ACS negative with normal echo, clear coronary angiogram. Continuous monitoring showed severe bradycardia with episodes in 20s, pain improved with nitroglycerine. Pa
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| 70 | 2021-03-24 | weight decreased |
I had a horrible reaction to the second shot of Covid 19; I really thought I was going to die; It wa...
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I had a horrible reaction to the second shot of Covid 19; I really thought I was going to die; It was so bad; that's how bad that was; I woke up with the migraine headache, I never had a migraine; I had complete chills; I had a bad fever; I had complete exhaustion; my whole body hurt; I had complete exhaustion; my whole body hurt; I started vomiting, I had repeated vomiting; I just could not feel any worse; No, I just don't feel great yet, I lost 5 pounds truthfully; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 16Mar2021 (at the age of 70-years-old) as single dose for covid-19 immunization. Medical history included thyroid disorder (thyroid). Concomitant medication included thyroid (NATURE THROID) for thyroid. On 17Mar2021, the patient experienced that she had a horrible reaction to the second shot of COVID 19; she really thought she was going to die; It was so bad; that's how bad that was; the patient woke up with the migraine headache, she never had a migraine; the patient had complete chills; the patient had a bad fever; the patient had complete exhaustion; her whole body hurt; the patient started vomiting, she had repeated vomiting; she just could not feel any worse. The patient stated, "No, I just don't feel great yet, I lost 5 pounds truthfully" and with treatment, the patient stated, "No, just drink water." The patient thought maybe other people were having this, were other people calling that they got that sick and the patient was not obese or anything. The patient know they make it like if they were overweight, terribly overweight, have a worse reaction, the patient was a little overweight but hardly any. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 70 | 2021-03-25 | joint pain, joint swelling, muscle pain |
70 y/o female of Asian descent developed a mild, pruritic, hive-like rash on her left arm and leg ab...
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70 y/o female of Asian descent developed a mild, pruritic, hive-like rash on her left arm and leg about 2 days (21 Jan 2021) after receipt of her 2nd BioNTech vaccine (injected in her left arm; no other vaccines given on that day). Patient did not self-treat. Rash continued on 26 Jan when patient was evaluated in Medical Center ER described as "3 small wheals located on left upper and lower extremity with excoriations"; she was treated with Benadryl 25 mg orally and the itching decreased and the rash significantly diminished. No other signs or symptoms concerning for allergic reaction. Patient also reports onset of muscle aches, starting within 48 hours of vaccine receipt; also reports onset of fatigue, headache, and feeling hot. The headache and feeling hot resolved within 72 hours, but fatigue and muscle aches continued. Reports muscles hurt in her arms legs, and chest. Around 22 Jan, patient began having diffuse joint pain in her extremities. The pain became significantly worse on Sun, 24 Jan. Patient self-treated with Ibuprofen with some relief. By 26 Jan, when patient sought evaluation at ER, she described the joint pain as "unbearable" and rated pain intensity as 9/10. In the ER, patient was afebrile and her exam noted: bilateral hand and wrist swelling (left>right), but no redness or warmth at joints; full ROM, but pain increased with movements. Diagnosed as reactive arthritis and prescribed Tiger Balm and Lidocaine patches, with continued Ibuprofen recommended. At follow-up appointment with patient's PCM on 29 Jan, she reported continued muscle and joint pains. She reported some relief with topical analgesics and Ibuprofen, but Ibuprofen upset her stomach, so was changed to Celecoxib 200 mg twice daily as needed. Topicals and Benadryl were renewed. (Benadryl helped rash, but patient ran out and had recurrence of pruritic rash.) Muscle pain continued in her extremities. Reported fair control of muscle pain with topical analgesics and Celecoxib. Reported having "muscle spasms" in her hands. Patient reported increased sensitivity painful sensation when she touched something cold. Reported using a pot holder to hold a cold can of soda to reduce pain. Joint pain primarily in hands, wrists, shoulders, feet, ankles, and knees. Reported swelling of hands and wrists resolved after about 2 weeks. She also had swelling of her left foot, which resolved. Reported some relief of joint pain with topical analgesics and Celecoxib, but joint pain interfering with sleep. Patient's fatigue continued. Spouse describes as decreased stamina. An example: they used to go out to do errands over a 2-hour period and it would not impact patient's energy level; now, after 2 hours of minimal-to-moderate activity, patient is exhausted. Follow-up with PCM on 8 and 18 Mar 2021 rash resolved, but generalized muscle aches and joint pains continue. No localized joint swelling. Full ROM. Labs ordered (see below) patient's Rheumatoid Factor was elevated; she is pending a Rheumatology evaluation (appointment on 17 April). No history of recent trauma or injury. No previous history of similar joint pain. No history of arthritis or Rheumatic disease. Not previously diagnosed with COVID and never tested positive for COVID; was quarantined in 2020 after returning from being on a cruise ship. After 1st COVID vaccine in Dec, she experienced a headache and local redness and tenderness at vaccination site, lasting less than 3 days.
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| 70 | 2021-03-25 | joint pain, muscle pain, neck pain |
Pt received Pfizer COVID vaccine in left arm at 0828 at our high-risk anaphylaxis clinic. After rece...
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Pt received Pfizer COVID vaccine in left arm at 0828 at our high-risk anaphylaxis clinic. After receiving the shot she then proceeded to our monitoring area for 30 minutes. At 0836 pt c/o of mild pain in her left deltoid. RN observed the injection area to be slightly red. Pt no c/o of itchiness or SOB. RN provided the pt with an ice pack. VS 162/110 and pulse ox of 97-99%. At 0855 left arm redness notably decreased. At 0905 pt c/o of feeling SOB. O2 sat of 99% with HR of 114. Pt taken into exam area in back of clinic and put on a stretcher. Now c/o of left shoulder and neck pain. Area tender to touch. Pt placed in 2 liters nasal O2. Rapid response was called at 0915. Team arrived, evaluated pt, and then transported pt to ER for further eval and tx.
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| 70 | 2021-03-25 | limb discomfort, musculoskeletal stiffness |
About 5 hours after the second dose I could not stay awake. I had horrible sweats all night. The fol...
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About 5 hours after the second dose I could not stay awake. I had horrible sweats all night. The following morning my joints were stiff, and I hurt all over. I could not straighten my legs, and my fingers were curled. I could not straighten them. I had 102.2 fever, sore throat, headache, runny nose. Slept most of day 1. Day 2 I had sweats, fatigue, loss of appetite, but thought I was getting better. I was able to straighten my legs and fingers. Day 3 I still had sweats, runny nose, sore throat, headache. Ok by day 4. I did not see my dr.
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| 70 | 2021-03-25 | muscle pain, joint pain | Muscle and joint aches |
| 70 | 2021-03-27 | joint pain, muscle pain |
Temperature high=104 decreasing each hour over 8 hours Extreme coldness for an hour subsiding over ...
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Temperature high=104 decreasing each hour over 8 hours Extreme coldness for an hour subsiding over 8 hours Muscle & joint ache Headache...at times like migraine with light sensitivity VERY TIRED Loss of appetite Disorientation Off balance
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| 70 | 2021-03-29 | joint pain |
lost part of mobility in the small finger of the right hand, can't lift it all the way above; wrist ...
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lost part of mobility in the small finger of the right hand, can't lift it all the way above; wrist pain and it locked; little bumps on the back of her hand; This is a spontaneous report received from a contactable consumer (patient). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: Not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient has had both doses of the covid vaccine. On an unspecified date in Jan2021, she experienced wrist pain and it locked up. There were a little bump on the back of her hand and lost mobility in the little finger of her right hand. The outcome of the events was reported as unknown. Information on the lot batch number has been requested.
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| 70 | 2021-03-29 | muscle pain |
Got the vaccine, her arm didn't hurt to touch, but if she moved it the pain was terrible. The eveni...
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Got the vaccine, her arm didn't hurt to touch, but if she moved it the pain was terrible. The evening of the vaccine she started to feel achy, deep down in her muscles. She was extremely tired, sick to her stomach and headache for 4 days. She had a fever, and actually had chills, her hands were trembling. By Sunday 3/14/21 subsided now, but the headache, achiness, and other symptoms stayed until Monday. She is still achy and tired after almost 3 weeks. She took Advil or Tylenol for the reaction. The fever ranged from 100 - 101 sporadically at different times, which lasted for about a day and a half. Due to this reaction she has decided not to have the 2nd vaccine.
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| 70 | 2021-03-30 | joint pain, muscle pain |
Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; This is a spontaneous r...
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Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Feeling unwell; This is a spontaneous report from a contactable other HCP (patient). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Unknown), via an unspecified route of administration, administered left arm on 19Jan2021 09:30 AM (at the age of 70-years-old) at single dose for covid-19 immunization. The patient was not pregnant. Other vaccine details were First dose Pfizer biotech Covid-19 vaccine EUA with vaccination date 26Jan2021 (Other vaccine same date vaccine date) at left arm. Patient's medical history included 6 months post chemo for lymphoma. No known allergies reported. The patient's concomitant medications were not reported. Patient did not receive other vaccine in four weeks. On 27Jan2021 01:00 AM the patient experienced tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell. No covid prior vaccination. No covid tested post vaccination. No treatment received for events. The outcome of event was recovering. Information about lot/batch number has been requested.
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| 70 | 2021-03-30 | joint swelling |
Wrist and Hand on arm of injection was swollen for 3 days after the injection; Wrist and Hand on arm...
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Wrist and Hand on arm of injection was swollen for 3 days after the injection; Wrist and Hand on arm of injection was swollen for 3 days after the injection; This is a spontaneous report from a contactable consumer (reported for herself). A 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265 and expiry date was not provided), via an unspecified route of administration, in arm right, on 31Jan2021 08:00, as a single dose for Covid-19 immunization, at hospital. Patient's medical history included Parkinsons and allergies to penicillin. Concomitant medications included carbidopa, levodopa and diltiazem (within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 01Feb2021 03:00 AM, the patient had wrist and Hand on arm of injection was swollen for 3 days after the injection Patient was received no treatment for the adverse events. Outcome the event was recovered on an unknown date in Feb2021.
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| 70 | 2021-03-30 | muscular weakness |
sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sud...
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sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; Fever; headache; flu like aches; tiredness; This is a spontaneous report from a contactable female consumer (patient) A 70-year-old female patient (non -pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EJ1686; Expiration Date: unknown), via unspecified route of administration, anatomical location: - Left arm On 20Jan2021 at single dose for COVID-19 immunisation. The patient Medical history included Slight asthma, fibromyalgia. concomitant medications include Shingrix on 04Jan2021. Patient experienced Fever, headache, flu like aches, tiredness Not concerned about this, had same reaction to shingles vaccine. But six days later sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs. Had a negative reading for covid three days after vaccine. The intensity of the feeling began to decrease after 48 hours but the feeling and weakness is still present..patient was not diagnosed with COVID-19 vaccination. The patient was tested for COVID-19 since the vaccination, (covid test type Nasal swab, covid test date-23Jan2021, covid test result-Negative) The outcome of event was not recovered.
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| 70 | 2021-03-31 | joint pain |
Extreme fatigue, low grade fever to 100.6, severe headache, joint pain. Symptoms lasted about 36 hou...
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Extreme fatigue, low grade fever to 100.6, severe headache, joint pain. Symptoms lasted about 36 hours. Headache lasted beyond other symptoms.
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| 70 | 2021-03-31 | back pain |
Fever. Shingles. Urgent Care. Antiviral drug. Pain med. Still have shingles almost a month later. Ba...
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Fever. Shingles. Urgent Care. Antiviral drug. Pain med. Still have shingles almost a month later. Back pain, stomach pain, itch.
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| 70 | 2021-03-31 | muscular weakness |
SEVERE MUSCLE PAIN in arm shoulder weakness numbness on left side where vaccine injected SEVERE MUSC...
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SEVERE MUSCLE PAIN in arm shoulder weakness numbness on left side where vaccine injected SEVERE MUSCLE SPASMS
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| 70 | 2021-03-31 | muscle pain | Headache, muscle aches, fever of 101, chills, nausea, fatigue. |
| 70 | 2021-04-07 | joint pain, neck pain |
Severe Lt upper arm and shoulder and Lt neck pain; Severe Lt upper arm and shoulder and Lt neck pain...
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Severe Lt upper arm and shoulder and Lt neck pain; Severe Lt upper arm and shoulder and Lt neck pain; Severe Lt upper arm and shoulder and Lt neck pain; This is a spontaneous report from a contactable Nurse. A 70-year-old female non-pregnant patient (Nurse) received first dose BNT162B2 (Solution for injection, lot number: EN5318, COVID 19, brand: Pfizer) via an unspecified route of administration in left arm on 01Feb2021 at 12: 30 at single dose for COVID-19 immunisation. Patient medical history included Htn (Hypertension), Depression, Asthma, Ulcer (bleeding ulcers hx), known allergies: Sulfa. Concomitant medications included paroxetine hydrochloride (PAXIL), primidone, gabapentin, lisinopril, trazodone. Patient previously took Wellbutrin and had Known allergies. On 02Feb2021 at 12:30 PM, patient had severe Leftt upper arm and shoulder and Left neck pain since. Not relieved with Voltarin Cream and Tylenol Unable to take NSAIDs due to bleeding ulcers HX. No covid prior vaccination, no covid tested post vaccination. Outcome of events was not recovered.
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| 70 | 2021-04-17 | back pain, joint pain, musculoskeletal chest pain |
Lower chest partial atelectasis or scarring in the lung bases bilateral; Partial lung collapse (both...
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Lower chest partial atelectasis or scarring in the lung bases bilateral; Partial lung collapse (both upper and lower parts collapsed); Lower chest partial atelectasis or scarring in the lung bases bilateral; Beneath this area was a red circle where blood clotted or something; Wheezing; Shortness of breath; Swelling of the face; underneath the arm where the injection site was, a big red circle was noted and it was swollen/under her nose and left elbow were red; underneath the arm where the injection site was, a big red circle was noted and it was swollen; I would get hot and cold; I was sweating; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Pain in her chest, stomach, back and head; Fatigue; Pain in left elbow; goes to bathroom and bowel was not emptying the way it should; rib cage is going on the side of body noticed this thumping; Her lips were red; Throat was red; Been sick and just laying around; Her eyes were red; Cramp in left arm where site of injection; Sharp pains were hitting her in her eye, thigh, chest, head, and the arm; Sharp pains were hitting her in her eye, thigh, chest, head, and the arm; This is a spontaneous report received from contactable consumer (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 15Mar2021 (at the age of 70 years) at a single dose in the left arm for COVID-19 immunization. Medical history included lung issues and allergic asthma. Family history included brothers and sisters who died of lung issues and third sibling sister died many years ago due to allergic asthma. The patient previously took flu vaccine for immunization and experienced severe pain throughout her whole body. On 15Mar2021, patient received the first dose of Pfizer COVID-19 vaccine. Later on, that day when she got home after receiving the vaccine, underneath the arm where the injection site was, a big red circle was noted and it was swollen, beneath this area was a red circle where blood clotted or something, she would get hot and cold and take her clothes off because she was sweating but did not have fever, there was pain in her chest, stomach, back and head, wheezing, shortness of breath, fatigue, swelling of the face, pain in left elbow. She goes to bathroom and bowel was not emptying the way it should. She also noted that her rib cage is going on the side of body noticed this thumping, lips and throat were red. She's been sick and just laying around, her eyes, under her nose and left elbow were red, had cramp in left arm where site of injection, and sharp pains were hitting her in her eye, thigh, chest, head, and the arm. Patient clarified that these symptoms began on 15Mar2021, the same day she received the Pfizer COVID-19 vaccine. On 23Mar2021, patient went to the ER and the findings were lower chest partial atelectasis or scarring in the lung bases bilateral and partial lung collapse (both upper and lower parts collapsed). At the hospital her temperature was 98.9 F on 23Mar2021, but 97.1F - 97.7F is her normal temperature. She went to the Pulmonary doctor also, but was getting a second opinion because she knew it could be life threatening. The pulmonary doctor made light of it saying they were just creases, like creases in pants. Patient said crease was a far cry from partial lung collapse on both bases and the Pulmonary doctor also said that it is in the upper part of the lung also. This scared her and made her think nobody cared. She did not know if she should provide the information because the doctor did not seem to believe that that her symptoms were coming from receiving the Pfizer COVID-19 vaccine. She guessed she should provide the information because Pfizer does research. She wanted to know how long do the side effects last and if she should take the second dose. The outcome of the events underneath the arm where the injection site was, a big red circle was noted and it was swollen/under her nose and left elbow were red, pain in her chest, stomach, back and head, wheezing, shortness of breath, fatigue, swelling of the face, pain in left elbow, goes to bathroom and bowel was not emptying the way it should, rib cage is going on the side of body noticed this thumping, lips were red, throat was red, been sick and just laying around, eyes were red was not recovered; while unknown for the other events. Information on the lot/batch number has been requested.
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| 70 | 2021-04-22 | musculoskeletal stiffness |
Body & joint aches that increasingly got worse in hips & back to the point of stiffness & difficulty...
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Body & joint aches that increasingly got worse in hips & back to the point of stiffness & difficulty walking or bending. Got bad again after 2nd shot
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| 70 | 2021-04-24 | muscle pain |
Extreme Muscle pain in left leg; Can not walk; Blood work report abnormal; This is a spontaneous rep...
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Extreme Muscle pain in left leg; Can not walk; Blood work report abnormal; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 01Apr2021 09:45 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included Stroke 7 years ago. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 on 11Mar2021 10:00 AM in right arm for COVID-19 immunization at 70-years-old (lot number: 9W6205). On 02Apr2021, the patient experienced extreme muscle pain in left leg, can not walk, and blood work report abnormal. The events were assessed as serious (disability). The patient underwent lab tests and procedures which included blood test: abnormal on an unspecified date. Blood work report abnormal. The patient received treatment for the events: Ae treatment: Dr. adjusted Potassium and Diuretic Meds. The outcome of the events was not recovered.
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| 70 | 2021-04-29 | back pain |
My left leg started hurting from my foot all the way up to the top of my thy was swollen painful.. t...
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My left leg started hurting from my foot all the way up to the top of my thy was swollen painful.. the morning of 4/21/21
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| 70 | 2021-05-07 | bone pain |
Fever; Pain in bones; Headache; Nausea; Vomiting; This is a spontaneous report from a contactable co...
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Fever; Pain in bones; Headache; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262), via an unspecified route of administration, administered in arm right on 11Feb2021 09:00 AM (at the age of 70-years-old) at a single dose for covid-19 immunisation. Medical history included HBP (High blood pressure). The patient had no known allergies. The patient had unspecified other concomitant medications in two weeks. The patient previously took first dose of BNT162B2 (lot number: EL1284) via an unspecified route of administration on 29Jan2021 at 09:00 AM (at the age of 70-years-old) in left arm at a single dose for covid-19 immunisation. The patient stated that she experienced fever, pain in bones headache, nausea and vomiting on 11Feb2021 09:00 PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The outcome of the events was recovering.
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| 70 | 2021-05-10 | joint pain |
fatigued; hypersensitivity to light, sound and smells; was unable to eat; feel off with stomach; som...
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fatigued; hypersensitivity to light, sound and smells; was unable to eat; feel off with stomach; some joint pain; increasing joint pain and muscle aches; headache; Did not sleep; excessive pain in all joints( pain on the bottom of my feet)/very sore arm; This is a spontaneous report from a contactable consumer. A 70-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EM 9809) via an unspecified route of administration on left arm on 02Feb2021 11:00 AM at single dose for covid-19 immunization. Medical history included Lyme disease (I had lyme disease within the last 3 years) and Allergy. Concomitant medications were not reported. The patient reported, on 09Feb2021 08:30 PM, day after injection she had very sore arm, Wednesday, begun to feel off with stomach and some joint pain. On Thursday, she had increasing joint pain and muscle aches and a base of the skull headache and did not sleep at night. On Friday, it was full blown excessive pain in all joints (pain on the bottom of my feet) and was unable to eat, tried to stay hydrated and slept for one hour at night. On Saturday, hypersensitivity to light, sound and smells, evening all symptoms started to go away and on Sunday, patient was recovering but still fatigued. The patient did not receive any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The outcome of the event fatigue was recovering, and rest of the events was recovered.
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| 70 | 2021-05-12 | muscle pain |
Minor symptoms immediately after vaccinations, including vertigo at first vaccine and brown out on s...
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Minor symptoms immediately after vaccinations, including vertigo at first vaccine and brown out on second. Pain developed over a few hours, including a bad headache after first vaccine. In four days this moved to fairly severe whole body muscular and nerve pain. Had second vaccination 4/17/2021, lot number ER8731. Pain still persisting almost a month later. Myalgia?
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| 70 | 2021-05-17 | rheumatoid arthritis |
Swallowing difficult; Heartburn; Headache; Rheumatoid arthritis flare up; This is a solicited report...
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Swallowing difficult; Heartburn; Headache; Rheumatoid arthritis flare up; This is a solicited report based on the information received by Pfizer, (Mfr. Control No.: 21K-163-3863221-00). Solicited report by a consumer of a 70 year old female with events of non-serious heartburn, headaches since had covid-19 vaccine, rheumatoid arthritis flare ups on on HANDS/FEET and difficult swallowing with Rinvoq (upadacitinib). In 2021, the patient experienced rheumatoid arthritis flare ups on on hands/feet. In Feb2021, the patient experienced heartburn, headaches since had COVID-19 vaccine and difficult swallowing. COVID-19 vaccine was also considered suspect. Patient had a flare up on her hands and feet from time to time. In 2021, she had last one after moving furniture. She stated that Rinvoq helped her a lot with her rheumatoid arthritis. In Feb2021, she had been having headaches since she had her vaccine. They really put her down when she gets them. She had been having heartburn also experienced difficulty of swallowing and she was not sure if it was Rinvoq or Chili that was the cause. Her headache and heartburn was on and off. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 28Jan2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number EL9261. On 16Feb2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer, lot number EM9810. The patient was treated with TYLENOL. Causality for RINVOQ (UPADACITINIB) The reporter's causality for the event(s) of heartburn, headaches since had covid-19 vaccine, Rheumatoid arthritis flare ups on on hands/feet and difficult swallowing with RINVOQ(UPADACITINIB) was a reasonable possibility. Change History On 26Apr2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, treatment drug information and narrative description. The event of "Difficult Swallowing" was added. The event of "Headaches" was amended to "Headaches Since Had Covid-19 Vaccine". No follow-up attempts are possible. No further information is expected.
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| 70 | 2021-05-18 | bone pain, weight decreased, joint pain |
pain with bowel movements; lack of appetite; lost 25 pounds; white blood cells being elevated; pain ...
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pain with bowel movements; lack of appetite; lost 25 pounds; white blood cells being elevated; pain in hip and knees; platelets were a little high; low iron reserves; wants to go to sleep; Bone pain; Chills; Low grade fever; Migraine; headaches; lightly sore arm/pain in her legs; slept extra; lightly sore arm/pain in her legs; This is a spontaneous report from a contactable Nurse (patient). A 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided),via an unspecified route of administration, administered in Arm Left on 24Mar2021 09:15 (at age of 70 years old) as single dose for COVID-19 immunization. Medical History included: IBS Diagnosed over 20 years before, Arthritis From 1992, Asthma From 1980, Diabetes Diagnosed in 1995 or 1999, something like that, allergy to latex. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 03Mar2021 (at 70 years old) at single dose for COVID-19 immunization; The patient had a Flu vaccine and the pharmacist put the needle through the Band-Aid to give it her. The caller then developed a red spot at the injection. She thinks it was because there was latex in the bandage and she is allergic to latex. The patient underwent lab tests and procedures which included body temperature: 100 on unknown date, low grade fever on 04Apr2021, strep throat test: negative on 01Apr2021, Platelet count: a little bit high on 26Apr2021, COVID-19 virus test: negative on 04Apr2021, negative on 07Apr2021, negative on 24Apr2021, White blood cells: being elevated on unknown date, 13.7 on 24Apr2021, weight on unknown date: lost 25 pounds. Patient had Migraine From 03Apr2021, Reporter seriousness for Migraine was Disabling. Low grade fever from 04Apr2021, Reporter seriousness for Low grade fever was Medically significant, Disabling, Bone pain from 05Apr2021, Reporter seriousness for Bone pain was Disabling, pain with bowel movements From Unknown, seriousness for pain with bowel movements was Disabling, Chills From 04Apr2021, Reporter seriousness for Chills was Disabling, lack of appetite From Unknown, Reporter seriousness for lack of appetite was Medically significant, lightly sore arm from 25Mar2021, Reporter seriousness for lightly sore arm was Not serious, wants to go to sleep From: 05Apr2021, Reporter seriousness for wants to go to sleep was Unspecified. The caller is calling to report her side effects on the Pfizer COVID vaccine, the second dose. The caller received her second dose of the Pfizer COVID vaccine on 24Mar2021 and she had a lightly sore arm with a dull ache and pain the first day and that next day, it responded well to Tylenol. 9 days later (03Apr2021), the caller had a migraine with aura for 2 days and she hasn't had a migraine in 20 years. The highest it got was 99.9 axillary. Caller clarified that she had chills and bone pain- on unknown date pain in her legs, hip and knees. The caller was burning up but also freezing at the same time. All of this lasted for about 4 days and then went away. 9 days later, all of this started again so she went to see the doctor on Saturday, 24Apr2021. The caller was told to come back on Monday, 26Apr2021, and she had blood work done: Her platelets were a little high and they said it was low iron reserves. The caller insisted that the doctor start her on an antibiotic so on 30Apr2021 they started her on cefdinir 300mg one twice a day for 10 days, she is still taking this. The caller started feeling a lot better but then her symptoms started again- the aches, fever, chills, and deep bone pain in her femurs. All of this felt like when the caller had walking pneumonia once, the bone pain. The caller's bone pain is in her knees, back, and lower pelvis in the groin area. This is still going on. The caller has lost 25 pounds because of her lack of appetite (both on unknown date, medically significant). The caller mentions that she usually runs a subnormal temperature so her low grade fevers are scaring her. The caller wanted to make sure these symptoms weren't a reaction to the vaccine. Something is going on with the caller, with her white blood cells being elevated on unknown date. The patient slept extra on 25Mar2021. The migraine went away, but she has had headaches (03Apr2021) every now and then with these aches and pains. This is debilitating and really depressing. The bone pain is deep and severe and her bones hurt, its really effecting the quality of her life. Right now she is having pain in the hips and groin area and the bone area, but she is not having fever right now. The doctor on call said to take Tylenol and ibuprofen around the clock and drink lots of water but she gets a low grade fever about once a day. The caller has been taking the Equate brand Tylenol- expiration date Sep2022, lot: BLV2169 or 8LV2169, she is not sure, unknown NDC. The caller has been taking the store brand Ibuprofen 200 mg she takes 2-3 of those if she needs them- lot P12201, expiration date Sep2022, unknown NDC. The caller had to stop her blood thinner to take the ibuprofen. The caller has IBS which has been much worse since all of her other symptoms started happening. The caller would have severe pain with bowel movements but the Bentyl has helped that a lot. The doctor on call said to take Tylenol and ibuprofen around the clock and drink lots of water but she gets a low grade fever about once a day. The caller has been taking the Equate brand Tylenol- expiration date Sep2022, lot BLV2169 or 8LV2169. The caller has been taking the store brand Ibuprofen 200 mg she takes 2-3 of those if she needs them- lot P12201, expiration date Sep2022, unknown NDC. The caller insisted that the doctor start her on an antibiotic so on 30Apr2021 they started her on cefdinir 300mg one twice a day for 10 days, she is still taking this. The caller started feeling a lot better but then her symptoms started again- the aches, fever, chills, and deep bone pain in her femurs. All of this felt like when the caller had walking pneumonia once, the bone pain. NDC, lot, and expiry not provided for Cefdinir. The caller has IBS which has been much worse since all of her other symptoms started happening. The caller would have severe pain with bowel movements but the Bentyl has helped that a lot. Caller stated she already spoke to the safety department but did not have any reference number to provide. Caller Stated she received the second Pfizer COVID vaccine and wanted to know if similar side effect were reported of what she is experiencing and the length of time. She received her second dose on 24Mar2021 and from 03Apr2021 she is having Migraine headaches, On 04Apr2021 she had fever and chills. they resolved and stated again 9 days later. She tested negative for COVID. Has really bad "bone pain" loosing weight, no appetite, pain is still there. her white cells count is 13.7 (24Apr2021), she is getting antibiotics. her side effects are intermittent. The caller's temperature was 100 and her son had strep throat so she went to the urgent care and got tested for strep. The Nurse Practitioner there said she had typical side effects from the vaccine. Physician office visit for all events. Treatment received for event Migraine, Low grade fever, Bone pain, pain with bowel movements, Pain in extremity, headaches, Platelet count increased, Iron deficiency. The outcome of the event Migraine was recovered on 04Apr2021, Bone pain was recovered in 2021, lightly sore arm/pain in her legs recovered on 26Mar2021, pain in hip and knees was recovered on unknown date, lack of appetite, lost 25 pounds was recovering, for Low grade fever, wants to go to sleep, slept extra, Chills, pain with bowel movements was not recovered, for other events was unknown. Event relatedness: Pfizer covid vaccine with lightly sore arm was Related, with pain with bowel movements was Unknown, with lack of appetite was Related. information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 71 | 2021-01-12 | muscular weakness |
Approximately 22 hours after I received the first vaccine my left arm from the elbow down to my hand...
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Approximately 22 hours after I received the first vaccine my left arm from the elbow down to my hand went numb. No tingling just no feeling. Could not hold anything and no strength in that arm and hand.
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| 71 | 2021-01-14 | back pain |
Pfizer-BioNTech COVID 19 Vaccine EUA Throbbing pain in my right back area inside - not on the skin ...
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Pfizer-BioNTech COVID 19 Vaccine EUA Throbbing pain in my right back area inside - not on the skin - possibly near the kidney
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| 71 | 2021-01-16 | muscle pain, joint pain |
injection site redness and soreness, severe migraine headache, severe myalgia (even the tendons in m...
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injection site redness and soreness, severe migraine headache, severe myalgia (even the tendons in my hands and feet hurt), arthralgia, chills, rigors, swollen lymph nodes lasted two and a half days, mostly spent in bed
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| 71 | 2021-01-18 | armpit pain |
Left upper arm pain and redness Rash left upper arm to left mid forearm Swelling and tenderness lef...
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Left upper arm pain and redness Rash left upper arm to left mid forearm Swelling and tenderness left axilla Swelling and tenderness left breast
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| 71 | 2021-01-19 | back pain | NECK AND BACK ACHE IN THE MORNING (1/19). FEVER 98.9. TOOK TYLENOL |
| 71 | 2021-01-20 | back pain, joint pain |
Arm, shoulder and lower back pain, bodyaches, diarrhea, nausea, vomiting, fatigue, weakness on day a...
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Arm, shoulder and lower back pain, bodyaches, diarrhea, nausea, vomiting, fatigue, weakness on day after vaccine; fatigue and weakness on day 2 after.
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| 71 | 2021-01-21 | back pain |
Very tired after vaccination. Went to sleep about 8 PM Sat 1/16 and slept most of the next 4 days. ...
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Very tired after vaccination. Went to sleep about 8 PM Sat 1/16 and slept most of the next 4 days. Stomach was queasy. Unable to drink coffee. Tried to push fluids and tried to just eat bland foods. Would wake up sporadically but was unable to awaken enough to watch an entire TV show. Pretty lethargic and brain fog. Was able to wake up a little more on Wed 1/20 but still had the queasy stomach. Started getting Headache and Eye pain and severe upper leg and lower back burning & cramping, I tried taking tylenol which helped a little. By Thursday the pain was worse. I was still tired only walking helped the pain. It got worse if I sat down and extremely bad if I laid down to try to sleep. It's Friday morning & I am planning to go to med check this AM. Symptoms still ongoing
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| 71 | 2021-01-26 | back pain, joint pain |
Periodic Tingling sensation like electric impulses shooting from injection area in a line up arm, ac...
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Periodic Tingling sensation like electric impulses shooting from injection area in a line up arm, across shoulder and up neck about ear level; Low back/ hip pain I haven?t had before, especially at night turning over in bed. Self-massage, change position
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| 71 | 2021-01-26 | muscle pain | Mild fever, nausea headache, extreme fatigue, muscle ache, stuffy nose, sore throat, sore arm |
| 71 | 2021-01-27 | joint pain |
tenderness on the left arm where she received the vaccine dose.; severe pain in right shoulder joint...
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tenderness on the left arm where she received the vaccine dose.; severe pain in right shoulder joint and right hip joint/It was so severe she could hardly get out of bed; Headache; This is a spontaneous report from a contactable nurse (patient). A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1686, expiration date unspecified), via an unspecified route of administration on 31Dec2020 11:00 at single dose (left arm) for COVID-19 immunization. Medical history included arm soreness from flu shot 2-3 months ago. There were no concomitant medications. It was reported that she received her 1st dose of the vaccine on her left arm on 31Dec2020 as she works with elderly at nursing home and she was of age. Two days after her shot, on 02Jan2021, she experienced little headache which lasted all day but was gone by the following day. On 12Jan2021, 2 days ago, when she woke up and got of bed with severe pain in right shoulder joint and right hip joint which lasted for maybe 10 minutes. It was so severe she could hardly get out of bed. Currently, she had no joint pain. The right shoulder and right hip pain were so odd she thought, but it has also improved since. It's been 2 weeks and she never had this happen before. This lasted a little while, but thought it was from the cold weather since it's been 2 weeks since having the vaccine. She still has a bit of tenderness on the left arm where she received the vaccine dose on an unspecified date. She mentioned this to her supervisor and was encouraged to call and she wants to know if this could be a side effect. The patient had no vaccines the same day or 4 weeks prior. She had the flu shot before in past and the area would be sore for a few days, but now with this Covid vaccine this arm was still tender. Also, she had gotten the shingles shot the same day as the flu shot but that was about 2-3 months ago, at least 2 months ago. The patient had no additional vaccines administered on same date of the Covid vaccine. The patient had no prior vaccinations within 4 weeks prior to the first administration. Outcome of event headache was recovered on 03Jan2021; severe pain in right shoulder joint and right hip joint/it was so severe she could hardly get out of bed was recovered in Jan2021; and outcome of tenderness on the left arm where she received the vaccine dose was not recovered.
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| 71 | 2021-01-29 | muscle pain |
The day after vaccination, I was extremely tired and had a low-grade fever (99.1 F). My muscles ach...
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The day after vaccination, I was extremely tired and had a low-grade fever (99.1 F). My muscles ached all over. I could not get out of bed until 5:00 pm. After that, I was able to do my chores (laundry and washing dishes). I was fine the following day.
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| 71 | 2021-01-30 | musculoskeletal stiffness |
several unusual symptoms started 6 days after immunization: sudden, painful outbreak of cold sores, ...
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several unusual symptoms started 6 days after immunization: sudden, painful outbreak of cold sores, stiff, not painful joints, tiredness, and (the most unusual) is an elevation of my blood glucose to at and above 180 for about 24 hours (I have used a continuous glucose monitor for the past 7 months and have learned food/body responses and usually drop into the 120 range over night. i have daily graphs for the time represented here). No treatment except caution on food and continued regular medications, outcome. All these symptoms stopped about 48 hours later on Saturday, Jan 30, 2021. I am reporting for information only regarding this new vaccine. I intend to take my second, booster dose in the regular 3 week interval. Did not consult physician nor clinic.
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| 71 | 2021-01-31 | limb discomfort, armpit pain, musculoskeletal discomfort |
two days after injection had significant discomfort bilateral arms, bilateral axilla and back this p...
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two days after injection had significant discomfort bilateral arms, bilateral axilla and back this persisteded for 10 days following the injuection
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| 71 | 2021-02-02 | joint pain, muscle pain |
The next day I woke up with severe muscular pain and joint pain, fever of 100 degrees, dizziness, he...
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The next day I woke up with severe muscular pain and joint pain, fever of 100 degrees, dizziness, headache, appetite loss. Took 2 Tylenol and it improved. 6 hours later I took another 2 Tylenol because the headache came back strong. I sleep a couple of times during the day, and also slept well during the night. The next day felt a little bit better but still in bed, but was able to eat better. The next day went to the Dr. and he prescribed me Meloxicam and 6 hour later Tylenol, after that is getting better.
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| 71 | 2021-02-03 | joint pain, muscle pain |
In the middle of the night about 2AM in the morning I started feeling nauseated and vomited and then...
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In the middle of the night about 2AM in the morning I started feeling nauseated and vomited and then noticed I had chills. Probably after 8AM I took my temp and I had a fever (102F) for about 10 hours. Started aching all over, joint and muscle aches, I also had headache (took Motrin and headache went away), no pain at the injection site. Almost like I had flu symptoms. I felt miserable all day but next day when I woke up I was fine. Went to work as normal the next day. I forgot to state I had COVID in March 2020 and the symptoms I had felt very much like it.
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| 71 | 2021-02-03 | limb discomfort |
2/2/21 Slight arm discomfort - went away after an hour. Face became red, blotchy and itchy in afte...
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2/2/21 Slight arm discomfort - went away after an hour. Face became red, blotchy and itchy in afternoon. Took benedry tablets and allegra cream. 2/3/21 woke up with puffy face. Still had redness and itchy. Contacted nurse association suggested fill out this form and contact my doctor. my doctor said go to urgent care clinic. I decided to call my dermatologist who I will meet with today. Note: Not sure if this is reaction to vaccination - I have never had an adverse reaction to taking any type of vaccine.
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| 71 | 2021-02-03 | musculoskeletal stiffness, joint pain, muscle pain |
Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaki...
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Where the injection was given is real sore; Chills; Muscle pain; Joint pain; Fever; Nauseated; shaking really hard; feeling unwell; still cold; Just like when one catches the flu, all the symptoms came at one time; It was so stiff one time; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EK01231), via intramuscular route on the left arm on 19Jan2021 12:11 as a single dose for COVID-19 immunization. Medical history included stomach issues, two stents, pacemaker, asthma that turned into bronchitis. Historical vaccine data included the pneumococcal 13-valent conjugate vaccine (PREVNAR 13) first dose in "September" and the second Pneumonia shot on 11Jan2021, second dose, on the right arm within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing prasugrel for blood thinner. On 20Jan2021 03:00, the patient experienced really heavy chills, she was shaking really hard, she had muscle pain like the flu, joint pain, fever that started at 100.6 degrees Fahrenheit and worsened to 101.6 degrees Fahrenheit, nauseated, feeling unwell. The caller clarifies that all of the symptoms came on at once, around 3am. Just like when one catches the flu, all the symptoms came at one time. The patient reported that it felt like she had the virus (not specified) all over again. The chills had calmed down, but she was still cold. Where the injection was given it was real sore. She had been doing arm circles and such to keep her muscles loosened up. It was so stiff at one time last night (20Jan2021) that she thought, she could not move it. The clinical outcome of events chills was recovering; muscle pain, fever, nauseated, still cold was not recovered; joint pain, shaking really hard, feeling unwell, vaccination site pain, stiff, flu like symptoms was unknown.
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| 71 | 2021-02-03 | muscle pain, joint pain |
My first dose I woke up in the morning really tired, chills, muscle aches and a headache, that laste...
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My first dose I woke up in the morning really tired, chills, muscle aches and a headache, that lasted all day and next day was a fine. No medication needed. I also noticed knee pain in both knees mainly when I am moving around. I was not having that problem before the vaccine.
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| 71 | 2021-02-03 | neck pain |
Fever from 99 to 101.2 the 2nd 24 hrs. Headache neck ache severe fatigue and increased coughing and ...
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Fever from 99 to 101.2 the 2nd 24 hrs. Headache neck ache severe fatigue and increased coughing and congestion
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| 71 | 2021-02-04 | joint pain, muscle pain |
Chills, muscle and joint pain, and fatigue from 11:00am. Till 5:00pm the day following the injectio...
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Chills, muscle and joint pain, and fatigue from 11:00am. Till 5:00pm the day following the injection
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| 71 | 2021-02-04 | muscle pain, joint pain |
cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea;...
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cough; injection site pain; headache; muscle pains; joint pain; fever, but not a high fever; nausea; feeling freezing cold; chills; ache; cold; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), via an unspecified route of administration at left arm on 19Jan2021 08:15 at a single dose for COVID-19 immunization. She was sick (COVID symptoms) all Dec2020 when she was with her sister who had COVID-19. She does not know for sure that she had COVID 19 because she was never tested. She recovered from that illness about two weeks before getting the Pfizer COVID 19 vaccine first dose. The cough was all gone before she had the Pfizer COVID 19 vaccine. No prior vaccinations (within 4 weeks). There were no concomitant medications. The patient had the vaccine on 19Jan2021, two days ago and had not had a problem. She left there and went to the gym for 1 hour afterwards. Then yesterday morning she woke up and has been sick ever since with a cough and chills. She never tested positive for COVID but she was with her sister who had it during Dec2020. She had a cough similar to the one she had in Dec2020 when she was quarantined for COVID symptoms. She was not expecting anything, but it says you can have side effects if you have had COVID-19 so she was calling in about that. On 20Jan2021 she woke up at 02:00 in the morning with a cough; injection site pain which was not sore before; headache; muscle pains, chills; joint pain; fever, but not a high fever; feeling freezing cold; and nausea. She reported 'cold, chills, fever, ache'. She felt a little bit better today on 21Jan2021. She was scheduled to receive the second dose on 15Feb2021 at 08:15. The patient would like to know whether her history of COVID symptoms from Dec2020 may have aggravated her post-vaccination symptoms. The patient would like to know whether there have been other reports of similar post-vaccination as hers. The outcome of the events cough, injection site pain, headache, fever and feeling freezing cold was recovering; event muscle pain, joint pain and nausea was not recovered; event chills was recovered on 21Jan2021; and unknown for the other events.
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| 71 | 2021-02-04 | muscle pain, joint pain |
Headache, tiredness, muscle pain, chills, joint pain, soreness at injection site and nausea caused ...
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Headache, tiredness, muscle pain, chills, joint pain, soreness at injection site and nausea caused from the really bad headache.
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| 71 | 2021-02-05 | joint pain |
Within 6 minutes of infection had lightheadedness & difficulty breathing. This was followed by red ...
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Within 6 minutes of infection had lightheadedness & difficulty breathing. This was followed by red flushing to the skin on the face and left neck, shoulder & hip pain. BP initially was 182/98 which is elevated for me. Felt disoriented & very unwell. Over the next few days, low BP was noted @90/62, pulse 58. This occurred intermittently.
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| 71 | 2021-02-05 | muscle pain, joint pain |
Muscle aches and sore left arm in the evening, trouble sleeping that night. Next morning, light head...
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Muscle aches and sore left arm in the evening, trouble sleeping that night. Next morning, light headed, extremely tired, sore arm, joint aches Spent the morning in bed and the afternoon on the couch. Temp 99.8 Took tylenol several times during the day and that night. By the following morning most of the symptoms had disappeared with a moderately sore left arm still present.
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| 71 | 2021-02-06 | joint pain | Mild site pain, headache, joint pain and fever |
| 71 | 2021-02-07 | joint pain, muscle pain |
The morning following the vaccine, she had a fever, chills, felt really sick. Also had a headache, ...
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The morning following the vaccine, she had a fever, chills, felt really sick. Also had a headache, a lot of muscle and joint pain. She was nauseous, no appetite, and abdominal pain. Very tired as well. She did not take anything for it, just slept and by the morning of 2/6/21 was still tired, but not sick anymore and able to eat some, was not able to prior to this.
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| 71 | 2021-02-07 | joint pain, neck pain | 2 |
| 71 | 2021-02-07 | joint pain |
10:45 a.m. Fatigue 12::00 pm headache 2:00 pm achy joints 5:00 p.m. took one Tylenol Rapid Release 5...
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10:45 a.m. Fatigue 12::00 pm headache 2:00 pm achy joints 5:00 p.m. took one Tylenol Rapid Release 500mg 9:00 p.m. low grade fever 99.8 10:00 p.m. took two Tylenol Rapid Release 500mg 3:00 a.m. awoke, joint pain all joints, low grade fever and headache took two Tylenol Rapid Release 500mg 9:00 a.m. awoke, fever gone temperature normal, headache, achy joints continued throughout the day 7:00 p.m. headache subsided 10:00 p.m. less fatigue but still achy joints Took two Tylenol Rapid Release 500mg 1/18/2021 9:00 a.m. awoke feeling normal
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| 71 | 2021-02-07 | muscle pain, joint pain |
Swelling at site of shot, tiredness, headache, muscle pain, chills, joint pain, fever, swollen lym...
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Swelling at site of shot, tiredness, headache, muscle pain, chills, joint pain, fever, swollen lymph nodes. Gout flare up. Began 29 hours after injection with chills and fatigue followed by fever, etc. Lasted until next morning (47 hours after shot) with just a remaining headache.
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| 71 | 2021-02-07 | neck pain |
Symptoms: Pain in back of neck, right side facial paralysis, swelling, right eye not closing, un ...
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Symptoms: Pain in back of neck, right side facial paralysis, swelling, right eye not closing, un even smile. Went to ER. Diagnosis was Bell's Palsy. Treatment included a course of prednisone and Valtrex and lubricating eye drops as needed.
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| 71 | 2021-02-08 | musculoskeletal stiffness |
Hands shaking and looked like she has Parkinson's; Blood pressure was 183 over something, which is h...
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Hands shaking and looked like she has Parkinson's; Blood pressure was 183 over something, which is high for her; Felt heart palpitations and pressure in her chest; Felt heart palpitations and pressure in her chest; Facial flushing, redness; Facial flushing, redness; Lips swollen and numb; Lips swollen and numb; Left arm stiffness; This is a spontaneous report from a contactable consumer reported for self. This 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 12:30 on Arm left at single dose (lot number: EL8982) for Protection from COVID. Medical history included diabetes, slightly elevated blood pressure, taking drops under her tongue for her 21 environmental allergies, clarified product as sublingual immunotherapy, had a reaction to some kind of steroid shot recently. Had bad hives from it. Believes the steroid shot started with "met." And allergy to antibiotic. Concomitant drug included Sublingual immunotherapy, metformin at 500 mg and cetirizine hydrochloride (ZYRTEC). Past drug history included had Drug hypersensitivity to Neurontin, Detrol, Sulfur, and Neuropherntin. The patient experienced facial flushing, redness, and her lips felt like she had a Novocain shot on 22Jan2021. Her lips are still kind of numb. Can't feel her lips when she bites down on them. Believes reaction was fairly immediate. Sitting there for 15-20 min. Could feel a little facial flushing. Went home because (name withheld) is 45 minutes away from her house. By the time she got home was very flushed. Lips were getting more swollen and numb on 22Jan2021. Had an Epinephrine injection UPS Auto injector 0.3 mg, NDC: 49502 10201,Lot: 9FM783, Exp: Jun2021, Dose: injected one time in the middle of her right thigh and used it. Went to the ER. Had blood work and an EKG done. Was kept for five hours in ER. Had a chest x-ray. Blood pressure was 183 over something, which is high for her on 22Jan2021 that is controlled with medication. Experienced Hands shaking and looked like she has Parkinson's on 22Jan2021. Only lasted for a short time. Put on Prednisone for five days and told to see primary physician. Can't get into primary physician until Wednesday. Felt heart palpitations and pressure in her chest. Can't separate if it was the COVID-19 Vaccine or her nerves. She experienced Left arm stiffness on 22Jan2021. AEs require a visit to ER, was discharged from ER. Lab data on 22Jan2021 included Two sets of blood work separated by 3-4 hours: Unknown Results, Chest X-ray: Unknown Results, EKG: normal; on unknown date had a colonoscopy the day before the COVID-19 Vaccine: Unknown Results; Treatments were received for the events. Outcome of the events was unknown.
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| 71 | 2021-02-08 | muscle pain |
Had bad headaches, muscle pain, SOB, feels hot inside the body and then it goes away, had chest and ...
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Had bad headaches, muscle pain, SOB, feels hot inside the body and then it goes away, had chest and arm pain
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| 71 | 2021-02-09 | joint pain, muscle pain |
Very deep muscle pain, that kind of comes and goes; Joint pain, it's like just deep and very achy as...
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Very deep muscle pain, that kind of comes and goes; Joint pain, it's like just deep and very achy as opposed to like any kind of shooting pain; Joint pain, it's like just deep and very achy as opposed to like any kind of shooting pain; This is a spontaneous report from a contactable consumer, reporting for herself. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 (at the age of 71 years old) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications were not reported, but she was taking other medications. On 23Jan2021, the patient experienced very deep muscle pain, that kind of comes and goes. On an unspecified date in Jan2021, the patient experienced joint pain, it's like just deep and very achy as opposed to like any kind of shooting pain. The patient received treatment for the events, which included ice pack, Tiger Balm, and ibuprofen 600mg . The clinical outcome of muscle pain was not recovered, and for joint pain and ache was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 71 | 2021-02-09 | joint pain, neck pain |
Day after pain intense and unable to lift right arm. Later 2nd day pain extended up to right shoulde...
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Day after pain intense and unable to lift right arm. Later 2nd day pain extended up to right shoulder still unable to lift arm. (Had been attempting movement with help of left arm) second night sleep impossible because of pain and sensitivity to any pressure to that arm. Pain moved into back of neck on right side. 3rd day felt like I had a severe flu. Felt bad all over. Again no sleep and pain now includes down to elbow. All of these symptoms have remained fairly consistent up to today(day 6) including little sleep. Taking Tylenol with no affect. Have ERG and have been told not to take Ibupropen.
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| 71 | 2021-02-09 | muscle pain |
Muscle pains in legs like unto a lactic build up; Nose burning when inhaling, especially in cold air...
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Muscle pains in legs like unto a lactic build up; Nose burning when inhaling, especially in cold air; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 06Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history was None. Concomitant medication included escitalopram, meloxicam (MOBIC), acetylsalicylic acid (ASPIRIN (E.C.) and calcium carbonate, colecalciferol (CALCIUM D3). The patient was not pregnant. She had no other vaccines in four weeks prior covid vaccine. The patient had no covid prior vaccination. She had not tested for covid post vaccination. The patient had no known allergies. The patient experienced nose burning when inhaling, especially in cold air. She had muscle pains in legs like unto a lactic build up. These were still happening after 18 days from injection which are worse at night. The events started on 06Jan2021 at 10: 45 AM with outcome of not recovered. No treatment received for the events. Information about Batch/Lot number has been requested.
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| 71 | 2021-02-10 | musculoskeletal discomfort |
After getting vaccine and driving home I had tingling in right leg from calf to toes, lasted about 2...
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After getting vaccine and driving home I had tingling in right leg from calf to toes, lasted about 20 minutes. From 7:00 thru 9:00pm had tightness in middle of chest and upper back discomfort. Next morning no reactions other than sore injection site.
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| 71 | 2021-02-10 | muscle pain |
On second day experienced muscle aches over body and extreme fatigue. Slept most of the day and was ...
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On second day experienced muscle aches over body and extreme fatigue. Slept most of the day and was fine the next day. Also muscle soreness in arm for approximately three days.
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| 71 | 2021-02-11 | joint pain |
After vaccination, the next day sore arm, by Friday I didn?t fee good and on Saturday I was hurting ...
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After vaccination, the next day sore arm, by Friday I didn?t fee good and on Saturday I was hurting down my arm into my joints from top of neck all the way down arm. I had breast surgery 1 ½ ago and don?t know if its significant. I was diagnosed with Shingles by my physician.
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| 71 | 2021-02-15 | muscle pain |
I have a condition known as Spinal Stenosis. Diagnosed 3years ago. If creates alternating pain in ne...
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I have a condition known as Spinal Stenosis. Diagnosed 3years ago. If creates alternating pain in neck, shoulders and upper arms, mostly on my right side. I had the shot in my left arm. The next morning at 10:00 AM, I started having spasms in my upper right arm that continued for 6 hours. I have never had anything like this happen before. It was completely debilitating. I sat for hours with heating pad on neck and arm. It was so painful I had tears in my eyes for most of the day. I slept on and off while heat treating it. Then after about 6 hours it stopped. The next day the muscles in that area were sore.
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| 71 | 2021-02-15 | neck pain |
Headache and neck pain sporadic and occurs predominantly in late afternoon/evening. This is continu...
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Headache and neck pain sporadic and occurs predominantly in late afternoon/evening. This is continuing on 2/16/2021.
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| 71 | 2021-02-18 | joint pain, neck pain |
Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; re...
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Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; red flush to skin on the face; left neck & shoulder pain; left neck & shoulder pain/ hip pain; fatigue; Very disoriented; BP 182/98, elevated for me; Felt extremely unwell; This is a spontaneous report from a contactable other HCP reported for self. This 71-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 14:00 on Arm left at single dose (Lot # EK4176) for covid-19 immunisation. Medical history included Codeine experienced upset stomach only, Osteoporosis, nothing else ongoing. No covid prior vaccination. No other medications in two weeks. No other vaccine in four weeks. Within 6 minutes of injection had lightheadedness & difficulty breathing. This was followed by red flush to skin on the face. Within the next hour, left neck & shoulder pain, hip pain and fatigue. Very disoriented and BP 182/98, elevated for the patient, felt extremely unwell all on 28Jan2021. Over the next week, BP low 90/62 Pulse 58 intermittently in Feb2021. Doctor or other healthcare professional office/clinic visit, Prolongation of existing hospitalization. No covid tested post vaccination. No treatments received. Outcome of the events was not recovered.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 (COMIRNATY) to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 71 | 2021-02-18 | joint pain | Extremely cold, migraines, nausea, tightness in chest, face rash, joint pains, extremely tired |
| 71 | 2021-02-18 | joint pain |
Received complaint call 2/19/21 from patient regarding administration site being anterior arm for 1s...
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Received complaint call 2/19/21 from patient regarding administration site being anterior arm for 1st dose of Covid-19 vaccine on 2/16/21. Submitted photos with band-aid placement towards anterior mid-upper arm. Complaints of pain/discomfort to arm (whole arm) also in shoulder area. Discussed that arm discomfort can come with vaccination as an expected outcome. Describes that she did not have pain in arm during injection when administered. Clients concern is regarding administration and if administered in tissues versus muscle if vaccine will still be absorbed by body and be effective. Consulted with "medical professionals" regarding technique and was encouraged to call vaccine administration site.
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| 71 | 2021-02-18 | bone pain, muscle pain |
I received my first Pfizer vaccination on 12/31/2020 at Vaccination Site. following this vaccine, I ...
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I received my first Pfizer vaccination on 12/31/2020 at Vaccination Site. following this vaccine, I had only a brief episode of chills, nausea and cough for several days. My arm was sore. My second shot 21 days later was a different story. I had it in right arm because my left arm was still aching. ( 01/21/2021 ) date of my second vaccination. Since then I have continually had pain "all over my body" My bones and muscles literally ache so badly I cannot sleep. I have called for appointment with my Dr because it isn't going away. I had a cough ( I never cough) until this past week. My concern is the ongoing aching and soreness in different spots on my skin bones and muscles. My shoulders, neck and pelvic region.
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| 71 | 2021-02-18 | rheumatoid arthritis |
Shoulders, ankles, elbows and everything were all hot with flare ups; markers for ESR, and CR were m...
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Shoulders, ankles, elbows and everything were all hot with flare ups; markers for ESR, and CR were more than double what they should be; markers for ESR, and CR were more than double what they should be; 5 days after, I started feeling soreness and it has got progressively worse; 5 days after, I started feeling soreness and it has got progressively worse; This is a spontaneous report from a contactable Nurse, the patient. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL8982), via an unspecified route of administration on 13Jan2021 (at the age of 71-years-old) as a single dose for COVID-19 vaccination and started to receive methotrexate (ACCORD HEALTHCARE, lot number unknown, expiration date 12Nov2021) on an unspecified date (reported as seven years ago) at a dose of 17.5 mg weekly (seven tablets once a week) for Rheumatoid Arthritis. Medical history included rheumatoid arthritis from an unspecified date. Historical vaccinations included "every vaccine known. I've had all my vaccines, flu whatever" (as reported) on unspecified dates. It was unknown if the patient had received any other vaccinationa in the fourteen days prior to this inoculation. Concomitant medications included folic acid (MANUFACTURER UNKNOWN). On 18Jan2021 (reported as about five days after the shot), the patient had just a little soreness and she thought that was one of the side effects that you have that with the vaccine. So, she didn't worry so much about it. But then it got progressively worse. And by the time just before she was supposed to get the second shot, it was really bad. But she thought that she was still going to get that second shot which was planned for "02Feb2021 or 03Feb2021" (also reported as on 02Feb2021) because she didn't want to not get it. She was struggling with the pain before she got the second one. She mentioned that by the time she got her second dose, she was in an RA flare. She continued by saying that she had her blood work done, "on Tuesday morning" because she was due for her RA exam in Mar and it was due, and her markers for ESR, and "CR whatever" were more than double what they should be. Her Rheumatololgist saw her and when she went to the doctor her shoulders, her ankles, her elbows and everything were all hot with flare ups. Treatment included Prednisone 10mg every day which was given, according to the patient, in order to "calm down my joints and everything." The action taken with methotrexate was not reported. The clinical outcomes Rheumatoid Arthritis flare up, pain, condition aggravated, ESR increased and CRP increased were reported as unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Rheumatoid arthritis flare up, ESR increased, and CRP increased cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 71 | 2021-02-19 | joint pain, back pain |
1. Migraine headache for 5 days non stop since 2/15/21. There is no relief with OTC meds. 2. Excru...
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1. Migraine headache for 5 days non stop since 2/15/21. There is no relief with OTC meds. 2. Excruciating stabbing electrical pain on the right side of brain since 2/15/21 3. Joints ache, back hurts started 4 days after injection 2/15/21 4. Feverish, malaise, started 4 days after Pfizer 2 on 2/15/21 5. Pfizer vaccine shot 2 has impacted my life negatively since date of injection 2/15/21. I am not well enough to get out of bed and participate in my daily routine. I need ice on my head for non stop headache and stabbing head pain. Side effects suck.
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| 71 | 2021-02-20 | joint pain, back pain |
Had vaccination at 4:15pm observed for 15 minutes at the clinic by medical personell.. whilst drivin...
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Had vaccination at 4:15pm observed for 15 minutes at the clinic by medical personell.. whilst driving home, felt dizzy and nauseated, pain in my back through to my stomach like Indigestion. After one hour vomited and continued to vomit x 4 over a 12 hour period. also felt like I had indigestion from my back through to my front and aches and pains in my joints, this is my 4th day
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| 71 | 2021-02-20 | neck pain |
left arm sore. Left arm painful to lift up. Pain runs from left arm to neck left tendon. Entire body...
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left arm sore. Left arm painful to lift up. Pain runs from left arm to neck left tendon. Entire body is cold even with two layers of clothing. Especially both feet.
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| 71 | 2021-02-21 | joint pain, muscle pain |
Feb 11, sore arm for one day; Feb 17 started with muscle and joint pain, especially tender right kne...
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Feb 11, sore arm for one day; Feb 17 started with muscle and joint pain, especially tender right knee and overall not feeling well; Feb 18 felt lightheaded and weak with standing through out the day; Feb 19 weakness and lightheaded much worse, had several episodes of vomiting and become too weak to stand; went to ER
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| 71 | 2021-02-21 | muscular weakness |
about 30 to 40 minutes after shot on my way home. my lips, tongue, and throat was swelling. Lasted ...
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about 30 to 40 minutes after shot on my way home. my lips, tongue, and throat was swelling. Lasted until after 5 pm . the next day through the following day i had burning on my tongue and mouth. Strange sensation. Slight weakness in my legs through Monday and then i was fine. On Monday i called my doctor and the doctor suggested that i go for my second shot and let them know of my reaction and let them decide if i should take my second shot.
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| 71 | 2021-02-21 | muscle pain, joint pain |
severe muscle and joint pain; severe muscle and joint pain; fever 100°F; dizziness; severe headache...
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severe muscle and joint pain; severe muscle and joint pain; fever 100°F; dizziness; severe headache; no Appetite; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EI9262), via an unspecified route of administration on 24Jan2021 at 14:00 on the left arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination and had no known allergies. The patient previously received the first dose of BNT162B2 (lot number: EH9899) on 03Jan2021 on the left arm for COVID-19 immunization. It was reported that on 25Jan2021, the next day after the vaccination, the patient woke up with severe muscle and joint pain, fever 100°F, dizziness, severe headache and no appetite. The patient took 2 Tylenol and it got better. Six hours later she took another 2 Tylenol because the headache came back; slept a couple of times a day and had a good night's sleep. Next day, she was a little better but still in bed, she fed myself better. The next day she went to the doctor (prior appointment) and was prescribed Meloxicam and Tylenol 6 hours after and was getting better. The outcome of the events was recovered. Post vaccination, the patient has not been tested for COVID.
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| 71 | 2021-02-22 | limb discomfort |
Per patient: " I received my 2nd vaccine on Friday, February 12, 2021 and started breaking out on S...
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Per patient: " I received my 2nd vaccine on Friday, February 12, 2021 and started breaking out on Saturday, February 13, 2021 around my forehead and into my eyebrow. I developed body aches as well as a headache and arm soreness. I went to the dermatologist on Wednesday, February 17, 2021 and they cultured the lesions and results came back positive for shingles on February 22, 2021. I called the health department to let you know. "
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| 71 | 2021-02-23 | bone pain |
Initially on Friday onset of diarrhea, followed by fever to 101 if I remember correctly maybe slight...
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Initially on Friday onset of diarrhea, followed by fever to 101 if I remember correctly maybe slightly above that, cough, debilitating fatique and bone aches and chills and headaches lasting until almost 5 January. Second shot administered 01-18/2021 Pfizer Lot #EL3249 - again, significant fever, terrible chills and bone aches lasting approx 4-5 days.
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| 71 | 2021-02-23 | joint swelling, joint pain, muscle pain | Swelling of feet and ankles. Joint and muscle aching all over body. |
| 71 | 2021-02-23 | musculoskeletal stiffness, muscle pain |
Chills with violent shivering starting second night after vaccine and continued for 3 nights. Dren...
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Chills with violent shivering starting second night after vaccine and continued for 3 nights. Drenching night sweats overnight began the 3rd night and is continuing now but lessening slightly in degree. Headaches. Muscles ache and stiffness particularly in legs. Slight loss of balance from time to time. Loss of appetite. Rash on chest possibly caused by sweating at night. Increased severity when bruised.
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| 71 | 2021-02-23 | muscle pain, joint pain |
Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have...
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Dry cough; Sore throat; Diarrhea; Nausea; muscle aches; joint aches; extreme fatigue; Headache; have been sick ever since; flu like symptoms; hoarse; This is a spontaneous report received from a contactable consumer (patient). This consumer reported similar events for herself and her husband. This is the first of 2 reports. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 20Jan2021 at 10:15-10:30 (as reported), at single dose, for COVID-19 immunization, at the hospital. There were no medical history, family history and concomitant medications. The patient had no vaccinations within four weeks prior to the first administration of BNT162B2 vaccine. The patient reported that she and her husband had the Pfizer Covid 19 shot on 20Jan2021 (last Wednesday). She stated that they have been sick ever since. On 20Jan2021, the patient had flu-like symptoms and at 11:00, she experienced headache. On 21Jan2021, the patient experienced nausea, muscle aches, joint aches and extreme fatigue. On 22Jan2021, the patient had sore throat during the night and diarrhea. On 23Jan2021, the patient had dry cough. On an unspecified date in Jan2021, the patient was hoarse. The events did not require emergency room visit of physician office visit. The patient wanted to know if they should get the second shot. The outcome of the events "have been sick ever since", "flu like symptoms", headache, nausea, extreme fatigue and "hoarse" was not recovered; the patient was recovering from muscle aches and joint aches; the patient recovered with sequel from dry cough on 23Jan2021 and sore throat on 24Jan2021; the patient recovered from diarrhea on 24Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093716 Same reporter, suspect drug and events; different patients
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| 71 | 2021-02-24 | muscular weakness |
8:00 p.m. day of injection - Fever & Severe Chills. Chills eased about 3:00 a.m. 02/10/21 7:00 a.m....
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8:00 p.m. day of injection - Fever & Severe Chills. Chills eased about 3:00 a.m. 02/10/21 7:00 a.m. 02/10/21 - abdominal muscles and unable to function extremities very weak loss of bladder control improved very, very slowly until 02/11/21 - 3:00p.m. 02/11/21 return to normal 02/11/21. No lasting consequences
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| 71 | 2021-02-24 | muscle pain, joint pain |
Side effects, not anaphylactic adverse reaction. Chills, fever, muscle aches, bad headache, joint pa...
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Side effects, not anaphylactic adverse reaction. Chills, fever, muscle aches, bad headache, joint pain, injection site pain.
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| 71 | 2021-02-25 | muscle pain |
My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel we...
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My arm hurt; I started to get little tired; I couldn't watch TV; My stomach suddenly did not feel well; Nauseous; I got cold; Sick; was very hot and so hot; was round up/she was feeling she would faint; waves of feeling like i would pass out; it was just being very hot, then being cold; Blood drained from my head, I just knew I was going to pass out; I took 0.2 rather than the 0.3ml of the first dose; very fast heart rate intermediately for many day; squeezing of chest; muscle hurting/Pain in my body in every muscles, my fingers, my hands, my calves, my feet, my back, neck, everything; digestive disorders; feeling gassy, uneasy; stomach abdomen was just tight; abdominal issue; feeling gassy, uneasy; stomach abdomen was just tight; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: E18982), on 21Jan2021 (at the age of 71-year-old) at single dose for COVID-19 immunisation. The patient reported that based on her history of reactions to medications, the nurses giving injections "decided 0.2ml instead of 0.3ml", which is what they gave, so she got 0.2 that is two-third of the shot. The 2nd shot was for 8'oclock on 11Feb2021. She is very sensitive to shots, vaccines, and to all medications and injections and things like that. She has sensitives thanks to two concussions she had in her life. She never was before that she had two concussions. Second one had a crazy man hit her after that just noticed that just have reactions not adverse or dying but definitely take rest of everything. So she take less of a shot, like a dental shot or cortisone shot, which she had taken in the past. If she has dental shot she cannot take Novocain, had to take Carbocaine or Marcaine and they give her half. Also she had been taking cortisone shot for shoulder for rotator cuff injury. They also have to give her less. Or flu shot: she takes half one week and come back for the other half the next week. Just have reactions. She told to when arrive for medication and did have one anaphylactic reaction but that was to cat skin dye, was told to this two nurses who was administering the vaccine and said to them she was really afraid to take. It is just too much for her. She knows her body. She is sure have reaction but is really afraid and don't know what is the first one will do to her. They just did two nurses and she decided that she will be taking 0.2 instead of 0.3ml which is what they gave. She got 0.2 so that two third of the shot and waited the half an hour, a nurse watched her card and 7 other cards. She did not have the anaphylactic reaction. She went home. Her arm hurt and started to get little tired. The events started the day that she got the shot. Like about 3 or 4 hours later. It is just few hours later she couldn't watch TV so went to laid down and an hour later she woke-up. She walked to her kitchen and blood drained from her head, she just knew she was going to pass out. Her stomach suddenly did not feel well. She tried to get back her bed but she was round up and as far as the bathroom. She got very nauseous, she laid down on bathroom floor. She thought she was sick but didn't round up having to use toilet of few times. Although while she was feeling she would faint. She was very hot and so hot. While lie down, she couldn't even pulling off her pajamas. So when she got cold so she was pulling a towel down and stop and she laid to for two hours, she finally got to her bed. It was a terrible experience. Next day she drank water and had potatoes prepared and went up eating back to later baked potatoes. Next day luckily she did not have repeat of the nausea. She didn't have that anymore of. She did have abdominal issue just not diarrhea or anything but just not feeling well, feeling gassy, so uneasy. This all lasted, that part lasted for 7 days. What concerned her was especially beside first day it was few days she got off again. She was just feel blood drain but not this first time she laid on floor. She couldn't sit on chair to watch TV for about 3 days. She mostly laid on bed but she would get very hot and then very cold during the day. She would get very fast heart beat not continue but really fast like heart was pounding her chest. She felt like someone has their hand inside her body squeezing her chest. She got afraid but didn't want to go hospital. She didn't think she was sick enough. She was concerned. So that was happened and this last was for about 7 days. Then the squeezing of chest part went away. She doesn't want to wind-up on the floor feeling that sick again, she felt so sick it felt like food poisoning. After that, it was just being very hot, then being cold, the fast heart rate, every muscle hurting. Those were the main things that continued for a week. And digestive disorders. It all lasted for about 13 days. She was concerned she had a very fast heart rate intermediately for many days, for about a week. And that's considered an adverse reaction and also she was getting waves of feeling like she would pass out, everything would drain from her head. She experienced stomach ache, feeling hot then cold. She wants to do precautions before taking the second dose on 11Feb2021. She did take may be 3 days later two Tylenol but didn't take anything (clarification requested). She didn't even take vitamins during that time. She was afraid to take anything so she did not. At the same time also there was pain in her body in every muscles, fingers, hands, calves, feet, back, neck, everything. Her stomach abdomen was just tight. She was concerned that last for few days. In last few days she started feel herself and now she is going again tomorrow. So that how she reacted. She doesn't know how much of this shot she told them she could tolerate because everybody is saying second shot will give you more reactions. All she can take this more than that because that was lot. She wants to be herself, don't want laying on floor, don't want to have 105 temperature or anything. The patient was asking if she should take another 0.2ml another two-third of the shot. She just asked them for half that is 0.15 would that be a big difference. She needed to know by 8 o'clock tomorrow. I might be in a queue to get it. She stated: 'So, that's my concern. I'm all alone, I'm a senior, I have no family. I lost my mother to covid. I know I need this vaccine, but I just, I cant get that sick and I'm so afraid I'll wind up with a 105 something, fainting away and no one knowing'. She was asking if reactions after the 2nd dose are worse than the 1st dose, if she didn't have anaphylaxis after 1st one, she shouldn't have it a 2nd time, right. She said, "1st half of flu shot, I get sick, then the 2nd half nothing". She also asked if she can take medications after the vaccine, like Tylenol, or irritable bowel syndrome (IBS) medication she takes as needed. The events resolved, but the patient reported it took her like 13 days before she felt better.
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| 71 | 2021-02-26 | muscle pain |
I received the first Pfizer vaccine t 2:45 PM on Thursday, 2/25/21. That night when I went to bed I ...
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I received the first Pfizer vaccine t 2:45 PM on Thursday, 2/25/21. That night when I went to bed I felt chilled and woke up several times feeling chilled. In the morning I felt sick with similar symptoms as when I had COVID-19 in March2020. I had head pains, inner ear pains, naseau, sore muscles, and extreme fatigue. I slept the whole day, waking up and going back to sleep. I dranka little, but just didn't feel like it. I ate a piece of toast with butter that evening and then felt naseauated. I slept through the night and woke up feeling a little better the next day, but still feel tired and have some pains in my head.
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| 71 | 2021-02-27 | joint pain |
12.45 hours after 2nd dose: fever, chills, shaking, joint pain, HA, lethargy, tired; Symptoms lasted...
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12.45 hours after 2nd dose: fever, chills, shaking, joint pain, HA, lethargy, tired; Symptoms lasted 2-3 days, but the following symptoms are still present (10 Days post 2nd dose): HA, lethargy, fogginess and tiredness
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| 71 | 2021-02-27 | joint pain | Moderate to severe pain in right wrist, fingers & arm |
| 71 | 2021-02-28 | armpit pain, neck pain |
Within first 30hrs of receiving vaccine: chills (twice), body aches, diarrhea (twice); fatigue, fev...
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Within first 30hrs of receiving vaccine: chills (twice), body aches, diarrhea (twice); fatigue, fever (did not exceed 100 degrees). Underarm pain, enlarged lymph node began within 2 days post 2nd vaccine. ( Friday-Sat. Feb. 26-27) Within four days (Sunday Feb. 28) redness, swelling, pain and itching began in upper arm. ....neck pain reduced. By Monday, March 1, I contacted my family practice clinic and received a video consult with Dr.
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| 71 | 2021-02-28 | muscular weakness | strength difficulty, tiredness, leg weakness, |
| 71 | 2021-03-01 | joint swelling | Hives at various locations around my body, swollen hands, knees, lips - ongoing problem |
| 71 | 2021-03-01 | muscular weakness |
patient reported numbness in her upper deltoid muscle on the side of vaccination initially. After 5 ...
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patient reported numbness in her upper deltoid muscle on the side of vaccination initially. After 5 minutes the patient reported feeling a little short of breath and that her heart rate felt fast. Patient remained alert and oriented throughout. Patient was given water and instructed to perform pursed lip breathing. When attempting to move patient to a private space, she reported weakness in her legs and required assistance to transfer to a wheel chair. 911 was called when patient reported trouble breathing that was not improving. Patient also reported a history of anxiety and congestive heart failure. Patient was transported to a local emergency department via ambulance for further evaluation. Patient was transported away from our clinic at 10:15am.
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| 71 | 2021-03-01 | neck pain |
48 hours after shot in left arm I started to have a earache on left side, traveled down the left sid...
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48 hours after shot in left arm I started to have a earache on left side, traveled down the left side of face, into jaw area and down left side of my throat like tonsils and into neck area. Into 72 hours after shot my face, neck and throat area started swelling. At that time I went to ER for assistance due to the swelling and pain. The ER after taking review thought it a infected saliva gland and treated me for that. As told by ER if no large progress contact my local Dr. and see ENT. On Tues. (one week from Covid injection) I was in touch with my local Dr. they had me come to their office for some care and scheduled me with a ENT. They have been able to get the profuse swelling down out of the left side of my face, neck and throat. I'm scheduled for a CT scan on March 5, 2021 to see where the original problem started. I'm contacting you for two reason's 1. I have a March 10th. appointment scheduled I need to cancel and am having issues doing this. Even in light of all this I want to reschedule for late April for my second shot and am not able to do that as well. 2. Can you assist with any information if this has happened to other folks and if I should be clear to take my second dose. This has been quite a nightmare and hard to bring under control. I believe in the vaccine and this maybe just a quirk in how it happened but any information you can give me would be welcome. I have looked on the website and it does say that there have been people who have also had symptoms like this from the shots where the side they get the shot on reacts. Thanking you in advance for your time and assistance.
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| 71 | 2021-03-02 | muscle pain |
Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a co...
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Nauseous; Weak; Really unwell; Tired; Muscle aches; Headache; This is a spontaneous report from a contactable consumer. A 71-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: CN5318, via an unspecified route of administration at right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. Medical history was not reported. Historical vaccine included first dose of BNT162B2 on an unspecified date. There were no concomitant medications. On 29Jan2021, at 7 pm, the patient was nauseous and weak. At 9 pm, the patient was really unwell, tired, headache, muscle aches and nausea. She slept all Friday night, all day Saturday. Late around Sunday was finally able to get out of bed. Asked if she should see a doctor. The patient was still nauseous and weak. The outcome of the events nausea and weak was not recovered. The outcome of other events was unknown.
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| 71 | 2021-03-03 | joint pain |
Received shot on 2/27 2/28 & 2/29 fever , chills, joint aches, headaches, took Tylenol for fever 2/3...
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Received shot on 2/27 2/28 & 2/29 fever , chills, joint aches, headaches, took Tylenol for fever 2/30 rash started at injection site. I took Benadryl but rash spread and got worse 3/4 went Emergency center for worsening rash, sever itching, and unable to sleep. I was given a Benadryl 25mg injection and a steroid shot. I was to continue taking Benadryl and set up an appointment with my PCP.
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| 71 | 2021-03-03 | back pain, joint pain | Severe Headaches Severe joint aches Severe back pain Fatigue Symptoms lasted 7 days |
| 71 | 2021-03-03 | limb discomfort |
Left arm about 2 hours after shot got very heavy. Hand and fingers numb and tingled for about 15 min...
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Left arm about 2 hours after shot got very heavy. Hand and fingers numb and tingled for about 15 minutes then was ok After 1 hour I had I think like brain fog and hard time to navigate my phone. Seem just like confused or light headed kind of during day. Misplaced phones or things next day Next day at night just felt around 11pm getting ready for bed my head was ok and I could think ok again
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| 71 | 2021-03-04 | joint pain |
had chills, sweat, body aches, joint pain, headache. by Sunday I was fine and then Tuesday I develop...
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had chills, sweat, body aches, joint pain, headache. by Sunday I was fine and then Tuesday I developed the worst headache of my life and my face swelled up and my eyes got puffy and I was really sick. I had joint pain and sweats and chills again.
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| 71 | 2021-03-04 | muscular weakness | Bell?s palsy. Left eye will not close and left mouth droopy with muscle weakness left side. |
| 71 | 2021-03-05 | back pain, joint pain, muscle pain |
This was the second shot in series of 2. First shot only gave me a sore arm at site & was administer...
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This was the second shot in series of 2. First shot only gave me a sore arm at site & was administered on February 6, 2021. Second shot was administered on March 3, 2021. Started feeling these adverse effects about 9 or 10 am the following morning, 3/4/2021. Symptoms were soreness at site, in muscle that goes to the neck, headache, soreness across upper back/shoulder to shoulder. By 4 pm on 3/4, my entire body was reacting with extreme joint pain in all joints, extreme joint stiffness, skin was tender to the touch, temperature of 100.1, sore/stiff neck, and continuing headache. Temperature ceased around 11:30 pm but all other symptoms remained upon going to bed at 1 a.m., 3/5/2021. Upon waking at about 7:30 am 3/5/2021, all symptoms had diminished enough for me to go to an appointment at 10:45 am. However, by the time I headed back home at about 1:30 pm, I was so sleepy I could hardly keep my eyes open. More stiffness and achiness had returned too, especially a sore left underarm. Not the extent of night before, but enough to be uncomfortable. Today, 3/6/2021, I have noticed a sore muscle traveling from my left underarm down to my waist.
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| 71 | 2021-03-06 | joint pain | Left arm swollen Body ache Dizziness Increased joint pain |
| 71 | 2021-03-07 | joint pain, muscle pain |
Low grade fever, chills, flu-type aching, loss of appetite, extreme fatigue, pain at injection site,...
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Low grade fever, chills, flu-type aching, loss of appetite, extreme fatigue, pain at injection site, joint and muscle pain. The worst of it was the Wednesday after late Monday afternoon vaccination; ie on day two post-vax. Felt like a case of bad flu. Lasted about 2 to 3 days, with tapering severity. A week later, energy level is still down; sleeping more than usual.
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| 71 | 2021-03-07 | back pain |
Shingles on torso after 2nd dose. Started at navel, then around right side to spine, then back. Pain...
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Shingles on torso after 2nd dose. Started at navel, then around right side to spine, then back. Painful. No headache/fever, SOB. Backache prior to shingles
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| 71 | 2021-03-07 | joint swelling |
After receiving the first dose of vaccine at 5:30 pm noticed swelling around and below elbow with re...
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After receiving the first dose of vaccine at 5:30 pm noticed swelling around and below elbow with resdness and warmth to touch. Denies pain
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| 71 | 2021-03-07 | musculoskeletal stiffness, neck pain |
About 30 min after injection, tendon in my neck, left side began to warm, then, the warmth rose to ...
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About 30 min after injection, tendon in my neck, left side began to warm, then, the warmth rose to the base of scull. I started rotating neck, but continued for about 30 minutes. My neck on that side became stiff and painful. I continued throughout the pm to exercise my neck . By bedtime, it was no longer warm. Still slightly stiff, next morning, a bit stiff. By 36 hr, totally back to normhe, I am an RN, retired & daughter is RN, active, didn't see reason to contact Dr.
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| 71 | 2021-03-08 | joint pain |
Swelling; redness; soreness down to the elbow; This is a spontaneous report from a contactable consu...
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Swelling; redness; soreness down to the elbow; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 25Jan2021 11:00, at single dose, for covid-19 immunization. The patient has no medical history. Concomitant medications included estradiol (VAGIFEM) and, vitamins. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The vaccine was administered in the hospital. The patient experienced swelling; redness; and soreness down to the elbow - all on 01Feb2021. The patient had not recovered from these adverse events and; no treatment was received for them. The patient has not been tested for COVID-19 since the vaccination. Information about the lot/batch number has been requested.
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| 71 | 2021-03-08 | joint pain | Fever and Chills body aches joint pain Runny nose diarhea |
| 71 | 2021-03-08 | back pain, muscle pain |
Very sensitive now to regular meds; lower back felt really heavy; pounding sensation up and down my ...
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Very sensitive now to regular meds; lower back felt really heavy; pounding sensation up and down my torso; feeling of muscle heaviness that I almost felt paralyzed; extreme body ache; chills; I had a bad headache; stinging on both sides of my head and on hands and feet; was very lethargic; arm became real sore and was painful; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, expiry date not reported), via an unspecified route of administration on the left arm on 27Jan2021 10:30 at single dose for covid-19 immunisation. Medical history included mild lupus, post concussion syndrome (PPCs) and allergies: sulfur (very sensitive to large doses) from an unknown date and unknown if ongoing. Concomitant medication included esomeprazole magnesium (NEXIUM), tramadol, alprazolam and acetylsalicylic acid (ALKA SELTZER). The patient reported that after just a few hours on 27Jan2021, their arm became real sore and was painful to use until next morning, was sore for 2 days. Hurt after much normal use. Woke up on the morning of 28Jan2021 (3 am) with chills, extreme body ache and feeling of muscle heaviness that they almost felt paralyzed. They could still move. They had a bad headache and stinging on both sides of their head and on hands and feet. They took aspirin and went back to sleep. When they got up they felt some better, but did not feel well and was very lethargic. That night they took another aspirin before bed. On the morning of 29Jan2021 (second day ) they again woke up at 3 AM to extreme body ache, the same heavy paralyzing feeling, but this time their lower back felt really heavy and there was a pounding sensation up and down their torso. They repeated the aspirin dose and went back to bed but did not sleep anymore that day. They did feel some better but still very lethargic. Next day better, but took 5 days to feel some normal w/o fatigue. The patient is very sensitive now to regular meds. Therapeutic measures were taken which included aspirin. The patient was recovering from feeling of muscle heaviness that I almost felt paralyzed, extreme body ache, chills, headache, stinging on both sides of my head and on hands and feet, lethargy recovered from arm became real sore and was painful on an unspecified date, while the outcome of the other events was unknown. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID since vaccination.
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| 71 | 2021-03-08 | muscle tightness, neck pain, joint pain |
The shot was given to me (Sat) in the upper (L) arm about 2 -1/2 inches down from top of shoulder. ...
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The shot was given to me (Sat) in the upper (L) arm about 2 -1/2 inches down from top of shoulder. It was a simple prick however I thought it seemed an odd location. About 24 hours later (Sun) I felt first signs of tenderness at the site but didn't think much of it as that is what I had heard from others about the vaccine. Later in the day it became achy. On Monday morning I noticed my whole arm was achy in addition to the top of my shoulder and the left side of my neck and upper shoulder blade. At 9:30 am I felt very tired and laid down and awoke 4 hours later! My aches were still all there as though I had slept wrong. Again I was not too concerned except that my friends all said their discomfort was gone within 24 hrs. Today is Tuesday and evening and as I sit here I have a very tender, sore, achy upper left arm and a small black and blue spot at the site. It's strange because it doesn't hurt when I touch it, instead it is just an ache/pain that I feel and especially when I move the arm. The tightness and ache in my neck and back and shoulder has lessened. I am reporting as I was not expecting this type of reaction especially to last 3-1/2 days so far. I feel this adverse reaction probably has more to do with the location that the technician chose to give me the vaccine. I am thinking the muscles are reacting to injection.
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| 71 | 2021-03-08 | muscle pain, joint pain | Chills, Headache, Myalgia, Arthralgia, Fatigue, Rash on forearms |
| 71 | 2021-03-08 | muscle pain |
fever of 101.9 for 2 full days- lessened on 3rd day-, headache, nausea, chills, muscle aches includ...
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fever of 101.9 for 2 full days- lessened on 3rd day-, headache, nausea, chills, muscle aches including my fingers, runny nose, sore skin to the touch on left lower arm. Sore skin did not occur until 4th day. very fatigued throughout. All symptoms gone by end of 4th day.
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| 71 | 2021-03-08 | neck pain, back pain, joint pain |
With my first vaccine shot on 2/1/21 I developed a small itchy spot on my neck immediately following...
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With my first vaccine shot on 2/1/21 I developed a small itchy spot on my neck immediately following injection. The doctor on site recommended waiting there at the hospital to monitor it for a few minutes, and I did, and the spot went away. My second vaccination was 2/24/21 and the next day, around noon, I started to have a back ache. Late afternoon I became a little light headed and slightly queasy. That night the pain started in my joints - neck, shoulders, all down my back. They became rather intense, and at one point during the night, after I had managed to fall asleep, I was awoken with burning pain in both elbows, and random sharp pains in toes and fingers. I took Tylenol through the afternoon and night. The following day I was still sore, but not in pain. Then all symptoms disappeared. Not severe enough to seek medical attention but thought I ought to report symptoms for medical research reasons.
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| 71 | 2021-03-09 | joint pain | Sore shoulder same day. Fatique on second day. No other symptoms. |
| 71 | 2021-03-10 | joint pain, muscle pain |
beeps, noise in her ears; muscle and joint pain; muscle and joint pain; tongue was a little numb; fa...
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beeps, noise in her ears; muscle and joint pain; muscle and joint pain; tongue was a little numb; face lips; felt paralyzed/Felt like I couldn't move it like paralyzed a little bit; whole left side of body started going numb/Left side was numb around 7 or 8 that night/all left side was numb; pains in all of her face; pain and soreness in arm/arm was painful; tachycard, high heart rate; very tired, sleepy; very tired, sleepy; headache, heavy in her head; pain in both ears; This is a spontaneous report from a contactable consumer (patient). This 71-years-Old female patient received the first dose of (Pfizer Biontech Covid 19 Vaccine, Lot No. EN6198) intramuscularly at single dose on 23Feb2021 for COVID-19 immunisation. Relevant history and concomitant drugs were unknown. Past dug included flu vaccine in Sep2020. The patient received her first dose of Covid 19 vaccine on 23Feb2021 at 3:30 in the afternoon. She came home and felt, not bad at any time but more or less towards 6:00 or 7:00 at night she started feeling bad. Her whole left side of body started going numb around 7 or 8 that night. Her arm was painful, face lips and all left side was numb. Felt like she couldn't move it like paralyzed a little bit. Clarified as whole left side, even her leg, her feet everything on that left side. She started feeling pains in bones of head, especially her face, clarified all of her face and her left side was numb even her lips on the left side were numb. Her tongue was a little numb. She had muscle and joint pain. The pain, of course, in the arm, but that was normal. Clarified pain in the arm as the injection site. She didn't feel any swell there. She did not take medication for anything. She used a lotion. The lotion was trividol aloe vera arnica caleudula and helped to relive the pain. The arm was still a little painful but it's not bad but that feeling made her tachycard, clarified as high heart rate, feeling like boom boom boom, but she did not have any shortness of breath. The high heart rate was gone the same day. She had no fever or chills. She felt very tired and slept for about 10 hours but during the sleepy she started feeling a headache she couldn't get up because she was so tired and she felt pain in both ears. She had not been to the doctor in a while. She was still old fashioned so she carries everything in a little telephone book. While trying to read information caller states she had to change her eyes. She still felt numbness in left side of left leg but she thought it might be because she had not been exercising. When she was waking up around 9am in the morning, it was yesterday that she felt better in regards to the paralyzed feeling. When pains in her face came she felt and she thought what is this? It only lasted for a little while. It was during the night. The pain and soreness in arm at injection site is still there, she did not feel any swelling, or hot at that site. She confirmed she still felt a little tired, sleepy. It's getting better. She may feel a little heavy in her head and would like to go to sleep, but she was not sleeping. She had many things to do and knew she had to be up. The headache went away and was gone on 24Feb2021. It was persisting for a while, not too hard or heavy, but it resolved by 2 or 3 in the afternoon on the 24th. In regarding to pain in ears she mentioned she no longer had. She had beeps, noise in her ears even at the time she went to bed it was better. The outcome of events paralyzed, pain in arm, tired, sleepy, was recovering, the outcome of events tachycard, pains in all of her face, pain in both ears was resovled, the outcome of other events was unknown.
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| 71 | 2021-03-11 | joint pain | Joint pain over entire body, chills, nausea, bad headaches, site redness and tenderness,. |
| 71 | 2021-03-11 | joint pain |
Swollen lymph nodes, fever for three days, body aches covering entire body and joints, fatigue, head...
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Swollen lymph nodes, fever for three days, body aches covering entire body and joints, fatigue, headache. All events lasted for three days
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| 71 | 2021-03-12 | joint pain, back pain, musculoskeletal chest pain |
Awoke 3/12 with pain in left back covering an area about 8" by 8", all on the ribs. Would not have t...
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Awoke 3/12 with pain in left back covering an area about 8" by 8", all on the ribs. Would not have thought it was related to the vaccine, except that the exact same pain showed up 2 days after I got the first vaccine, and I have never had it before. Lasted 3-4 days-faded away. (Did not report at that time - thought I had strained something.) Very painful, does not appear to be muscular, heat does not help. Hurts much worse with breathing in deeply, any movement. Also have pain in left ankle radiating up the inside of the leg, which I also had with the first shot and at that time attributed to new shoes, which had also gone away weeks ago.
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| 71 | 2021-03-12 | joint pain | Chills, headache and all joints aching |
| 71 | 2021-03-12 | neck pain, musculoskeletal stiffness |
Dull headache for one week and advil would not help. After the headache was gone I have a severe sti...
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Dull headache for one week and advil would not help. After the headache was gone I have a severe stiff and extremely painful left side of my neck. Have used heating pad and no I have on pain patches.
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| 71 | 2021-03-12 | neck pain |
Pfizer-BioNTech COVID-19 Vaccine EUA. Swollen lymph gland at base of neck, left side. Day after...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Swollen lymph gland at base of neck, left side. Day after 2nd shot, collar bone was sore and a lump had developed where collar bone meets neck. Quite swollen lymph node. It has been two weeks since 2nd shot and swollen gland has not changed. Still swollen.
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| 71 | 2021-03-13 | muscle pain, joint pain |
Developed slight headache about an hour after shot. Then 7:00 PM was hit with bad case of nausea. ...
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Developed slight headache about an hour after shot. Then 7:00 PM was hit with bad case of nausea. Had nausea meds and took one which calmed things down. Then at 3:00 AM on 3/13 2021 was hit with nausea again.. Took more meds for nausea and have been fine ever since. Developed overall Muscle Aches (not joint aches!) all day Saturday 3/13/2021. Still have some muscle aches today 3/14/2021. Left arm became sore on Saturday 3/13/2021 and whole left shoulder is sore today (3/14). Otherwise feel great!
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| 71 | 2021-03-13 | muscle pain |
intense headache, muscle pain, chest pain, chills, nausea, vomiting, lightheadedness, lethargy I to...
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intense headache, muscle pain, chest pain, chills, nausea, vomiting, lightheadedness, lethargy I took Tylenol Extra Strength tablets for the headache & muscle pain. The headaches lasted for 3 days. The muscle pain for 3 days. The vomiting occurred on the day after the shot - 1 time. I remained nauseous for the next 3 days. The chest pain has been on and off for the past 2 days. It has been mild. The lightheadedness lasted for 4 days. The lack of energy is still ongoing, but is getting better.
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| 71 | 2021-03-14 | muscle pain |
Pt had her 1st covid-19 vaccine on March 8th -increased fatigue and muscle pain -increased Rhochi ...
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Pt had her 1st covid-19 vaccine on March 8th -increased fatigue and muscle pain -increased Rhochi Affects Pt to continue breathing treatments and immune boosting regimen - pt is going to have chest xray
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| 71 | 2021-03-15 | joint pain |
Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to conce...
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Circulatory burning within 10 minutes, blurry vision, chest pressure, confusion & inability to concentrate , extreme weakness & fatigue, extreme focused joint pain, headache, coughing and difficulty breathing requiring multiple nebulizer uses every 2 hours over 2 weeks, headache. Face & body rash, . Persistent exhaustion continues requiring 2-3 hour daily naps & non Fibro brain fog continues at 3 weeks.
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| 71 | 2021-03-15 | muscle pain |
originally after the shot I had slight discomfort at the injection site. A week later, I had a red,...
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originally after the shot I had slight discomfort at the injection site. A week later, I had a red, raised, inflamed area--an 8 inch band around my upper left arm, over the injection site. It itched. I also had severe muscle aches in my neck and shoulders. It lasted 2 days.
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| 71 | 2021-03-15 | neck pain, muscle pain, joint pain |
I am having increasingly bad pain in both arms, wrists, hands, knees, neck. My pain in especially ba...
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I am having increasingly bad pain in both arms, wrists, hands, knees, neck. My pain in especially bad at the injection site. The first shot on Jan 11 caused a terrible sore arm that only lasted a day, the second shot on Feb 1 caused a sore arm that lastsd 3 days, then this full body pain began and has not abated (45 days). The pain is spreading now to my quadriceps and my calf muscles and the pain seems to be mostly in muscles or tendons. Someone suggested I had RA but my joints (except wrists) are good. I'm taking Ibuprofen every 4 hours. I did a 5 day blast of 50MG prednisone about 3 weeks ago and that helped a lot, but pain is back and worse.
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| 71 | 2021-03-16 | bone pain, joint pain, muscle pain |
8 hrs after shot got sore joints, bones, and muscles, head ache, chills, fever up to 101. Fever brok...
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8 hrs after shot got sore joints, bones, and muscles, head ache, chills, fever up to 101. Fever broke 8 am the next morning. Soreness for the next 2 days. tired for 4 days.
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| 71 | 2021-03-16 | muscle pain |
3/10/2021-Shot given at 9:30 AM. in the afternoon was very tired and achy. Had a headache and gland...
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3/10/2021-Shot given at 9:30 AM. in the afternoon was very tired and achy. Had a headache and glands felt swollen.Took a 2 1/2 hour nap. 3/11/2021- Flu like feeling. Pounding headache, tired, sore muscles, injection site was sore, low grade temperature.( 99.9, 99.5, 100) 3/12/2021- Headache,feeling tried and unwell. Injection site very itchy and staring to swell 3/13/2021-two areas on the left arm are swollen and very itchy. Top swelling in arm near the injection site. Lower swelling is 2 inches by2 inches large 3/14/2021-Swelling in arm increased to 3 inches x 3 inches at the widest spots. Arm was red, hot to the touch and very itchy. 3/15/2021-Swelling in arm was the same. Call Dr. Was told I had " COVID arm"
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| 71 | 2021-03-17 | joint pain, neck pain | Soreness in arm, shoulder and neck |
| 71 | 2021-03-17 | joint pain |
Patient reports she is a medical assistant, and that vaccine given to close to the AC joint. Patien...
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Patient reports she is a medical assistant, and that vaccine given to close to the AC joint. Patient now has bursitis. Significant pain in shoulder and arm. would like another dose of vaccine.
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| 71 | 2021-03-18 | joint pain, muscle pain |
3/8 Red welt with mild itching . Slight arm muscle soreness. Still bothersome 3/19! 3/9 Day after sh...
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3/8 Red welt with mild itching . Slight arm muscle soreness. Still bothersome 3/19! 3/9 Day after shot felt like I'd been hit by a truck. Everything joint & muscle hurt! Better on 3/10.
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| 71 | 2021-03-18 | joint pain |
I woke up at 3am with pain in my shoulders.. Soon after I felt sharp pain in random places and times...
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I woke up at 3am with pain in my shoulders.. Soon after I felt sharp pain in random places and times in my body, and I would shake shortly at random time. As time went on the pain seemed to move down my body from my shoulders to my arms then my hands and then to my legs. I fell back to sleep for a couple hours and woke with sharp random short pains and continuing aching in my joints. I noticed my speech was gravelly. I had no appetite and did not eat at all that day. I mostly slept. When out of bed I felt very weak so was up for only short times. I took one alleve pill because I was so uncomfortable. I was not hot and did not have a fever. When I woke in themorning on 3/19/21 all that pain was gone and I felt very rested.
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| 71 | 2021-03-18 | back pain, muscle pain |
Chills; weak; couldn't get warm; fatigue; vomited; tired and lethargic; muscle pain; Low back pain; ...
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Chills; weak; couldn't get warm; fatigue; vomited; tired and lethargic; muscle pain; Low back pain; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unspecified if 'EL9264' or '3L9264'), via an unspecified route of administration, on 09Feb2021 01:30PM at a single dose on the right arm for COVID-19 immunization. Medical history included thyroid disease (was diagnosed in her 40s, 30 years ago) from 1991, blood pressure high (was diagnosed in her 40s, 30 years ago) from 1991, mitral valve prolapse from 2001 (was diagnosed about 20 years ago), little heart disease (which she was told was nothing to worry about), her heart running away from her (They did extensive heart tests and pictures, all that stuff, put her on a medicine called Atenolol which makes her heart beat regularly and not have spells while she is walking of her heart running away), and double knee surgery three years ago (2018) when they put in false knees. Concomitant medications included levothyroxine sodium (SYNTHROID) for thyroid disease, atenolol (ATENOLOL) from 1991 for 'her heart running away from her' (She has been on atenolol 30 years, since she was 40 something. It is good medicine, and she doesn't have her heart running away.), tramadol (TRAMADOL) for double knee surgery three years ago (2018) when they put in false knees, and she also takes two high blood pressure medications. The patient added that all of the medications she takes she has been on about 30 years. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), on 18Jan2021 01:30PM on the right arm for COVID-19 immunization. The patient reported that she had received both doses of the Pfizer COVID-19 vaccine. She has been told that the AEs (adverse events) associated with the vaccine would happen within 12 hours. However, her AEs had been occurring in stages. On 10Feb2021, she had muscle pain. On 11Feb2021, she woke up and threw up and was in bed all day having fatigue. At the date of report, 12Feb2021, she was still on her bed, tired, and having chills. She wanted to know if it is normal to have these reactions 3 days after the shot. She further reported that she got the second dose. And after feeling wonderful after the first dose, she got the second dose on 09Feb2021 and later that night her lower back was killing her. She later clarified that she had low back pain. She stated that she knows that part of side effects that she read for when someone got the shot was that they can have a headache and she was told side effects should only last 12 hours. She stated that on the 11Feb2021, she woke up that morning and couldn't make it out of bed and vomited, then had to get up and clean her bed and put on new sheets. She only vomited once. She stated she has been so tired and lethargic that she stayed in bed all day on the 11Feb2021. At the time of report, on February 12Feb2021, she was having chills, she couldn't get warm, and she didn't have a fever, but she is still weak. Since she was told side effects would go away within 12 hours and this has been three days, she asked if what she was experiencing was normal. As for corrective treatment the patient reported that she also takes tramadol since she had double knee surgery three years ago (2018) when they put in false knees; that's when she started taking Tramadol for that. She said she also took it for the back pain which it kept it at bay until it wore off. Her lower back pain is already gone at the time of report; she was just having chills still and was tired. She stated she has had so many symptoms on different days that she was just questioning. She stated that everyone else who was sick with the second dose it lasted 12 hours, and her friends who really got sick with it, hers is minor, but she would like to know if it is normal that it is still lasting. Outcome of the event low back pain was recovered on an unspecified date in Feb2021. Outcome of the events weak, couldn't get warm, chills and tired was not recovered. Outcome of the other events was unknown. Information on batch number has been requested.
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| 71 | 2021-03-18 | muscle pain |
Extreme muscle pain and slight headache which was gone by 3/18/2021. Hurt to even turn head. Spike...
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Extreme muscle pain and slight headache which was gone by 3/18/2021. Hurt to even turn head. Spike in blood pressure on 3/18/2021 to 191/91. Returned to 152/71 on 3/19/2021.
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| 71 | 2021-03-19 | joint pain, armpit pain |
Swollen and very tender lymph node in left armpit midday 3/19. Increased as day progressed moving do...
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Swollen and very tender lymph node in left armpit midday 3/19. Increased as day progressed moving down to include elbow. Elbow tenderness, not swelling. Morning 3/20, Swelling spread to include inside upper arm. Tenderness increased from armpit to further toward back.
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| 71 | 2021-03-19 | back pain |
A few days after injection low grade fever - 99-100 degrees F, fatigue, severe aching neck and back...
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A few days after injection low grade fever - 99-100 degrees F, fatigue, severe aching neck and back After about 7-8 days intense itching arm, raised red area, swelling at injection site. Still with me today
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| 71 | 2021-03-20 | joint pain, bone pain, muscle pain | Tremendous bone, joint, muscle aches Treatment: 3 Acetaminophen |
| 71 | 2021-03-21 | back pain, joint pain, muscle tightness |
Within the 24 hours after I experienced an intense tightening of my back between my shoulder blades ...
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Within the 24 hours after I experienced an intense tightening of my back between my shoulder blades and more to the right side. It was painful breathing in fully, taking a deep breath, lesser so when I breathe shallowly. I felt very weak overall with multiple joints feeling pain (ankles, knees, wrist that was previously injured). The intensity of the back/between shoulder blades pain remained throughout the following day and a bit lesser so into day three (now).
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| 71 | 2021-03-22 | muscle pain |
Headache, muscle aches, hypertension beginning 3 days after shot lasting for 1 week after first shot...
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Headache, muscle aches, hypertension beginning 3 days after shot lasting for 1 week after first shot, lasted 12 dats after 2nd shot
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| 71 | 2021-03-22 | neck pain |
First dose was uneventful. After the second dose of vaccine I experienced neck and back of head pai...
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First dose was uneventful. After the second dose of vaccine I experienced neck and back of head pain. It's always there. Ibuprofen does not take the entire ache away. Hoping that this will subside. Trying massage, yoga, and home heat massage. It's like a tooth ache.
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| 71 | 2021-03-22 | neck pain | FLU LIKE SYMTOMS, EXTREME PAIN IN NECK, EAR AND FACE |
| 71 | 2021-03-23 | grip strength decreased |
15 minutes after shot, numbness in lips, itchy mouth and throat, within about 5 more minutes throat ...
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15 minutes after shot, numbness in lips, itchy mouth and throat, within about 5 more minutes throat tightness, sensation of difficulty swallowing. Then abdominal pain, nausea, then feeling of something really wrong, I didn?t feel well, then got weaker and weaker, couldn?t lift arms, and felt extremely fatigued, trouble staying awake. Taken by ambulance to medical center. On route, ambulance stopped and another team came in. I was given epinephrine, zofran, Benadryl, and maybe a steroid? Not sure. When I arrived at hospital, t think I was given dexamethasone and famotidine. I was barely awake but could speak. Could not hold anything. After several hours, they woke me up, I felt myself again, and I was discharged. Following days I felt exhausted and dizzy, and had a headache. Took prednisone for five days.
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| 71 | 2021-03-23 | muscle pain |
The patient initially presented (3/3/21) with headache, fevers, nausea, vomiting, diarrhea, myalgias...
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The patient initially presented (3/3/21) with headache, fevers, nausea, vomiting, diarrhea, myalgias, malaise. Patient related she was in her normal state of health and only started to feel poorly after she received her second COVID-19 vaccination three days earlier. She interestingly related that after her first Pfizer COVID-19 vaccination she had significant burning in her stomach that she noted but no other major symptoms and notably did not experience this severe burning in her stomach after the second dose. She denied any chest pain, current dyspnea, productive cough, sore throat, urinary symptoms, sick contacts. She has no history of C. difficile, no recent antibiotics, no recent spoiled foods, no recent travel, no history of radiation. She does have a history of GERD and has had gastritis with mild gastrointestinal bleeding in the past and undergone EGD negative for H. pylori infection. She also has undergone colonoscopies with polyps that have been removed and reported as tubular adenomas. As her hospitalization progressed, she was diagnosed with Severe Sepsis due to E. Coli bacteremia in setting of liver abscess, Cholelithiasis without acute cholecystitis, Atrial Fibrillation with rapid ventricular response, Transaminitis (which resolved). Patient was appropriately treated for these conditions. Also, her known uncontrolled diabetes was treated. Per an Infection Disease note on 3/9/21: The patient has had hx of biliary colic (self diagnosis) now with discovery of non-obstructive cholelithiasis on RUQ US it is plausible that the abscess originated from self limiting cholecystitis/cholangitis which would be consistent with recent abdominal pain exacerbated with oral intake. Difficult to state definitively any relation to COVID-19 vaccination, though may have resulted from associated dehydration. Additional COVID vaccine info (both Pfizer): first dose: 2/7/21 lot# EN 5318 second dose: 2/28/21 lot# EN6202
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| 71 | 2021-03-24 | joint pain |
Client began complaining of feeling dizzy and was flushed and hot. 3 RNs were on scene assessing cli...
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Client began complaining of feeling dizzy and was flushed and hot. 3 RNs were on scene assessing client. Vitals were taken (180/90; 97% RA; hr 97. Client was given water and a fan was placed near pt. Client then began to complain of chest discomfort and burning in her throat like heartburn. She also began to feel nauseous. The dizziness began to get better. The client initially began to say she was feeling better, a couple minutes later she began to complain of chest pain/pressure. She described it as an elephant sitting on her chest. She also stated that her left shoulder began to hurt. She was also pale. Her vitals at this time were bp of 170/85; 02 of 97%; hr of 78. 911 was called at 4:10pm and arrived at 4:15pm. Chest pain was down to a 4 and nothing of significance was noted by EMS on the heart monitor. Client was given the option to be taken to the ER and she consented to transportation.
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| 71 | 2021-03-24 | joint pain |
severe pain in joints, wrists, elbows, ankles, hips/ ongoing headache behind eyes/nausea-joint pain ...
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severe pain in joints, wrists, elbows, ankles, hips/ ongoing headache behind eyes/nausea-joint pain wakes me from sound sleep, ongoing exhaustion, lack of appetite
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| 71 | 2021-03-26 | back pain |
On Saturday Mar. 20th, I had my 2nd dose of the Pfizer vaccine. Approximately 3:00 AM, March 21, I ...
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On Saturday Mar. 20th, I had my 2nd dose of the Pfizer vaccine. Approximately 3:00 AM, March 21, I had a very severe reaction to the vaccine causing extreme pain in my belly and lower back. (Mainly my lower right back) The pain was exactly like my kidney stone pain...so painfully intense. Although trying to manage the pain with 2X 500 mg of acetaminophen every 6 hours, I was throwing up, pacing, rocking and becoming so weary of how was I going to get through this. A fever of 101.5 started sometime on Sunday and fluctuated but was no higher than 101.7. A heating pad helped to ease the pain and I was able to get some sleep until the flare up would start all over again. This continued throughout the day for 17 hours. By Monday , March 22, morning the intense pain was gone and my body was recouping. My stomach was achey from either the intense pain or the vomiting. I continured to run a fever of 101. until Tuesday afternoon, March 23.
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| 71 | 2021-03-27 | neck pain, back pain |
About 13 hours post-vaccination, extreme chills, shivering, body aches and headache commenced. I ra...
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About 13 hours post-vaccination, extreme chills, shivering, body aches and headache commenced. I ran a temperature of 101 degrees for about 24 hours. The headaches/neck aches were so extreme that no food, noise, or light could be tolerated. Hot pads were applied. Only sips of water were tolerated for the first 48 hours. After 24 hours additional pain occurred in lower back and right hand knuckles (sites of previous injuries). Headaches occurred from the sides, radiating up from neck to top of head, and behind eyes at various times, dulled slightly by ibuprofen. On day three small amounts of simple food were tolerated, Ibuprofen was continued. At about 72 hours post-vaccination, all symptoms disappeared, as if there were an "off" switch.
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| 71 | 2021-03-28 | joint pain |
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at In...
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Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium
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| 71 | 2021-03-29 | joint pain |
all of my joints hurt, chills, extreme fatigue. Shot on thursday, symptoms still present on tuesday...
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all of my joints hurt, chills, extreme fatigue. Shot on thursday, symptoms still present on tuesday. Like when I was in chemo. able to move around slowly and for short periods. I am sure this will go away, but it has taken several days already.
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| 71 | 2021-03-30 | joint pain |
fatigue, body aches, joint pain, severe migraine, followed 5 hrs later by nausea, vomiting, diarrhe...
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fatigue, body aches, joint pain, severe migraine, followed 5 hrs later by nausea, vomiting, diarrhea lasting 12 hrs. nausea and fatigue lasted a total of 4 1/2 days.
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| 71 | 2021-03-30 | joint pain |
Eye floaters/ doesn't have eye floaters before but now she does/ now she sees it more and it is pret...
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Eye floaters/ doesn't have eye floaters before but now she does/ now she sees it more and it is pretty much every day; Eye floaters/ doesn't have eye floaters before but now she does/ now she sees it more and it is pretty much every day; did the CRP and it was elevated. C reactive protein- elevated; small bruises; Itching; Difficulty chewing; Joint pain; having difficulty walking; Dry skin; This is a spontaneous report from a contactable physician. A 71-year-old female patient received second dose of bnt162b2 (BNT162B2; batch/Lot Number: EN5318; expiration date not provided), intramuscular on 05Feb2021 as SINGLE DOSE for COVID-19 immunisation. Patient's medical history included ongoing 'Diabetes/High sugar/ Diabetes', lymphoma (reported as in remission now) from 2010 and ongoing, 'General wellbeing' from an unspecified date and unknown if ongoing; eye floaters from an unspecified date and ongoing. Concomitant medications included glipizide from Jan2021 and ongoing for 'High sugar'; metformin from an unspecified date (taking for a long time) and ongoing for 'High sugar/ Diabetes', colecalciferol (VITAMIN D [COLECALCIFEROL]) from an unspecified date (taking for a long time) and ongoing; calcium from an unspecified date (taking for a long time) and ongoing; and cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) from an unspecified date (taking for a long time) and ongoing for 'General wellbeing'. Patient previously took bnt162b2 (BNT162B2; batch/Lot Number: EL1283; expiration date not provided) on 17Jan2021 for COVID-19 immunisation. The patient experienced joint pain and 'having difficulty walking' (both serious, disabling) and dry skin (medically significant) on 19Feb2021; itching, difficulty chewing, and small bruises (all serious, medically significant) on Mar2021; eye floaters on an unspecified date; and 'did the CRP and it was elevated/C reactive protein- elevated' (non-serious) on 08Mar2021. Patient's clinical course is as follows: a physician reporting on behalf of his wife (patient). It was reported that patient received both doses of the COVID-19 vaccine. Reporter stated that they have side effects to report and wanted to find out how common these side effects are and how long they are going to last. Patient received first dose on 17Jan2021 and second on 05Feb2021. It was reported that the patient has been having joint pain starting from 19Feb2021 and it fluctuates from one joint to another so if the patient's shoulder is affected, the joint pain goes to the other side and then to a different joint such as her knee joint. The pain was continuous, and it doesn't disappear. Reporter mentioned that it gets better with medication but it's still not going away. Regarding patient's treatment, it was reported that in the beginning, patient was taking ibuprofen but now the doctor switched it to naproxen (ALEVE) and also added hydrocodone bitartrate and acetaminophen (NORCO). Reporter mentioned that sometimes not only the patient's joints gets affected, patient also experienced difficulty chewing, but it goes away and then comes back. Patient also had dry skin, itching, and sees eye floaters sometimes. Initially, reporter mentioned that patient doesn't have eye floaters before but now she does, then clarified she has seen it before the vaccine, but now she sees it more and it is pretty much every day. Patient also had small bruises. Reporter just wanted to know if someone can tell him if it's related to vaccine and how long this might last. Seriousness criteria for joint was reported that this is disabling as the patient was having difficulty walking, getting up from the bed from the chair, patient has to use a walker to walk and needs help going to bathroom and taking a shower. It was reported that joint pain has definitely affected patient's normal walking. Reporter also mentioned that he was not exactly sure when the dry skin started but it was around the time the joint pain started. Seriousness criteria for dry skin and itching was reported as medically significant because it does bother the patient. Patient was scratching even in her sleep, even though they use the moisturizer and cream. Reporter clarified it was not debilitating but it does bother the patient. Reporter mentioned that difficulty chewing started over the last few days, on Friday or Saturday. It comes and goes, one day patient might have it in the afternoon, but it goes away in the evening. Reporter added that the eye floaters started more in the last one week. They do not know why this is happening, if it was vaccine related or not. The medicines the patient takes shouldn't be causing these, but they don't know if it was the medicine causing it or if it's the vaccine. Causality for was reported as 'didn't have these issues before, thinks it's related, this is for all the events'. It was further reported that the doctor did the CRP and it was elevated also reported as C reactive protein- elevated on Monday 08Mar2021. Outcome of the events 'small bruises' and 'did the CRP and it was elevated. C reactive protein- elevated' was unknown; outcome of the remaining events was not recovered.; Sender's Comments: Based on temporal association and known drug profile, a contributory role of bnt162b2 to the reported events cannot be totally excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 71 | 2021-04-01 | muscular weakness, muscle pain |
Massive headaches, overall muscle aches, weakness in left arm, minor nausea, loss of appetite. Disru...
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Massive headaches, overall muscle aches, weakness in left arm, minor nausea, loss of appetite. Disruption to INR.
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| 71 | 2021-04-01 | musculoskeletal stiffness, neck pain |
Fever; Headache; Redness; Stiffness; Bruising; Neck pain; pain Swelling/Throbbing; pain Swelling; Th...
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Fever; Headache; Redness; Stiffness; Bruising; Neck pain; pain Swelling/Throbbing; pain Swelling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER; Solution for injection; Lot number: EL3302, COVID 19) administered in left arm via an unspecified route of administration on 25Feb2021 at 11:30 AM at single dose for COVID-19 immunization. Medical history included Sarcoma cancer (amputated hand), heart failure, patient was allergic to Morphine, nitroglycerin, pertussis, walnuts, corn and bees. Concomitant medications were not reported. On 04Feb2021 at 12:30 PM, patient received first dose of BNT162B2 (PFIZER; Solution for injection; Lot number: EL0142) administered in left arm for covid-19 immunization. No other vaccine was given in four weeks. It was reported that patient was given other medications in two weeks: 15 meds too many to list. On 25Feb2021 at 22:00, patient experienced fever, headache, redness, stiffness, bruising, neck pain, pain swelling and throbbing which resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The patient received treatment with Meloxicam for 10 days for the events. The patient not had covid prior to vaccination. The patient not tested for covid post vaccination. The outcome of all events was reported as not recovered.
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| 71 | 2021-04-01 | muscle pain |
Went to bed on fourth night after shot with symptoms from shot seemingly resolved. Woke up the fif...
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Went to bed on fourth night after shot with symptoms from shot seemingly resolved. Woke up the fifth day and got out of bed to discover intense pain in right leg. Nothing like a charley horse cramp. Small nodule about the size of a pea, located 6 inches up from outside ankle bone. ¼ inch beneath skin. Great difficultly putting weight on right leg, created acute feeling of pinching or twisting pain. Level of pain (1-10) was an eight [note: my definition of the ?worst pain imaginable? has been altered after being stung by a tarantula hawk wasp]. I hobbled to the bathroom and took two aspirin. Hobbling around on flat surfaces gradually reduced pain to a level 3-4, though I had trouble walking up and down steps for the remainder of the day (level 5-6). Fifth day, the pain level on flat surfaces was down to 1-2, on stairs, 2-3. at end of sixth day, no pain on flat surfaces, 1-2 on stairs. No pain by evening. I took two aspirin in morning and two in afternoon during this period. Seventh day, I woke up to find pain returned as I got out of bed (level 4) but was walked out within in three to four hours. I had talked with my sister (an extreme case of Factor five leiden, which I do not have) and felt this was not a blood clot, but went in to the doctor?s because my husband and I were about to leave on vacation. She ordered a Doppler and ultrasound (which showed no blood clot) after telling me this type of muscle/nerve pain was just starting to be reported in patients after the vaccine. She had seen an earlier patient who had swelling and inflammation, which showed no other explanation after testing than post-vaccination reaction. I felt no lump, heat, or tenderness pushing on the skin. Doctor requested I report it on-line.
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| 71 | 2021-04-02 | neck pain, muscular weakness |
Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and tur...
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Palms of hands itched tremendously and turned bright red; Palms of hands itched tremendously and turned bright red; chest congestion with coughing; chest congestion with coughing; Brain fog; fatigue; muscle weakness; nausea; slight diarrhea; Extremely sore arm up into neck; Extremely sore arm up into neck; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via an unspecified route of administration in the left arm on 15Feb2021 11:00 at a single dose for COVID-19 immunization. Medical history included arthritis and patient was 17 years post endometrial, ovarian cancer, stage 1; she had no known allergies. Concomitant medication included ibuprofen (ADVIL) taken for arthritis. The patient did not have COVID prior vaccination, had no other vaccines in four weeks and was not pregnant. She received the vaccine at a Public Health Clinic. On 15Feb2021 11:45, the patient experienced chest congestion with coughing lasting 45 minutes, brain fog, fatigue, muscle weakness, nausea, slight diarrhea and extremely sore arm up into neck. Twice after the first dose; first onset was 45 minutes after first injection. She also experienced palms of hands itched tremendously and turned bright red, lasting 20-25 minutes. Three days after first dose (18Feb2021). The day of the first injection plus three days after, something happened every day. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6205), via an unspecified dose in left arm on 11Mar2021 11:00 at a single dose for COVID-19 immunization. The patient has not been tested for COVID post-vaccination. Outcome of the events chest congestion with coughing was recovered on 15Feb2021 12:30, palms of hands itched tremendously and turned bright red was recovered on 18Feb2021 and of the remaining events was recovering.
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| 71 | 2021-04-03 | joint pain |
Headache; body and joint aches; body and joint aches; chills; extrem tiredness; This is a spontaneou...
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Headache; body and joint aches; body and joint aches; chills; extrem tiredness; This is a spontaneous report from a contactable consumer or other non hcp. A 71-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot #;FL9265), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 10:00 as SINGLE DOSE for covid-19 immunisation. Medical history included cardiac disorder from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing, covid-19 from an unknown date and unknown if ongoing. Concomitant medication included pramipexole dihydrochloride (PRAMIPEXOLE DIHYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported; ezetimibe (EZETIBE) taken for an unspecified indication, start and stop date were not reported; clopidogrel (CLOPIDOGREL) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced headache, body and joint aches, chills, extrem tiredness. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was recovering.
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| 71 | 2021-04-06 | joint pain |
every joint in her was so painful, she couldn't sleep, rollover, or walk. She said she had a lot of ...
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every joint in her was so painful, she couldn't sleep, rollover, or walk. She said she had a lot of pain in every joint of her body; neck, feet, ankles, and everything; every joint in her was so painful, she couldn't sleep, rollover, or walk. She said she had a lot of pain in every joint of her body; neck, feet, ankles, and everything; every joint in her was so painful, she couldn't sleep, rollover, or walk. She said she had a lot of pain in every joint of her body; neck, feet, ankles, and everything; get sick; injection site irritation; wheezy; This is a spontaneous report from a contactable other HCP. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot Number: EN6198) via an unspecified route of administration, administered in Arm Left on 01Mar2021 as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, diabetes mellitus, cardiac pacemaker insertion from Dec2020 and ongoing, ongoing asthma and covid-19 from Mar2020. The patient's concomitant medications were not reported. On 02Mar2021, the patient stated that every joint in her was so painful, she couldn't sleep, rollover, or walk. she said she had a lot of pain in every joint of her body; neck, feet, ankles, and everything. The patient also had wheezy on Mar2021, get sick on 02Mar2021 and injection site irritation on 01Mar2021. The events joint pain, insomnia and gait disturbances were assessed as disability by the reporter. Outcome of the events insomnia, joint pain and gait disturbances were recovering while outcome of the remaining events was recovered on an unspecified date.; Sender's Comments: The information currently provided is very limited hence the causal association between the suspect drug and reported events arthralgia, insomnia and gait disturbance cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 71 | 2021-04-12 | weight decreased |
she has lost 2 lbs since she started with all this.; get tested and got her results back early on Mo...
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she has lost 2 lbs since she started with all this.; get tested and got her results back early on Monday and it was positive; This is a spontaneous report from a contactable consumer. A 71-year-old female consumer (patient) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809), via an unspecified route of administration on 13Feb2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had the first Pfizer shot on 13Feb 2021, soon after shot patient had chills but ignored it most of the time until Sunday and tested again and resulted as positive. They are scheduled to have the second on 06Mar2021. Both her husband and herself got the shot on 13Feb2021. On an unspecified date, the patient lost 2 lbs since she started with all this. On 21Feb2021, the patient underwent lab test and procedure which include tested Covid test and resulted positive. The patient assessed the events as non-serious. The outcome of the events were unknown. No follow up attempts are possible. No further information is expected.
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| 71 | 2021-04-14 | joint pain |
Death R05 - Cough J96.90 - Respiratory failure R55 - Syncope R41.82 - Altered mental status I95.9 -...
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Death R05 - Cough J96.90 - Respiratory failure R55 - Syncope R41.82 - Altered mental status I95.9 - Hypotension M25.551 - Right hip pain Z79.01 - On apixaban therapy
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| 71 | 2021-04-20 | joint pain |
4/14-Resident c/o not feeling well and declined scheduled dialysis. c/o bilateral shoulder pain and...
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4/14-Resident c/o not feeling well and declined scheduled dialysis. c/o bilateral shoulder pain and fatigue. AP- 44, BP- 80/45, c/o headache, no chest pain and no SOB. Sent to CMC ER- patient deceased on 4/14/2021.
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| 71 | 2021-04-21 | back pain, joint pain |
pain in right arm and back into the right shoulder blade> increased through out the follow week deve...
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pain in right arm and back into the right shoulder blade> increased through out the follow week developing around day 10 into not being able to rise the right arm without pain. Symptoms increased into fatigue, flu like systemic reactions of whole body agitated, over stimulated electric like quality. Mental agitation. Started using Tylenol every 6 hours for pain. Started icing arm. Emotionally draining. 4/21/21 arm started not to be painful for lifting. Very emotional. Systemic agitation starting to calm down on the 22nd of April.
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| 71 | 2021-04-21 | back pain |
Patient reports she started to have RT arm and shoulder pain after the injection, which was expected...
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Patient reports she started to have RT arm and shoulder pain after the injection, which was expected side effect, so patient did not report to the clinic. However, the pain did not go away over 3 weeks and it started to spread to RT upper back and shoulder and patient also started to feel numb in the area. Patient came to the clinic on 04/22/2021, reporting this is about 1 month and problem persists. Patient is referred out to nuerologist visit, and is prescribed for gabapentin 100mg BID. Will follow up in 2 weeks again.
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| 71 | 2021-04-22 | rheumatoid arthritis, joint swelling |
1/19/2021 - pain, tingling, numbness in hand, referral for MRI and neurological exam 2/08/2021 - inc...
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1/19/2021 - pain, tingling, numbness in hand, referral for MRI and neurological exam 2/08/2021 - increased pain, tingling and numbness in hands, Neurological exam and MRI review 3/04/2021 - significant pain, swelling, tenderness, warmth in hands, shoulders, arms, feet, legs, ankles; inability to grip, lift, raise arm 3/5 to 3/18/2021 - Increase in all symptoms 3/18/2021- Decrease in all symptoms with prednisone and methotrexate
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| 71 | 2021-04-23 | back pain |
I woke up feeling a little nauseated; My back ached slightly; chills; had a fever of 100.8; This is ...
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I woke up feeling a little nauseated; My back ached slightly; chills; had a fever of 100.8; This is a spontaneous report from a contactable Consumer (Patient). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 17Feb2021 01:30 (Batch/Lot Number: EL9267) as single dose for covid-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing (Multiple Sclerosis asymptomatic for 30 years). Concomitant medication included celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported. On 18Feb2021 07:00, the patient reported i woke up feeling a little nauseated, my back ached slightly, chills, had a fever of 100.8. I took Ibuprofin with no alleviation of symptoms. A few hours later I tried Tylenol - with no change. Later in the afternoon I took aspirin. The patient underwent lab tests and procedures which included body temperature: 100.8 on 18Feb2021 (around 100.5 at 4:00 p.m. By 6:00 pm my temp reading was 99.4.). he action taken in response to the events for BNT162B2 was not applicable. Therapeutic measures were taken as a result of had a fever of 100.8. The outcome of events was Recovering.
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| 71 | 2021-04-23 | limb discomfort, muscle pain |
Arm felt like lead and could not raise it; Stinging sensation at injection site; felt like it stung ...
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Arm felt like lead and could not raise it; Stinging sensation at injection site; felt like it stung when she received the first dose. She felt it running into her vein.; When she took the band aid off, instead of a spot, there was an area of blood; muscle pain; This is a spontaneous report from a contactable consumer (Patient) self-reported. A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247 and expiry date: unknown), Injected via an intramuscularly route of administration in left arm on 06Feb2021 at 16:15, as a single dose for COVID-19 immunization. Patient medical history included high blood pressure, diminished kidney and family history like her mother had a breast cancer and father had massive heart attack. Patient concomitant medications included as amlodipine (5mg) daily for high blood pressure start date and stop date was unspecified. Patient did not take it prior to getting the vaccine. Patient did not receive other vaccine in four weeks of vaccination. Patient did not get the adverse events prior vaccinations. Patient experienced felt like it was stung" when received the first dose. Patient could feel warm fluid running through vein on 06Feb2021, and stinging sensation at vaccination site on 06Feb2021 at 16:15 and arm felt like lead and could not raise it on 06Feb2021 at 18:00. When she took the band aid off, instead of a spot, there was an area of blood in Feb2021. And experienced muscle pain in feb2021. Patient took an extra strength Tylenol. The outcome of the event felt like it stung and felt it running into vein and Arm felt like lead and could not raise it was recovering and outcome of the event Stinging sensation at injection site, band aid off, instead of a spot and muscle pain was unknown.
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| 71 | 2021-04-23 | neck pain |
Left arm sore. Left arm painful to lift up.pain runs from left arm to left tendon in neck; Left arm ...
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Left arm sore. Left arm painful to lift up.pain runs from left arm to left tendon in neck; Left arm sore. Left arm painful to lift up.pain runs from left arm to left tendon in neck; Entire body is cold especially both feet even with two layers of clothes; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EN6198, Expiration date: Unknown) via an unspecified route of administration in arm Left on 20Feb2021 10:00 as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included thyroid Hasimotos disease and Known allergies included Morphine. The patient previously took morphine and experienced drug hypersensitivity. The patient had no other vaccine in four weeks. The patient not had COVID prior vaccination. Concomitant medication in two weeks included pravastatin (PRAVASTATIN) 20 mg, levothyroxine sodium (LEVOTHYROXIN) 50 mcg and lisinopril (LISINOPRIL) for unknown indication. On 21Feb2021 07:00, the patient experienced left arm sore, left arm painful to lift up. Pain runs from left arm to left tendon in neck and entire body is cold especially both feet even with two layers of clothes. The patient not tested COVID post vaccination. The patient did not receive any treatment for the event. The outcome of events was not recovered.
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| 71 | 2021-04-24 | joint pain |
She says her tooth was bright red; her whole cheek and still; anxious aggravated; upset; she said th...
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She says her tooth was bright red; her whole cheek and still; anxious aggravated; upset; she said this what she has, almost like a fibromyalgia; Shingles became aggravated; she had had broken toe on the other foot that was killing her; total fatigue, no energy at all; total fatigue, no energy at all; abscess on tooth that will be pulled tomorrow; She doesn't have the strength that she had before; This is a spontaneous report received from a contactable consumer (patient) reported that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EP7534, Expiration date: UNKNOWN), dose 2 via an unspecified route of administration on 11Mar2021 12:00 as SINGLE DOSE, dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EN620) as SINGLE DOSE for covid-19 immunisation. The patients medical history included ongoing asthma since she was 4 years old, ongoing herpes zoster (Shingles) since Nov2019, Raynaud's phenomenon for 20 years, High anxiety, gastroesophageal reflux disease from 4 years. Concomitant medications included amoxicillin at an unspecified dose taken for an unspecified indication for 7.5 days from 29Mar2021 to 05Apr2021; Advair Disc at an unspecified dose taken for an unspecified indication for maybe 30 years she is prescribed twice a day but takes it only once day, fluticasone propionate, salmeterol xinafoate (PROAIR BRONQUIAL) taken for an unspecified indication from an unspecified start date and ongoing; she had been on this for maybe 30 years, as needed, montelukast sodium (SINGULAIR) taken for asthma from an unspecified start date and ongoing for 30 years, multivitamin, sambucus nigra, sodium, zinc (MULTIVITAMIN, SAMBUCUS NIGRA, SODIUM, ZINC) taken for an unspecified indication from an unspecified start date and ongoing, she says she has been taking this forever because she never ate vegetables, magnesium sulfate (MAGNESIUM SULFATE) taken for bowels from an unspecified start date and ongoing from around 4-5 years as it helps with her bowels, felodipine (FELODIPINE ACTAVIS) taken for an unspecified indication from an unspecified start date and ongoing, for 30-40 years; rosuvastatin calcium (ROSUVASTATIN CALCIUM) taken for an unspecified indication from an unspecified start date and ongoing; calcium, colecalciferol (CALCIUM PLUS D3) taken for bones from an unspecified start date and ongoing for 30 years once menopause started, for bones, famotidine (FAMOTIDINE) taken for an unspecified indication from an unspecified start date and ongoing, says she has been on this for maybe 4 years because she was eating a lot of Rolaids. The patient was also taking for concomitant Products Hair, nail, skin vitamin for hair, nail, and skin health and says her nails are nice and strong, she still has wrinkles, but she says that was part of being old. The patient also said flu shot in Sep2020, pneumonia shot, shingles shot on an unspecified date and had nothing. patient says the first shot was nothing, everything was fine, the second shot she was thinking this is good, everything is good, it was on 11MAR2021 but by 14Mar2021 she was in total fatigue, started to get an abscess on tooth, she doesn't think this was because of shot, she has a prostheses, fake hip, her hip was killing her where the actual bone joint was, she had had broken toe on the other foot, that was killing her, she had no energy at all. She says normally, she is 71 years old, she was very active. She says her doctor takes care of everything, in her case she is asthmatic, everything, he does all of her bloodwork. she has to get this tooth pulled, she had some cadaver teeth put in, she went to the gym, everything was great, all the sudden she has an abscess, she went to her periodontist who says it is bad, it needs to be pulled. She says she was going to get her tooth pulled tomorrow. She reports her shingles seemed to get aggravated, her doctor said she will always have this, when she gets upset, aggravated or anxious it flares up, she is now back on the gabapentin, it is like pins and needles under rib cage where the actual shingles were. She says she was asthmatic but it did not bother her lungs one bit, she did not have any lung issues. She says everything happened on 14MAR2021. She reports that she does find she gets tired, she cooked all day Saturday, she stood over the stove all day, she did nothing but that all day. She says her tooth was bright red, her whole cheek and still, she took the last antibiotics, a heavy dose, last dose this morning too. She reports her foot is not bothering her anymore, her hip is still a little sore. She says she can do 2 miles in the gym, it was hard to exercise with mask on, it is always cold, she can't walk, she's limited to what she can do right now. she said this what she has, almost like a fibromyalgia, she diagnosed herself as having this condition, she Googles it and it says its muscle pain, she doesn't have the strength that she had before, she doesn't have hand strength, stamina, to walk a mile killed her, now she can do 2 miles, she is not 100% of what she was, she's coming along though. prior Vaccinations (within 4 weeks); she got her flu shot in SEP2020; AE(s) following prior vaccinations: She says flu shot, pneumonia shot, shingles shot, and had nothing. The patient was recovering from fatigue and asthenia, not recovered from tooth abscess and shingles and rets of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 71 | 2021-04-28 | muscular weakness, joint pain, neck pain, muscle pain, back pain |
muscle pain; back pain; fever; felt panicky; neck pain; runny nose; Stinging pain in left leg / pain...
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muscle pain; back pain; fever; felt panicky; neck pain; runny nose; Stinging pain in left leg / pain in left arm; pain in the joints; Red circle around injection site; Weak feeling in arms and legs; body feels heavy; dizziness; Very exhausted; Nausea; Diarrhea; Some cramping in stomach; Brain Fog; Body aches; headache; itchiness; Left arm sore at injection site; anxiety; not feeling well; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 28Feb2021 at 15:00 (at the age of 71-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes diagnosed 15 years ago, obesity, asthma with bronchitis as a child, allergy to other medications, anaphylactic reaction to sulfas twenty years ago (also reported as 50 years ago), muscle hurt/sore arm usually when she got a flu vaccine (unspecified) once a year, allergies to makeup and clothes (diagnosed at least 50 years ago), heart beats fast, low thyroid and borderline high cholesterol. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for 30 years for low thyroid, nebivolol hydrochloride (BYSTOLIC) taken for 25 years, rosuvastatin calcium, (CRESTOR OD) taken for 2 years for borderline high cholesterol and insulin (unspecified). The patient did not receive any other vaccinations on the same day or within 4 weeks of the vaccine. The patient previously took paracetamol (TYLENOL) and diphenhydramine (BENADRYL) as pre-medication since she had allergic reactions to some things and would get this before the flu shot; as well as salbutamol sulfate (PROAIR HFA) for runny nose and coughing. The patient had the first dose of the vaccine on 28Feb2021, and "they" wanted to give her diphenhydramine (BENADRYL) after the vaccine but could not since she was driving. After the vaccination, the patient was not feeling well for 2 days (as of an unspecified date) and thought she was getting better. On 28Feb2021, the patient experienced anxiety. She was more anxious when "that stuff" appeared on the news on day 4 and 5 after the vaccine. She took a small dose of clonazepam 0.5 mg, dividing the pill in 4 pieces as she never took the whole thing. She took it when she got extremely anxious and tried not to take it because it can be habit forming. She may take it 3 times a week or in the middle of the night. It helped a little bit, but she still felt panicky and upset. She woke up feeling anxious. She did not normally take these medications. The patient reported that she experienced headache (constantly several times a week) and left arm sore at injection site, itchiness/ itching all over body (not constant but still happening) from 28Feb2021. On Mar2021 (day 4), the patient experienced dizziness (comes and goes and was not constant like it was), was very exhausted, nausea (tapered off after 2 weeks), diarrhea, some cramping in stomach, brain fog (still struggling and forgets to take her insulin, not as bad as when she first noticed), body aches. At first, the body aches were a pain in the left knee and left elbow and then moved to various joints and muscles. The left knee and elbow pain persisted without ever going away, but also moved to different areas. The calf muscle in left leg pain is also constant. The patient experienced pain in the joints and stinging pain in left leg (below knee down to ankle) from 04Mar2021, runny nose (tapered off) from 07Mar2021, and on an unspecified date muscle pain, back pain, fever, neck pain, pain in left arm. On Mar2021 (two weeks after vaccination), the patient had a red circle around injection site not all the way filled in, but rim around where she got shot. On Mar2021 (3 weeks after vaccination), the patient experienced a weak feeling in arms and legs and other times when she stood up her body felt heavy (persistent but not every day). The patient spoke with her physician who did not believe the patient about the symptoms and recommended she seek psychiatric help. The patient had not received the second dose of the vaccine because her physician did not recommend it. She was upset because her physician told her she could not get the second shot. She was having worsening anxiety because she had not been feeling well for so long, going on 7 weeks. She visited her physician's office 6,7, or 8 times. The patient underwent lab tests and procedures on unspecified dates which included an ultrasound of the leg (did not have a blood clot), an X-Ray of the back (unknown results) and an MRI of the back (did not find anything) to determine the pain. The physician thought it might be a compression fracture, but the MRI did not show anything. The patient was tested for antibodies on 05Apr2021 and had zero antibodies. The clinical outcome of anxiety, felt panicky, neck pain was unknown; dizziness, headache, runny nose, itchiness, pain in the joints, muscle pain, back pain, fever, very exhausted, nausea, diarrhea, some cramping in stomach, brain fog, body aches, stinging pain in left leg / pain in left arm, weak feelings in arms and legs, body feels heavy, left arm sore at injection site, red circle around injection site, not feeling well, was resolving. No follow-up attempts are needed. Information on lot/batch cannot be obtained.; Sender's Comments: Linked Report(s): same patient, different vaccine dose/event
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| 71 | 2021-05-04 | muscle pain |
Extremely tired; Sore arm; 2nd shot-muscle pain; This is a spontaneous report from a contactable con...
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Extremely tired; Sore arm; 2nd shot-muscle pain; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in the right deltoid on 18Feb2021 (Batch/Lot Number: ENb298) as a single dose for COVID-19 immunization. Medical history included diabetes-onset date: years, stroke on 12Feb2002, breast cancer in Dec2015 and cholesterol, headaches, restless legs. Concomitant medications included rosuvastatin calcium (ROSUVASTATIN CALCIUM GENERIC) taken for cholesterol from an unspecified start date and ongoing; tocopherol, ubidecarenone (COQ-10 ST) taken for cholesterol from an unspecified start date and ongoing; gabapentin enacarbil (HORIZANT) taken for headaches, restless legs from an unspecified start date and ongoing; anastrozole (ANASTROZOLE) taken for an unspecified indication from an unspecified start date and ongoing; empagliflozin (EMPAGLIFLOZIN) taken for an unspecified indication from an unspecified start date and ongoing; eicosapentaenoic acid ethyl ester (VASCEPA) taken for an unspecified indication from an unspecified start date and ongoing; denosumab (PROLIA) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, first dose, lot number: EL1298) on 28Jan2021 for COVID-19 immunization and experienced blood pressure systolic high and dizziness. The patient felt extremely tired on an unspecified date and was hospitalized for about a week (7 days), had a sore arm on an unspecified date and was hospitalized for 2 days and experienced muscle pain on an unspecified date. No treatment was administered for the event extremely tired, for the muscular pain Tylenol was taken starting 24 hours after shot - stayed in shot area. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
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| 71 | 2021-05-10 | muscular weakness |
H/o meningioma and left ICA occlusion w/ prior traumatic ICH sent from outpt clinic s/p 2nd covid va...
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H/o meningioma and left ICA occlusion w/ prior traumatic ICH sent from outpt clinic s/p 2nd covid vaccine with acute onset slurred speech, facial asymmetry and LUE weakness (?chronic), atraumatic, nml AC, pt HD stable, stroke alert on arrival, symptoms improving
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| 71 | 2021-05-13 | muscular weakness |
After first shot began experiencing weakness in legs; fell several times; This is a spontaneous repo...
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After first shot began experiencing weakness in legs; fell several times; This is a spontaneous report received from a contactable consumer (the patient). This is the first of 2 reports. A 71-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9262) via an unspecified route of administration in left arm on 30Jan2021 at age of 71-year-old at single dose for COVID-19 immunisation. Relevant medical history included COVID-19 from Nov2020 (Was in hospital with COVID in November. Did well in December and January). Other medical history reported as "none". No known allergies. Concomitant medications (received within 2 weeks of vaccination) included bupropion taken for an unspecified indication from an unspecified date; clonazepam taken for an unspecified indication from an unspecified date and "Celebs" (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. After first shot began experiencing weakness in legs and fell several times. The events onset date was 01Feb2021. "Steroids" was received for the event "weakness in legs". CT scans of entire spine and brain with unknown result. The events resulted in Doctor or other healthcare professional office/clinic visit, Hospitalization (for 23 days), Disability or permanent damage. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) :PFIZER INC-2021531421 same patient/reporter/drug, different AE in separated time
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| 71 | 2021-05-13 | muscular weakness |
leg weakness became worse; This is a spontaneous report received from a contactable consumer. This i...
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leg weakness became worse; This is a spontaneous report received from a contactable consumer. This is the second of 2 reports. A 71-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6201) via an unspecified route of administration in right arm on 19Feb2021 at age of 71-year-old at single dose for COVID-19 immunisation. Relevant medical history included COVID-19 from Nov2020 (Was in hospital with COVID in November. Did well in December and January). Other medical history reported as "none". No known allergies. Concomitant medications (received within 2 weeks of vaccination) included bupropion taken for an unspecified indication from an unspecified date; clonazepam taken for an unspecified indication from an unspecified date and "Celebs" (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9262) via an unspecified route of administration in left arm on 30Jan2021 at age of 71-year-old at single dose for COVID-19 immunisation and experienced "after first shot began experiencing weakness in legs" and "fell several times" on 01Feb2021. It reported after second shot leg weakness became worse. The event onset date after second shot was not reported. "Steroids" was considered as treatment for the event. CT scans of entire spine and brain with unknown result. The event resulted in Doctor or other healthcare professional office/clinic visit, Hospitalization (for 23 days), Disability or permanent damage. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021476453 same patient/reporter/drug, different AE in separated time
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| 72 | 2021-01-04 | muscular weakness |
arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she coul...
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arms hurting; Lymph nodes hurting on the left side; chills in which she is hot and cold and she couldn't get warm at first and then she is cold; high blood pressure/blood pressure was high 190/116; big toes hurting; nausea; dizziness; feeling weakness legs/Leg feeling weak; This is a spontaneous report from a contactable other HCP reporting for herself. A 72-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: CJ1686), via an unspecified route of administration in the right arm on 28Dec2020 15:00 at single dose for COVID-19 immunisation. Medical history included breast cancer on the left side, hypertension, hiatal hernia, glaucoma, heart disease, hypertension, lymphadenectomy (lymph nodes being taken out was about 20 years before) and headache from 27Dec2020. She was working Sunday into Monday morning and she went to the Director of Nursing, and said she has a Headache on the left side of the temple, and so she went to eye doctor, and he had a test order ESR and so she has a hemorrhage in the left eye, and show she doesn't know if this could be bringing on some of the side effects she was speaking about, like the nausea and the migraine. She has had No positive test for COVID prior to the vaccine, she must have had about 20 tests and all were negative. She has not had any Antibody tests. She had pneumonia vaccine maybe in the last 5-3 years and flu vaccine in Oct2020 and she experienced achy arm. On 28Dec2020 the patient experienced leg feeling weak (about 15 minutes after injection), nauseous at 21:00, dizziness. On 29Dec2020 the patient experienced arm hurting (in the morning), lymph nodes hurting on the left side, chills, blood pressure was high 190/116, big toes hurting. The patient was calling to ask if these side effects she was experiencing were normal. On 29Dec2020 the patient underwent ESR with unknown results. The patient reported that her arm hurting began on 29Dec2020 in the morning. The breast cancer diagnosis was prior to the vaccine as well as her lymph nodes being taken out was about 20 years ago. Her Lymph nodes hurting on the left side started on 29Dec2020 in the morning. Her Leg feeling weak started right after the injection, about 15 minutes after on 28Dec2020. The chills started on 29Dec2020 in the morning in which she couldn't get warm. Her feeling nauseous started on 28Dec2020 in the evening like 9 PM. The Temperature 98.1 was her current temperature taken right before the call, as well as her blood pressure. Her feeling dizzy started after getting vaccine on 28Dec2020, she was fine to drive home, but then again on 29Dec2020 in the morning she felt it also. Her legs felt funny like rubbery. The big toes hurting started an hour before, on 29Dec2020 it woke her up since it was jabbing. The outcome of the events was unknown.
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| 72 | 2021-01-06 | musculoskeletal stiffness |
extremely stiff neck for 4 days; itching on back and shoulder area for 2-3 days, swelling of the eye...
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extremely stiff neck for 4 days; itching on back and shoulder area for 2-3 days, swelling of the eyes for 2-3 days; itchy rash on medial aspect of vaccinated arm for 2-3 days
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| 72 | 2021-01-13 | spinal pain, limb discomfort |
Injection site pain; the arm felt heavy; Aches and pains/the pain extended from her shoulder down to...
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Injection site pain; the arm felt heavy; Aches and pains/the pain extended from her shoulder down to her elbow; aches and pains/pain went from the injection shoulder and spread to the middle of her spine; aches and pains/pain went from the injection shoulder and spread to the middle of her spine; Nausea; total loss of appetite; stated that she gained 10lbs, but she is very physically active.; either not making blood or there was an interference; she was freezing/she woke up cold and could not get warm/ felt cold; she had a little headache; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, Expiry Date: Mar2021), intramuscular at left arm on 31Dec2020 at single dose for covid-19 prophylaxis. Medical history included low sodium, Covid-19 in Nov2020 (She had felt sick for a week and on 13Nov2020 she went to the ER and they did blood tests and she could not eat or drink for 3 days. She stated that she had 4 different IV fluids going and one of them was sodium and the other was for nausea), blood did not clot properly, broke her back. There were no concomitant medications.The patient had a unique reaction after receiving the Covid-19mRNA Vaccine. She clarified that she never had a reaction to a shot before. She received the vaccine on 31Dec2020 and was fine for the first 20 hours. She said that the next morning on 01Jan2021 at 0600 she woke up cold and could not get warm. She said that she spent the next 24 hours to where she kept adding clothes and blankets to keep warm. She stated that she was freezing and the she felt like the interior of her body was freezing even down to her toes felt cold. She also had injection site pain and the arm felt heavy and stated that the pain extended from her shoulder down to her elbow. She stated that the injection site pain was kind of delayed. She had aches and pains. She said that some of the pain went from the injection shoulder and spread to the middle of her spine. She had nausea and total loss of appetite and could not even eat. Her aches and pains after the vaccine were similar aches like she had with the Covid. She said that she had a terrible headache when she had Covid though. She stated that after the 24 hours of receiving the vaccine she had a little headache, but she took a migraine pill for it. She said that she was able to shed clothes, but she could not take a shower, but within 24-36 hours she was back to normal like it all never happened. She said that was when she figured out it was like her hemorrhaging with one of her childbirths. She explained that she had 3 children and hemorrhaged with each of her child births and was going into shock with one of them and felt this freezing sensation due to blood loss. She thought that her reaction to the vaccine was so bad that she was either not making blood or there was an interference. There was some kind of weird interruption. She said that her blood clots break down from minutes to hours after her child birth or with dental procedures. She had a PAI-1 deficiency or Plasminogen Activator Inhibitor-1 deficiency. She said that there was also something deeper that her doctors had not figured out yet too. She said that her blood did not clot properly. She said that she did not bruise or anything, but she was not allowed to have internal surgery without a transfusion. She said that her doctor's started to figure this all out after she broke her back before. She went to a hematologist and had her counts checked regularly. She said that she was being studied by 127 different clinics. She gained 10lbs, but she was very physically active. This was her first dose of teh vaccine. She said that her doctors told her that she needs to be under 48 hours of observation if she gets the second vaccine. Her primary care physician recommended that she did not take another mRNA vaccine. She said that she was taking their advice and canceled her second dose appointment. She said that when she had Covid-19 they did a Chest x-ray on 13Nov2020 and she had low sodium. She said that they gave her tramadol at the hospital for her headache, but she had already taken 3 migraine pills that day. She had already had her flu shot and read somewhere on a website, that mRNA vaccines might cause unstable anticoagulation. She wondered if it could be possible that Covid-19 antibodies interfered with her injection? The outcome of events was unknown.
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| 72 | 2021-01-14 | muscle pain |
The text phone contacts to me have not worked for past two days. My symptoms now are fatigue, genera...
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The text phone contacts to me have not worked for past two days. My symptoms now are fatigue, general achy joints and muscles, slight swelling and pain at the injection site. I am fine but need help with the survey sent via text does not work. Unable to "Do your weekly post-vaccination check in".
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| 72 | 2021-01-18 | joint pain, muscle pain | Low grade fever, chills, joint and muscle pain. |
| 72 | 2021-01-18 | joint pain |
joint pain persisted; confusion; anorexia; chills began 19 hours after injection; low-grade fever (1...
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joint pain persisted; confusion; anorexia; chills began 19 hours after injection; low-grade fever (100.6); hypotension; hypoglycemia; lethargy; the 2nd dose on 08Jan2021 /1st dose on 20Dec2020; This is a spontaneous report from a contactable Physician (patient). This 72-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 08Jan2021 05:00 PM at single dose (lot number: EK9231) for covid-19 immunisation. Medical history included diabetes, idiopathic encapsulating peritonitis and known allergies to Latex. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), tamoxifen, apixaban (ELIQUIS), simvastatin. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) at left arm on 20Dec2020 01:00 PM for covid-19 immunisation. The patient experienced chills began 19 hours after injection, followed by low-grade fever (100.6), hypotension, hypoglycemia, lethargy, confusion and anorexia on 09Jan2021 12: 00 PM. Illness lasted 17 hours, treated with fluids, anti- inflammatories and sleep. Some new joint pain persisted. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event joint pain persisted was unknown. Outcome of other events was recovered/resolved with sequel.
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| 72 | 2021-01-19 | muscle pain |
Patient seated in observation area after vaccination at 1412. At 1422 patient reported feeling heavi...
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Patient seated in observation area after vaccination at 1412. At 1422 patient reported feeling heaviness in chest rated at 7/10 pain scale, mandibular pain, appeared diaphoretic and fatigued, skin grey/pale, though remained alert and responsive to questions appropriately. Patient also communicates she was having some chest pain prior to the immunization today, though she indicated on her forms that she was feeling well today. Vital signs assessed, P72 R16 O2 99, patient denied difficulty breathing. Rapid response protocol initiated, applied 2L O2 via NC, transferred patient to wheelchair and taken to ED for evaluation by response team. ED assessment reveals calf tenderness and patient reporting TKA x 2 weeks ago, elevated D-Dimer, CT results pending at this time.
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| 72 | 2021-01-24 | joint pain |
leg aches, chills, joint pain, malaise started on 3rd day after injection. Today is day 8 after inj...
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leg aches, chills, joint pain, malaise started on 3rd day after injection. Today is day 8 after injection & still have malaise and nausea. Had headache yesterday and day before. Also woke up at 3AM yesterday and day before in a cold sweat. Some leg ache today as well. Have been taking 2 extra strength Tylenol every 6 hrs which sometimes gives relief but not always.
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| 72 | 2021-01-24 | muscle pain | Injection site pain, tiredness, muscle ache, chills, fever 100.1 |
| 72 | 2021-01-25 | back pain, musculoskeletal pain |
her brain is going blank; back pain that occurs in her left leg past the knee until the top of her f...
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her brain is going blank; back pain that occurs in her left leg past the knee until the top of her foot; back pain that occurs in her left leg past the knee until the top of her foot; She wanted to know if it is like a sciatic nerve pain she is experiencing; she just thought it was swelling in her spine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot no: EK9231, via an unspecified route of administration in left shoulder on 11Jan2021 at a single dose for covid-19 immunization. Medical history included other problems before taking the COVID-19 vaccine such as joint pain, muscle pain, back pain, spinal stenosis, has a lot of back issues, like sciatic has a lot of problems. There were no concomitant medications. The patient had the COVID-19 vaccine on Monday (11Jan2021). On Tuesday (12Jan2021), she experienced back pain that occurs in her left leg past the knee until the top of her foot. She also mentioned that she had other problems before taking the COVID-19 vaccine such as joint pain, muscle pain, back pain, and spinal stenosis. She wanted to know if the COVID-19 vaccine can cause the adverse event that she experienced. She wanted to know if it is like a sciatic nerve pain she is experiencing. The patient stated it may sound crazy, but she got the COVID 19 vaccine on Monday, she is 72 years old, and has a lot of back issues, like sciatic has a lot of problems, and she got the shot and Tuesday) morning, her back hurt so bad, down into her sciatic, into her butt, leg, her lower leg and as far as her foot, the top of her foot, and she doesn't know if this is something that was going to happen, she read about joint pain, tiredness, that would include joints in the back, she would expect. She wonders if she is out of her head, since it was the very next morning, this was Tuesday, and instantly, she was sitting with ice and trying to get ahold of her healthcare person, she gets pain shots in her back, but she hasn't had them in a couple years, she was going along pretty good, then this was bad enough, it is in her thigh and leg, and is always under her foot, and she just thought it was swelling in her spine. She wonders if it is a side effect or her imagination. When asked for address, the patient stated her brain is going blank. She stated this may be just her. She has bad back problems, and was going along pretty good, it has been a year or two since she has had any kind of anything. But this was a good one, a strong one, the ice hurts so bad. She woke up with it, it is staying the same- after having something like this, she was trying to get ahold of the pain clinic, to get a shot, but that may be 3-4 weeks out. She has had no blood work in a while. Outcome of the events "she just thought it was swelling in her spine" and "her brain is going blank" was unknown; while not recovered for other events.
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| 72 | 2021-01-25 | limb discomfort, limb discomfort |
Experiencing vision blurriness, dry eyes, - utilizes eye drops and resolves. Feels "heavy" some sne...
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Experiencing vision blurriness, dry eyes, - utilizes eye drops and resolves. Feels "heavy" some sneezing too.
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| 72 | 2021-01-26 | neck pain |
extreme chills; neck is aching; right arm pain; the pain prevented her from sleeping; Itching; This ...
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extreme chills; neck is aching; right arm pain; the pain prevented her from sleeping; Itching; This is a spontaneous report from a contactable consumer report self. This 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at right arm on 12Jan2021 15:30 at single dose for covid-19 immunisation. Medical history included had COVID back in Nov2020, blood cholesterol abnormal. Concomitant medication included Pravastatin for blood cholesterol and unspecified water pill. No prior vaccinations within 4 weeks. No additional vaccines administered on same date. Patient received Pfizer covid vaccine on 12Jan2021 around 15:30. Her right arms started getting in pain about 11pm and the pain prevented her from sleeping most of the night till she took an Aleve around 6am. She took another Aleve on 13Jan2021. She can barely raise her right arm and it is ok if she does not try to use it but if she tried to use her right arm then it is inoperable. At 12Jan2021 night after she got the vaccine she experienced itching, she never got a rash, the itching never got bad and it went away. She has not taken her temperature. She was having extreme chills that started around 13Jan2021 3:00 pm and she cannot get warm, she has blankets piled on her. Her neck is aching (started 13Jan2021 afternoon) and she thought this may be from tensing up since she is cold. No emergency room or physician office visit. The outcome of "Itching" was recovered, of else events was unknown. Information on the lot/batch number has been requested.
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| 72 | 2021-01-27 | muscular weakness |
Started with stomach twinges, went away ,5minutes later another hit. Went to eat and when finished m...
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Started with stomach twinges, went away ,5minutes later another hit. Went to eat and when finished meal I started to get double over pain we went home and that took 15 min. The pain was sharp and continues for a total of 30 min. I payed down with heat pad then it went away .since then I feel very tired, no energy,and my arm still feels weak and sore after the first shot .today I go for the second one.
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| 72 | 2021-01-27 | neck pain |
Bruise; Pain; Have horrific pain in back of my neck and head into my neck and not a headache; I can'...
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Bruise; Pain; Have horrific pain in back of my neck and head into my neck and not a headache; I can't turn my neck; Have horrific pain in back of my neck and head into my neck and not a headache; I can't turn my neck; wondering hurts to open my mouth and swallow; wondering hurts to open my mouth and swallow; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 23Dec2020 at a single dose on upper left arm for COVID-19 immunization. Medical history included Heart stents, Lupus, Type II Diabetes, rheumatoid arthritis (Autoimmune disease), anticoagulant therapy, cardiac disorder. Concomitant medication included clopidogrel for "My heart, it's a blood thinner", carvedilol, lisinopril, and amlodipine besilate all for heart related, hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for rheumatoid arthritis, rosuvastatin, semaglutide (OZEMPIC) for type II diabetes, citalopram, cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), moringa oleifera (MORINGA [MORINGA OLEIFERA]), and unspecified blood thinners. The patient stated, "I received the Pfizer immunization for COVID-19 on 23Dec2019 (later confirmed), and I am due to have my second dose this week and I was fine and I had just some size a small bruise. But I'm on blood thinners (further clarified and captured in medical history, hence not captured as suspect product in the tab), so I didn't think anything of it and a little pain but it went away. And then, this past Monday, which is into my third week, I have a horrific pain in the back of my neck and head into my neck and it's not a headache. It's pain and it's in the back of my head and into my neck and I can't turn my neck, right or left or up or down. It hurts to open my mouth, and it almost hurts to swallow and I am wondering if this is a reaction, so they have a delayed reaction. Is this swollen lymph nodes?" The patient stated, "I had lab work done this past Monday. I have no results yet." Therapeutic measures were taken as a result of bruise, pain, have horrific pain in back of my neck and head into my neck and not a headache; I can't turn my neck, wondering hurts to open my mouth and swallow which included ice packs and Aspirin. The outcome of the events was unknown.
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| 72 | 2021-01-28 | neck pain |
pain all around her neck; feeling dizzy; feels kind of weak; she can't think straight; feels like he...
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pain all around her neck; feeling dizzy; feels kind of weak; she can't think straight; feels like her head is big; she didn't feel good; headache; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), intramuscular on 14Jan2021 12:00 at a single dose on left arm for COVID-19 immunization. Age at vaccination: 72 years old. Medical history included hypertension, infection (term highlighted by the reporter: Yes; patient was admitted to a hospital from 29Dec2020 to 30Dec2020 due to infection), dyspepsia (reported as stomach, digestion), psoriatic inflammatory arthritis (she receives infusions for her arthritis once a month), sinus infection/sinus problems a month or two months ago, had cancer back in 1996 (had lumpectomy), stomach problems, and gastric endoscopy. Ongoing concomitant medications included losartan potassium, hydrochlorothiazide, omeprazole, and methotrexate. Other concomitant medications included folic acid, and plantago ovata (METAMUCIL). The patient had a regular flu shot a month ago (Dec2020). She can't remember when. The patient experienced headache on 14Jan2021. At the beginning, she had one, but then she got home, and the headache was like in the back of her head, like in her neck. She had pain all around her neck. She was feeling dizzy. She was able to sleep, however, the pain in her head is still there. She took aspirin along with her regular medication. When providing details, the patient made the comment that she can't think straight. She also has sinus problems, so she doesn't know if she has a headache from the sinus problems or because of the shot. She doesn't have a fever. She just feels like her head is big. She sees the date of when she is supposed to return for her second vaccine, 04Feb2021. She sees the lot number and then it has (name of center). The actual dose is unknown, she knows this is her first dose. She also receives infusions for her arthritis. She receives an infusion at a facility once a month, she used to receive it less than that, but her arthritis has been really bad, so she now does it once a month. She was supposed to go today but she didn't go because she didn't feel good. She had three COVID tests done because she had the sinus situation going on. A COVID test was done yesterday (14Jan2021) and it was negative. Another one was done when she had a gastric endoscopy on 09Dec2020. This test was also negative. She doesn't remember if she had another one in Dec2020 when she was at the emergency center, but all of her COVID tests have been negative. The patient has not recovered from headache. Outcome of the rest of the events was unknown.
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| 72 | 2021-01-28 | neck pain |
awful burning in the chest/pain in her chest; horrible pressure and pain in her chest; nausea; felt ...
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awful burning in the chest/pain in her chest; horrible pressure and pain in her chest; nausea; felt woozy; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246), via an unspecified route of administration in the right arm on 13Jan2021 at 17:39 at a single dose in the hospital for covid-19 immunisation. Medical history included anxiety, seizures, and high cholesterol. She passed out last summer and they put her in the hospital from 31Aug2020 and ran all kinds of tests. In the end, they said she only had a few PVCs (premature ventricular contractions) and she doesn't need to see the doctor for a year. Mentioned she also has chronic bronchitis and this is related to having low platelet count and low immunity. All of these events predate treatment with Pfizer COVID 19 vaccine. Concomitant medication included amlodipine, atorvastatin for high cholesterol, clonazepam for seizures, escitalopram for anxiety, levothyroxine sodium for thyroid, and mirtazapine for sleep; all were ongoing. Stated that she had something weird happen after her injection about four hours after the shot. She received the first dose of the Pfizer COVID 19 vaccine on 13Jan2021 at 17:39 in the right arm. About three or four hours later on 13Jan2021, she was getting ready for bed and when she sat down and leaned over she had a god awful burning in her chest and nausea. She was going to take baking soda but when she sat up she had horrible pressure and pain in her chest and felt woozy so she sat on the floor and then the pain started to radiate through her arm and into her neck. The horrible pain and pressure in her chest felt like something was sitting on her chest and the bad pain in her chest was going into her arm and a little into her neck. She laid real still on the floor, and did a lot of praying, and then 20 minutes later it totally stopped. She got up slowly and finished getting ready for bed and was fine. She was just hoping they will still let her get the second shot. The whole event only lasted 20 minutes and when it was over it was completely gone. She did tell her husband when he came home. She was alone when this happened. The patient wanted to know if she can receive second dose of vaccine. She stated it almost felt like a heart attack. She was planning to get the second dose on 03Feb2021. Wanted to know if her effect will preclude her from getting the second dose of the vaccine. Outcome of the events was recovered on 13Jan2021.
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| 72 | 2021-01-31 | muscle fatigue | severe muscle cramps , muscle fatigue , low grade temp |
| 72 | 2021-02-01 | neck pain |
her right arm began having a shooting pain that went up to her neck and left breast; her right arm b...
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her right arm began having a shooting pain that went up to her neck and left breast; her right arm began having a shooting pain that went up to her neck and left breast; her right arm began having a shooting pain that went up to her neck and left breast; Indigestion; dry mouth; blood pressure was high; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8982) via an unspecified route of administration on the left arm on 15Jan2021 at a single dose for COVID-19 vaccination. Medical history included ongoing heart murmur. There were no concomitant medications. She received the first dose of COVID vaccine on 15Jan2021 in her left arm. Patient stated that 15 minutes after receiving COVID vaccine her right arm began having a shooting pain that went up to her neck and left breast. She was given 4 Aspirin and a Nitroglycerin tablet. She was then transported to (Institute Name Withheld) by ambulance from vaccination facility. While at the hospital blood work was obtained and her pancreas was checked. Patient stated she was there for three hours. She would like to know if she should receive the second dose of the COVID vaccine? Reported she had an adverse event 15 minutes after receiving her first dose of the COVID-19 Vaccine. She said she had pain in her right arm. She said the pain went up to her neck. She said she had pain under left breast. She said she felt like she had indigestion. She said she was told to chew 4 aspirins, clarifying she was given 4 aspirins by the ambulance staff that was at the scene to treat her. Reported she was told her blood pressure was high. She said she doesn't know what her blood pressure reading was because the ambulance staff would not tell her. Reported she noticed she had a dry mouth while she was being transported in the ambulance to the hospital. Reported she was transported by ambulance to the hospital emergency room in (City Name Withheld), (State Name Withheld). She said she was treated and released from the emergency room. Reported her neck pain was gone first, but she still felt like she had indigestion while being treated in the emergency room. Treatment: Reported the hospital staff had her drink something, and then her indigestion, and arm pain went away. She said the hospital did blood work and checked her pancreas. She said she has no information on her blood work results, saying the emergency room doctor didn't share her results with her. She said the emergency room doctor only mentioned that he was checking her pancreas. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. The events did not require a visit to physician office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event pain in arm was recovered in 15Jan2021, patient recovered from neck pain, breast pain, indigestion and dry mouth in Jan2021; and unknown for the other event.
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| 72 | 2021-02-02 | joint pain |
Headache, vomiting ,diarrhea, aching joints all over, low grade fever, slight cough ,sore throat, no...
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Headache, vomiting ,diarrhea, aching joints all over, low grade fever, slight cough ,sore throat, no taste or smell.
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| 72 | 2021-02-02 | muscle pain | Muscle aches, soreness at site of vaccine, diarrhea |
| 72 | 2021-02-04 | joint pain |
body aches/ body and legs aches; body and legs aches; joint pain; fatigues; chills; This is a sponta...
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body aches/ body and legs aches; body and legs aches; joint pain; fatigues; chills; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the right arm on 16Jan2021 at 18:15 at a single dose for COVID-19 immunization. The vaccination facility was a public health department. The vaccine was not administered at the Military facility. The patient had no additional vaccines administered on the same date of the Pfizer vaccine. Relevant medical history included gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. The patient had no family medical history. Concomitant medication included cimetidine for GERD, which she had been taking for years and years. The patient had no other vaccinations within four weeks prior to the first vaccination. The patient woke up on Tuesday, 19Jan2021, feeling off; she experienced body aches, joint pain, and fatigues. The symptoms (Sxs) were still ongoing. The patient had question regarding the side effects and duration: if these had been reported and was it normal to still feel the side effects and how long would it last for. The patient was also asking if these were indicative of something more serious. The patient added that her healthcare provider (hcp) told her to take 2 paracetamol (TYLENOL) every 6 hours; however, the Tylenol only lasted for 5 hours. The patient further asked that if she continued to have side effects, at what point should she be do something and wanting recommendations on management. The patient was also asking if the side effects would happen with the second shot. The patient further reported that she felt pretty good on Sunday and Monday (17Jan2021 and 18Jan2021), maybe just a little off, and stated that on Tuesday (19Jan2021), she woke up and started with the classic side effects body aches, joint pain, fatigue, and chills that had continued. She stated she was taking Tylenol 2 extra strength; it worked for about 5 hours and then the effects came back. The patient wanted to know if this was normal to last this long and had this been reported by others. She stated she had contacted her doctor and her doctor did not know. The adverse events did not require any visit to an emergency room or a physician office. Therapeutic measures were taken as a result of body aches/ body and legs aches, joint pain, fatigues, and chills. There were no relevant tests. The patient was not recovered from the events "body aches/ body and legs aches, joint pain, fatigues, and chills."
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| 72 | 2021-02-04 | groin pain |
I had no side effects from the vaccine, but 2 days later I started getting a severe pain in my righ...
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I had no side effects from the vaccine, but 2 days later I started getting a severe pain in my right groin area that spread to the left side also by the next day. The pain was severe and I wasn't able to walk for two days and even now, 9 days later, it still is giving me some pain. I don't remember hurting myself and I have no idea if the vaccine has anything to do with what happened, but I was told to report it . I called my healthcare provider and they told me to call the health dept and the health dept told me to go online and fill out this form.
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| 72 | 2021-02-04 | muscle pain | muscle aches, flu-like symptoms lost taste and smell 2/1/21 |
| 72 | 2021-02-07 | joint pain |
Mild ache in thighs and joints after second shot , similar to aches after performing new exercise at...
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Mild ache in thighs and joints after second shot , similar to aches after performing new exercise at gym. No treatment. After 48 hrs, symptoms are gone.
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| 72 | 2021-02-07 | joint pain |
1/21/2021, 4 pm, Covid-19 first shot, Pfizer, Lot EL3246 On 1/24/2021 at 5 am I had bad heartburn s...
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1/21/2021, 4 pm, Covid-19 first shot, Pfizer, Lot EL3246 On 1/24/2021 at 5 am I had bad heartburn so I got out of bed, took a couple of TUMS and sat in chair , At 6 am I went to get in bed and felt nausea and started to go to the bathroom but ended up fainting. When I came to I started vomiting., Then my husband had to help me off the floor and get to the bathroom. I was vomiting and had Diarrhea. My temperature was normal. When symptoms subsided in about a half hour time I realized my right foot, leg and knee hurt. At approximately 1 pm my daughter insisted that I go to the ER, where I was treated.They ran a bunch of test but did not find anything seriously wrong with me and sent me home.
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| 72 | 2021-02-07 | armpit pain |
received shot at 9:26am on 2/5 and felt arm tender and took 2 tylenol later in afternoon - woke up a...
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received shot at 9:26am on 2/5 and felt arm tender and took 2 tylenol later in afternoon - woke up around 2am Saturday 2/6 with body aches - headache -chills - took 2 more tylenol . Got up at 7am - still with same issues but with fever instead of chills and took 2 excedrin had symptoms on and off all day. On Sunday 2/7 - symptoms very mild only real discomfort was left arm still sore but ARM Pit really is sore. Took 2 excedrin and it made it mild discomfort. Only to wake up today Monday 2/8- with again really tender left arm pit & top of arm still moderately tender..
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| 72 | 2021-02-08 | muscle pain, joint pain |
10 hours post vaccination, chills, joint and muscle pain, intense thirst, severe fatigue, headache, ...
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10 hours post vaccination, chills, joint and muscle pain, intense thirst, severe fatigue, headache, and slept 8 hours following morning still muscle and joint pain, fatigue improved, and remained tired throughout the day.
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| 72 | 2021-02-08 | neck pain |
Dizziness, loss of voice, swollen tongue & back of throat, difficulty swallowing, extreme headache, ...
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Dizziness, loss of voice, swollen tongue & back of throat, difficulty swallowing, extreme headache, & extreme neck ache. EMT's on site gave me a shot of 50 mg of Benadryl in my right arm. Halted the symptoms from getting worse, but symptoms did not clear until 24-48 hrs later.
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| 72 | 2021-02-09 | armpit pain |
Burning sensation when vaccine was injected & the shot hurt. During the rest of evening my left arm...
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Burning sensation when vaccine was injected & the shot hurt. During the rest of evening my left arm was sore. During the night, I couldn't get comfortable because my left arm pit started to hurt and could tell it was somewhat swollen. Woke up next morning and I had a low grade fever and my lymph nodes were tender and hurt to touch. Fever lasted all day & into the late night day after vaccine, but the arm pit lymph nodes lasted three and a half days. They are still a bit tender but not swollen today (02/10/2021). I had NO body aches but a little chills.
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| 72 | 2021-02-10 | joint pain |
Injection site pain, tiredness, headache, joint pain, swelling, redness, feeling unwell, fast heart ...
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Injection site pain, tiredness, headache, joint pain, swelling, redness, feeling unwell, fast heart beat, dizziness and weakness. nausea.
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| 72 | 2021-02-10 | limb discomfort |
caller ( admitting physician) stated pt got the vax and then she got weak on 1/26/2021. Stated he f...
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caller ( admitting physician) stated pt got the vax and then she got weak on 1/26/2021. Stated he felt like she was lifting weight blocks. She went to Medical Center ER and was discharged and fell and in the parking lot. Pt came back to same ER 2 days later and was admitted w/ Guillain-Barre dx. Pt was then treated with IV Immunoglobulins. Labs; Sodium 132. BUN7 , Albumin 2.7, Glucose 112, WBC 3.5 HGB 10.4
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| 72 | 2021-02-10 | muscular weakness |
Date and time of vaccination: (list both if they received both shots): 1st: 1/18/2021, 2/8/2021 at 0...
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Date and time of vaccination: (list both if they received both shots): 1st: 1/18/2021, 2/8/2021 at 0900 Brand and lot of vaccine: Pfizer 1st#: el1283, 2nd#: el9263 Starting feeling chills in the afternoon, become worse in the evening. Fever of 101.5. C/o muscle weakness, fatigue. Feels like "covid symptoms". Taking Acetaminophen as needed. Site injection pain as well. Denies dizziness/neuro changes, SOB, chest pain or DIB.
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| 72 | 2021-02-10 | muscle pain | Achy, muscle soreness, fatigue, lack of appetite, diarreha |
| 72 | 2021-02-10 | neck pain, musculoskeletal stiffness |
This was scary like waking up with Bells palsy/her neck froze up/when she woke up she could not look...
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This was scary like waking up with Bells palsy/her neck froze up/when she woke up she could not look up, down, left or right/It was like her neck was frozen or paralyzed, the muscles would not move; the muscles would not move/She was doing anything to loosen the muscles; shooting pain in her head; She was in a lot of pain in her head and neck.; her neurologist confirmed it was a muscle issue; This is a spontaneous report from a contactable consumer who reported for herself, a 72-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration in the left arm, on 21Jan2021 at the age of 72 years, at around 16:00 at a single dose for COVID-19 immunization. Medical history included her left eye had a virus that was finally taken care of back in Mar2020 but took a year and a half to heal. She had 5 surgery on that eye from an unspecified date. Also, her left lymph node got filled with fluid and was swollen but the doctors were not concerned about it. She would see an ENT for this. The patient has been seeing a neurologist who has done brain scans and MRI's due to the loss of peripheral vision do to eye problems. The patient has no allergies and is basically healthy. Concomitant medications include unspecified "natural stuff". The reporter stated she had a pretty bad reaction with the vaccine and it took 3 days to get over, her neck froze up. She woke on 22Jan2021 with the frozen neck. She got the first shot on Thursday, 21Jan2021, and on Friday morning, 22Jan2021, when she woke up she could not look up, down, left or right. It was like her neck was frozen or paralyzed, the muscles would not move. Any effort to move her neck would send shooting pain in her head. She applied a heating pad, took Aleve, she took a couple of them, a massager, biofreeze, and stayed in bed. She was doing anything to loosen the muscles. The next morning she was able to look up and down but still not left or right. She did the same thing for treatment that day. On Sunday, 24Jan2021, she was better, was able to move her head 3 of 4 directions. She continued with the treatment she had been using and by Monday, 25Jan2021, her muscles loosed up and her neck worked again. She was sure it is muscles and when she called her neurologist confirmed it was a muscle issue. She was in a lot of pain in her head and neck. The patient was under care for her neck and head and wondered if this happened because this was a weak area, she did not know if related. The patient remarked she was scared to get the second dose due to the problems she had with the first. She heard that the second dose was the one with worse side effects. She was in bed 3 days with this first one. It was reported that the events did not require a visit to Emergency Room, and required visit to physician office. Patient called the neurologist due to the pain and was told to go to acute care to evaluate but she didn't go. The patient stated that this was scary like waking up with Bells palsy and was wondering if she would ever get better. She has never had anything like this happen to her before. She has to be attributed it to the shot. The patient needed guidance on getting the second dose, and had questions about side effects. The outcome of the events was recovering. Information on the Batch/Lot number has been requested.
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| 72 | 2021-02-10 | neck pain | foggy feeling, dizzy, pain from injection site up neck |
| 72 | 2021-02-11 | joint pain, muscle pain | Side effects - Headache, Muscle pain, Chills, Joint pain, Fast Heartbeat |
| 72 | 2021-02-12 | muscle pain |
2/11/21- (Chills, excruciating headache, nausea, dry heaves, no appetite, muscle ache, fatigue, very...
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2/11/21- (Chills, excruciating headache, nausea, dry heaves, no appetite, muscle ache, fatigue, very weak) 2/12/21- (chills, weak, diarrhea)
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| 72 | 2021-02-12 | muscle pain |
Woke up with chills and all over muscle pain. Went back to sleep, In the am had nausea, headache and...
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Woke up with chills and all over muscle pain. Went back to sleep, In the am had nausea, headache and 99.5 fever. Took tylenol; side effects went away later that day on 02/11/2021.
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| 72 | 2021-02-14 | joint pain |
rotator cuff problems and took naproxen sodium (ALEVE) every day for this shoulder pain; rotator cuf...
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rotator cuff problems and took naproxen sodium (ALEVE) every day for this shoulder pain; rotator cuff problems and took naproxen sodium (ALEVE) every day for this shoulder pain; This is a spontaneous report from a contactable consumer reported for herself. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL8982 via intramuscular route at right deltoid on 26Jan2021 16:30 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. On unknown date the patient experienced rotator cuff problems and took naproxen sodium (ALEVE) every day for this shoulder pain as recommended by her HCP. The patient was unable to remember if she took an Aleve before or after she received the vaccine. She would like to know if this will interact with the vaccine. The outcome of the events was unknown.
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| 72 | 2021-02-14 | muscle pain | Very uncomfortable muscle pain in limbs |
| 72 | 2021-02-16 | muscle pain |
Rash at injection site arm was warm. Several days after this has pain in right arm felt like in the ...
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Rash at injection site arm was warm. Several days after this has pain in right arm felt like in the muscle. Still have pain in the arm and two red spots on ly arm.
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| 72 | 2021-02-17 | musculoskeletal stiffness | Mild soreness and stiffness in left arm. |
| 72 | 2021-02-18 | musculoskeletal discomfort |
Tingling in groin area, tongue, neck, chin and finger right after injection. Went away in about 15 m...
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Tingling in groin area, tongue, neck, chin and finger right after injection. Went away in about 15 min. 6 hrs later got hot spot burning under my skin in my chest, under my left arm pit to elbow and neck and lower legs. This continues when I get anxious. Like a sunburn just under the skin
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| 72 | 2021-02-20 | armpit pain, muscle tightness, back pain |
About 6 hrs. after vaccine I developed mild flu like symptoms: fatigued, body aches, headache, flus...
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About 6 hrs. after vaccine I developed mild flu like symptoms: fatigued, body aches, headache, flushed, temperature was one degree above normal for me, but technically not a fever. I had symptoms people get after the second vaccine, after this, my first vaccine. If I was still working I would have needed to take two sick days. Theses symptoms lasted only a little over two days, but the the body aches continued for weeks. My legs felt sore, tight and sometimes crampy, and both of my upper arm pit areas were sore. Areas of my back were also sore off and on. I otherwise felt okay. Leg pain has gradually gotten better, with little to no leg pain today. I feel these symptoms are a reaction of my immune system to the vaccine. Is it safe to get the second vaccine if I?ve had this prolonged reaction to the first? I don?t want to do anything to jeopardize my health.
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| 72 | 2021-02-20 | armpit pain |
First vaccine - side effects lymph nodes in right armpit, lasted 5 days Second vaccine side effects ...
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First vaccine - side effects lymph nodes in right armpit, lasted 5 days Second vaccine side effects - lymph nodes swollen and very sore in left armpit started 2-18-21 and still uncomfortable today 2-21-21.
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| 72 | 2021-02-20 | neck pain, back pain, joint pain |
day after vaccine:sharp little head pains, very sore neck on left side and upper shoulders & back. l...
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day after vaccine:sharp little head pains, very sore neck on left side and upper shoulders & back. later same day chills in upper torso only, lethargic. day 2, fine. day 3 &4 re and swelling from above elbow to shoulder-left arm, then continued on left clavicle to chin line on left. I have a 3" area in the middle of that from shoulder to clavicle that is unaffected. Looks like sunburn lines
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| 72 | 2021-02-21 | joint pain, muscle pain |
the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredne...
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the swelling of my face and throat; the swelling of my face and throat; injection site pain; tiredness; headache; Muscle pain; joint pain/joint pain in her knees; hot flashes to where she would nearly pass out a couple of times; hot flashes to where she would nearly pass out a couple of times; nausea; face and everything was red; Dizzy; weak; chills; Feeling unwell; I had difficulty breathing; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) on her right arm, via an unspecified route of administration on 26Jan2021 15:30 at SINGLE DOSE for covid-19 immunization. Medical history included multiple myeloma, Kidney failure, dialysis; all on Aug2020 and ongoing and cancer. The patient's concomitant medications were not reported. The patient previously took an unspecified flu shot for swine flu but had a terrible reaction (allergies). It was reported by the patient had injection site pain in her right arm the next day after vaccination. Stated that she had tiredness, headache, muscle pain, joint pain in knees, hot flashes to where she would nearly pass out a couple of times, nausea that was very bad for two days. Stated that her face and everything was red, dizzy and weak and had chills. Stated that it has been eight days since she can do that. Stated that she took Extra Strength Tylenol for headache. The patient also stated that she was feeling unwell, that started on the 27th until today. She also had difficulty breathing that has lasted 8 days, the swelling of her face and throat on the 31Jan2021 for one day. The outcome of the event tiredness was recovering, unknown for events chills, feeling unwell, difficulty breathing and swelling face, while recovered for the other events.
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| 72 | 2021-02-21 | muscle pain | very achy muscles, headache lasted over a week, tired |
| 72 | 2021-02-22 | muscle pain, limb discomfort |
angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy...
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angina; angina; Fever; Chills; Cough; Sore throat; runny nose; Nausea; Diarrhea; Headache; arm heavy; muscle aches and heaviness; muscle aches and heaviness; she just woke up feeling sick; fevers may come like a hot flash; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Unknown), via an unspecified route of administration on 23Jan2021 at a single dose, in left arm for COVID-19 immunization. Medical history included fibromyalgia diagnosed years ago, angina (some stents). There were no concomitant medications. On Jan2021, the patient experienced angina, fever, chills, cough, sore throat, runny nose, nausea, diarrhea, headache, arm heavy, muscle aches and heaviness, and she just woke up feeling sick. The patient experienced multiple AEs after 1st dose of vaccine (received on 23Jan2021). The patient experienced angina later last week. Clinical course: The patient has misplaced card, states her second appointment for the second dose is this Saturday. Caller stated she started having these experiences the day after she was vaccinated with her first dose, received first dose of 23Jan2021. She had fevers, chills, cough- not an aggressive cough, a funny kind of sore throat- like something wrapped around her throat like the muscles of her throat, no congestion but does have a runny nose, states she has some nausea, no vomiting but feeling like she needed to vomit and diarrhea, and headache. The symptoms started about the third day after the vaccine, started with the fevers, stated the fevers may come like a hot flash, lasts seconds even, states you know it is a fever because your bones get hot. These symptom's did not attack her body at one time. Her whole arm stayed heavy, the whole arm not just the injection site, for almost 10 whole days. She previously had fibromyalgia and thought maybe that made the symptoms worse. She had muscle aches and feeling heavy. Her symptoms were spread out over time, no two were at the same time, sore throat was one of the last things. Diarrhea was ongoing, not a runny diarrhea but it was enough to empty stomach and was soft. She was a medic in the military, worked as a Nurse, clarifies she was an LPN and took all the underlying courses to be a PA. One of the issues she found, she thought it may be deadly, as a prior healthcare person and in tune to her body, the people who are in the nursing homes may not be mobile, states so one of the things she felt was just feeling really really sick, that she couldn't put a pin point on it, states she just woke up feeling sick, states she had the urge to get out of bed and got up and after she got up the feeling left her, states a person in the nursing home may just feel really bad and cannot get up, thinks a protocol should be that the people that are immobile should be required to move or if they can't get up they need to move their muscles, people with these symptoms need to get up and get moving. She also has history of angina and a stent, has not had angina in a while and had 3 days where she thought she may need to go talk to her doctor. It was on Wednesday, Thursday and Friday this week. States one of her friends, 92 years old, said she got high after the vaccine and didn't want to talk to anybody, states it was her first dose, she was kind of leery about the 2nd shot, feels like this was kind of aggressive. She had both doses and had no symptoms, but 92-year-old female had no symptoms right away, other than normal body aches and pains, but the next day was high as a kite. Her son has heart disease and she advised him not to take it right now. They were losing a lot of people to the vaccine in nursing homes, no further information provided. This could be affecting good hearts more than damaged hearts, read that this virus likes to work in parts of the body that are already damaged. The outcome of event diarrhea was not recovered, outcome of the other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, a causal association between the reported angina and BNT162B2 cannot be completely excluded. Note however, that the patient has underlying angina with some stents that may also have contributed to the event. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 72 | 2021-02-24 | joint pain, muscle pain | Fatigue, headache, Muscle/Joint Pain, Chills, Feeling unwell, dizziness |
| 72 | 2021-02-25 | muscle pain |
None for first injection. Second injection started with extreme chills, moved to headache, muscle ac...
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None for first injection. Second injection started with extreme chills, moved to headache, muscle ache, weakness. Lasted 24 hours, mitigated with Tylenol. 10 days later, still suffering intermittent fatigue, weakness, inflamed lymph node near left breast, diarrhea and muscle ache.
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| 72 | 2021-02-25 | neck pain, back pain, joint pain |
pt stated that the same day after getting the vax she developed neck pain, fever, joint pain in arms...
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pt stated that the same day after getting the vax she developed neck pain, fever, joint pain in arms, hands and knees, a splitting headache, also had pain in her ears, face, and upper back. Next day the pain was worse. Pt contacted her PCP and was told to report to VAERS. She still has pressure in her head, eye, ear ache and cant do regular every day activities.
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| 72 | 2021-02-26 | armpit pain |
Started experiencing severe pain in my armpit of the right arm where I got shot. Pain two days later...
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Started experiencing severe pain in my armpit of the right arm where I got shot. Pain two days later is still bad. Touching my armpit or sitting still doesn't make any difference. Pain is annoying and hurting. Took 2 Tylenol,thinking it would relieve pain, but it hasn't helped.
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| 72 | 2021-02-28 | joint pain |
Approx 5 minutes after receiving the vaccine client started c/o tingling, clammy, flushed apperaranc...
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Approx 5 minutes after receiving the vaccine client started c/o tingling, clammy, flushed apperarance. States she is on beta blockers and gets light headed often. no medications given. Client recovered quickly. This information was obtained by her daughter. She denies any problems with her first dose, and only thing now is some soreness in her shoulder.
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| 72 | 2021-02-28 | muscle pain, neck pain |
One week after shot, on 2-27 21, I awoke with splitting headache, muscle pain in my neck, nausea, a ...
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One week after shot, on 2-27 21, I awoke with splitting headache, muscle pain in my neck, nausea, a few chills (they did not last long), felt horrible for about 5 hours. I threw up midway, and then just slept. Felt a little better around 2:00 pm, took Tylenol at 4:00pm and that helped a lot. Got out of bed at 5:00 pm. Was able to eat a little dinner at 6:00 pm. Went back to bed around 9:00. Felt better in Am -Sunday, Feb 28; not 100% though. Tired. Long nap. Better today, Mar. 1. -- just a little off - woozy.
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| 72 | 2021-02-28 | muscle pain |
Too long to have muscle pain from a shot; Migraine headache; severe arm pain where the shot was inje...
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Too long to have muscle pain from a shot; Migraine headache; severe arm pain where the shot was injected; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261; expiration date not provided), via an unspecified route of administration from 21Jan2021 to 21Jan2021 at SINGLE DOSE for an unspecified indication. Medical history included 'thyroid' from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine from an unspecified date and unknown if ongoing at 100 ug, 1x/day for 'thyroid'. Patient stated that she spoke with her physician's assistant. Patient received vaccine on the 21st of January, the first shot at her local place. The following morning at 4 in the morning, patient had severe arm pain where the shot was injected. So patient put a hot compress on it and took some paracetamol (TYLENOL). Patient mentioned that it didn't relieve for about an hour and a half. Patient meant the pain was really severe but finally it went away. The next day, it came back again and then the patient did it again and the pain keep coming back. Patient stated "And now it's been tomorrow will be a week. And that's too long to have muscle pain from my shot". Patient also mentioned that second day after the shot, migraine headache started. Patient stated, "Now I get them, but I only get them in the spring and I get them in the Fall. I don't get the migraine headaches in the winter time. I could only take Excedrin Migraine for the migraine, it's just over the counter medicine. And so I took that for the headache but those have not gone away either. When patient contacted her physician's assistant just now, it was reported that patient the physician's assistant is going to write a prescription for a muscle relaxer. Patient also reported that she is not going to take that second shot as she didn't know where to go to cancel it but she is not taking it. Patient mentioned she can't have pains like this. Patient stated that she can't tolerate pain to begin with, let alone have excess pain in her system. Patient added that she doesn't take medications. She is only on a thyroid medication (later confirmed the name as levothyroxine). Patient confirmed that the vaccine was Pfizer COVID-19 vaccine. When probed for the due date of the next shot, patient stated 'February 11th at 12 o' clock'. Patient also stated 'I am not getting it, I am not taking the second shot. I didn't get you, I don't know what you said. I am not understanding you. I am not getting what you are saying. I am not taking the second shot, it is scheduled for February 11th of 2021, I am not taking it. Because they called and asked if I wanted to receive it and my age is almost 73. So, I thought I probably should give it a chance. But now with the reaction I don't want the second one' and 'I don't know if there is something wrong with this phone or something wrong with the connection, I don't understand, I get part of it but I don't understand the other part. It blanks out, I don't know what's wrong, you are asking me something, but I don't know what it is'. Patient also reported that the pain started the day after she got the shot, 22Jan2021. Patient is still having pain. Patient also confirmed that TYLENOL was the treatment for pain but it was not working. Medication for migraine was reported as EXCEDRIN migraine. Patient further confirmed EXCEDRIN Migraine did not help with the migraine and stated 'No, I still have it, it gives me some relief but then after wears off it comes back, the migraine comes back'. Patient further added "Okay, I am just going to rely on my physician assistant, she has got some medication ordered for me, a muscle relaxer. And I am going to try that and see if that will make everything go away". Outcome of the events 'severe arm pain where the shot was injected' and 'migraine headache' was not recovered; outcome of the remaining event was unknown.
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| 72 | 2021-02-28 | muscle pain |
fever, chills, muscle ache, headache, cough, nausea (mild), fatigue, sore arm, injection site pain o...
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fever, chills, muscle ache, headache, cough, nausea (mild), fatigue, sore arm, injection site pain onset 12 hours after receiving the vaccine ongoing at this point
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| 72 | 2021-03-01 | joint pain |
I had a hip replacement in my left leg in 2002. The evening that I had my vaccine I had quite a bit...
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I had a hip replacement in my left leg in 2002. The evening that I had my vaccine I had quite a bit of pain in that hip. It did go away by the following morning but I felt that you might want to know about it.
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| 72 | 2021-03-02 | joint pain |
Has a small, walnut sized lump on her left arm where the injection was; having increased arthritis p...
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Has a small, walnut sized lump on her left arm where the injection was; having increased arthritis pain; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (lot EL3247) via an unspecified route of administration in the left arm on 23Jan2021 at a single dose for COVID-19 immunization. Medical history included Covid prior to getting the first shot (has had Covid). Concomitant medications were not reported. It was reported that the patient has a small, walnut sized lump on her left arm where the injection was on Jan2021 that has been there for about a week. She wanted to know what to do about the lump and if she should get the second shot. It was also reported that she's having increased arthritis pain on 2021. She's going to a state on 28Feb2021 and would have second shot on 23Feb2021 and she needed a negative Covid test 72 hours prior to going. She wanted to know how would she get a negative Covid test. The outcome of the events was unknown.
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| 72 | 2021-03-02 | back pain, musculoskeletal chest pain, musculoskeletal pain, muscle pain |
while she was on the top step of a 2-step stool, her left leg went out from her, and she fell straig...
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while she was on the top step of a 2-step stool, her left leg went out from her, and she fell straight back, landing on the floor; her left knee keeps wanting to go out/ left leg kept wanting to buckle under her; she has 2 big bruises on arm, 1 bruise at her elbow and 1 bruise on her upper arm.; horrible pain in her left back/ pain was above her left kidney, and the pain ran from the bottom of her left rib cage to the bottom of her left butt cheek; pain ran from the bottom of her left rib cage; caller experienced pain from her kidney to her butt cheek; her arm was mildly sore; her left leg muscle is sore from above her left knee; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 22Jan2021 10:00AM at a single dose on the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to receiving bnt162b2. Medical history included COVID-19 in Nov2020 and lost taste and smell. Reported she tested positive for the COVID-19 Virus in Nov2020. She said she was never sick during the time she had the COVID-19 Virus, though she lost her sense of taste and smell. She said she may have had a headache during that time, but she doesn't know if the headache was from the COVID-19 Virus or something else. She said anything she was experiencing during the time she had the COVID-19 Virus was kind of normal for her. Concomitant medications were none. Reported she got her first dose of the COVID-19 Vaccine on Friday, 22Jan2021, and thinks she may be having an adverse reaction. She said after she received her COVID-19 Vaccine, she was OK for the remainder of Friday, 22Jan2021, as well as, Saturday morning, 23Jan2021. Reported she was working outside the day before she had her first COVID-19 Vaccine dose (21Jan2021). She clarified she had a tree cut down in her yard, and she moved all the 3 foot length cut-up pieces of tree by herself. She had been moving tree cuttings. Her arm was mildly sore. Reported on Saturday (23Jan2021) in the middle of supper, she experienced a horrible pain in her left back. She clarified that the pain was above her left kidney, and the pain ran from the bottom of her left rib cage to the bottom of her left butt cheek. She said the pain was so bad she didn't think she was going to be able to finish eating supper. She said after supper she got on a heating pad and walked around the kitchen to see if that would help with the pain. She said she sat on the heating pad and walked around the kitchen 4 times that night. She said by Sunday (24Jan2021), the pain started to go away, and by Sunday night, she was OK. Reported this past Thursday, 28Jan2021, she was going to her mailbox. She said while she was walking out to her mailbox, she was holding onto her front porch post to go down the front porch stairs, and her left leg collapsed out from under her. She said she would have fallen if she wasn't holding on to the front porch post. She said she tried to continuing walking to the mailbox, and her left knee went out from under her again. She said her left leg kept wanting to buckle under her. She said after she got back inside her house, she sat down in a chair to read a book. She said she was making soup at the time and grabbed her husband's cane to walk to the kitchen. She said she is short and got on her 2-step stool to look in the freezer for vegetables. She said while she was on the top step of the stool, her left knee buckled and her left leg went out from under her. She said she fell straight back, landing on the floor. She said she has 2 big bruises on arm, 1 bruise at her elbow and 1 bruise on her upper arm. She said her left leg went out from under her again, yesterday (31Jan2021), while she was going to church. She said everything she has experienced since getting her COVID-19 Vaccine shot is only happening on her left side. Reported her left knee keeps wanting to go out and she has to be really careful when she walks. She said her left knee feels like it is wanting to buckle, like when someone runs up behind you and hits the backside of your knee. She said her left leg muscle is sore from above her left knee. She said she doesn't know if what she is experiencing is from getting her first COVID-19 Vaccine dose, and she wanted to know if anyone else has reported a similar experience since receiving the COVID-19 Vaccine. For fall treatment, she took a couple of Aleve 220mg tablets (UPC Number: 325866555090, Lot Number: NAA6W3T, Expiration Date: Jun2021) on 28Jan2021, after she fell off her stool. Reported she took another 2 Aleve 200mg tablets last night (31Jan2021) at 11:00PM. Reported she is pretty darn healthy and only takes 3 pills. No other details provided. Reported she is trying to lock her left knee when she walks, saying she can feel her left knee giving away. She said she while she was walking down a small ramp at church on Sunday (31Jan2021) her left knee wanted to buckle from under her. She said she had to hold onto a railing while she was walking down the ramp, so she wouldn't fall. She said she is not used to her left knee trying to go out from under her. The reported adverse events did not require a visit to the emergency room or physician office. Outcome of events "horrible pain in her left back/ pain was above her left kidney, and the pain ran from the bottom of her left rib cage to the bottom of her left butt cheek" (back pain, rib pain, and buttocks pain) was recovered on 24Jan2021. Outcome of "her left knee keeps wanting to go out/ left knee kept wanting to buckle under her" (joint instability), and "her left leg muscle is sore from above her left knee" (myalgia) was not recovered. Outcome of the remaining events was unknown.
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| 72 | 2021-03-02 | muscle pain, muscle tightness, musculoskeletal stiffness |
hands, feet, toes and entire body, felt almost paralyzed; not being able to turn over in bed; could ...
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hands, feet, toes and entire body, felt almost paralyzed; not being able to turn over in bed; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; could not bend her fingers or toes; muscles throughout her body remained stiff and tight; tense muscle aches; Chills; headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) at the age of 72-years, via an unspecified route of administration in left arm at 11:00 AM on 16Feb2021 at single dose for COVID-19 immunisation, in hospital. Medical history included pituitary microadenoma from 1969 (52 years) and in good health other than the fibromyalgia; allergies to latex. Patient was not pregnant, was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included desipramine; duloxetine hydrochloride (CYMBALTA); ergocalciferol (VIT D); zinc. The patient previously received first single dose of BNT162B2 (lot number: EK9231) at the age of 72-years via an unspecified route of administration in left arm at 04:00 PM on 25Jan2021 for COVID-19 immunisation. Patient reported that she had been diagnosed with fibromyalgia and saw a rheumatologist that specializes in treating fibromyalgia. At 01:00 AM on 17Feb2021, fourteen hours later, she awoke to not being able to turn over in bed. Her hands, feet, toes and entire body, felt almost paralyzed. She could not bend her fingers or toes. Her muscles throughout her body remained stiff and tight for the next 16 hours. Chills, headache but no fever. Patient took paracetamol (TYLENOL) every four hours, during this time. It did not help with the tense muscle aches. Later on 17Feb2021 (that same day), approximately 19:00 (7:00 PM), her muscles started to relax. Patient was writing this the day after and she felt fine. She could hardly wait for the booster shot. Outcome of the events was recovered/resolved in Feb2021. Since the vaccination, the patient has not been tested for COVID-19.
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| 72 | 2021-03-02 | neck pain, muscle pain |
Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash ...
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Headache, fever, swollen arm at injection site burning, rash, muscle ache, overall discomfort. Rash appeared day after injection as well as burning. Day of injection tired, arm very sore, didn't sleep well followed by feeling really sick nausea, just a little, then fever started terrible headache continued until next evening. Now arm sore also realized I have neck pain yesterday and now, still have rash the burning has subsided
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| 72 | 2021-03-03 | joint pain, neck pain |
second dose soreness in left arm, Nightime pain in right arm; cold not full chills but cold; shoulde...
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second dose soreness in left arm, Nightime pain in right arm; cold not full chills but cold; shoulder neck down to wrist very sharp pains like muscle cramps; shoulder neck down to wrist very sharp pains like muscle cramps; shoulder neck down to wrist very sharp pains like muscle cramps; This is a spontaneous report from a contactable 72-year-old female consumer reported for herself that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3247) single dose on 16Feb2021 09:00 AM at left arm for COVID-19 immunization. Medical history was not provided. Historical vaccine included 1st dose of BNT162B2 (EL3247) on 25Jan2021 at 11:30 AM at left arm for COVID-19 immunization. Concomitant drugs included lisinopril, levothyroxine sodium (LEVOTHYROXIN), pravastatin, vitamin D and vitamin K. The patient reported second dose soreness in left arm, cold not full chills but cold, Nightime pain in right arm, shoulder neck down to wrist very sharp pains like muscle cramps started on 17Feb2021 at 01:00 AM. No treatment was received for the events. Event outcome was recovered.
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| 72 | 2021-03-03 | muscle tightness |
i felt dizzy with my first vaccine on 2/5/21. ..it passed i started to feel dizzy/woozy/lightheaded,...
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i felt dizzy with my first vaccine on 2/5/21. ..it passed i started to feel dizzy/woozy/lightheaded, kind of seasick without the nausea almost 12 hours post 2nd vaccine. . this has continued now so far for 6 days. . it is more than brain fog.. it is a real sense of disequilibrium, like something is really affecting my brain. . . the base of my neck and spine have been incredibly tight and contracted with all the muscles in my head contracted. . this is more than a headache. .. i also seem to have the vaccine affecting my vision. . i know of 6 other people now that have similars symptoms and not all got pfizer
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| 72 | 2021-03-03 | musculoskeletal stiffness |
Numbness and slight swelling on entire left side of face within half hour following shot, accompanie...
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Numbness and slight swelling on entire left side of face within half hour following shot, accompanied by severe stiff neck (left side). Headache and slight transient facial rash with skin discoloration under eyes about two hours later. Mostly subsided by 10:30 PM- about eight hours later, although some numbness remained l through the night. Symptoms were mostly gone the next morning, replaced by arm soreness and bruising at the injection site. Black and blue remains (3 days later).
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| 72 | 2021-03-03 | neck pain |
Discovered a lump about three inches to the left of my throat while I was on my way to my doctor's o...
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Discovered a lump about three inches to the left of my throat while I was on my way to my doctor's office for my annual wellness exam when I felt a sharp pain near that area. I instinctively reached over and put my hand on the area and immediately felt a lump. My doctor examined me and asked me some questions about when I first felt the lump and how was I feeling, etc. I told her I had my second vaccine three days prior. She gave me a prescription for bloodwork which is part of my annual exam process along with an appointment to see me again on March 16th. I had the bloodwork yesterday morning.
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| 72 | 2021-03-04 | armpit pain, musculoskeletal chest pain |
STARTED AT 4PM ON 3/1/2021 WITH CHILLS, GENERALIZED BODY PAIN, FATIGUE, FEVER, LEFT ARM AND AXILLARY...
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STARTED AT 4PM ON 3/1/2021 WITH CHILLS, GENERALIZED BODY PAIN, FATIGUE, FEVER, LEFT ARM AND AXILLARY PAIN WITH DECREASED RANGE OF MOTION, RIB CAGE PAIN . TOOK TYLENOL
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| 72 | 2021-03-05 | muscular weakness | Extreme shaking, leg weakness, slight fever. I couldn?t move at all. It was like I was paralyzed. |
| 72 | 2021-03-06 | muscle pain, joint pain |
Heavy chest cough, fever, chills, body aches, slight nauseated feeling, problem sleeping,, got bette...
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Heavy chest cough, fever, chills, body aches, slight nauseated feeling, problem sleeping,, got better Saturday but then same symptoms returned Saturday night and continue today, joint pain, muscle pain
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| 72 | 2021-03-06 | muscle pain |
Almost immediately I got a headache. The headache intensified and muscle pain ensued. The muscles in...
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Almost immediately I got a headache. The headache intensified and muscle pain ensued. The muscles in my arms, legs and even the headache felt as if something inside was vibrating. It has been eight days, and none of the symptoms have abated. I am now very uncertain ifI can tolerate a second dose on March 20. I cannot take anything except Tylenol, and that doesn't touch the pain.
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| 72 | 2021-03-07 | muscle pain, joint pain |
I have now had my 2nd vaccination (3/1/21) and had the same reaction both times. I experienced seve...
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I have now had my 2nd vaccination (3/1/21) and had the same reaction both times. I experienced severe muscle and joint pain starting 12 hours after each injection; this lasted about 36 hours. I rested and took Advil and Tylenol. I think this reaction might have been because I received Bamlanivimad 11/24/20 as a treatment for Covid. Just a thought - I did not contact my doctor and after 36 hours I am fine - I would do it all over again in a hearbeat!! Just thought I would add my comments to your database. Thank you.
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| 72 | 2021-03-08 | joint pain, back pain |
Pain in left arm, across back and right shoulder, chest pain, headache, very cold, and severe weakne...
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Pain in left arm, across back and right shoulder, chest pain, headache, very cold, and severe weakness. It lasted about 4 hours, from 9am to 1:15pm.
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| 72 | 2021-03-08 | muscle pain |
Chills; Headache; Muscle aches; This is a spontaneous report from a contactable pharmacist. A 72-yea...
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Chills; Headache; Muscle aches; This is a spontaneous report from a contactable pharmacist. A 72-year-old non-pregnant female patient (reporter's mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 05Feb2021 at 08:00 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, fibromyalgia, sleep apnea. The patient was not diagnosed with COVID prior to the vaccination. The patient had no known allergies. Concomitant medications included hydrochlorothiazide/valsartan, celecoxib, duloxetine. There were no other vaccines administered within 4 weeks of the vaccination. On 06Feb2021 at 06:00, the morning after the vaccination, the patient experienced chills, headache, and muscle aches. The patient was treated for the events with 600 mg of ibuprofen and the symptoms subsided. Since the vaccination, the patient was not tested for COVID. The clinical outcome of chills, headache, and muscle aches was resolving. Information on the lot/batch number has been requested.
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| 72 | 2021-03-09 | joint pain, back pain |
On 2/26/2021, I had a soaking night sweat and a few other symptoms. After 72 hours, (3/1/2021) labi...
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On 2/26/2021, I had a soaking night sweat and a few other symptoms. After 72 hours, (3/1/2021) labile blood pressure rose; lymph nodes left neck, breast and spleen were enlarged and tender;pain/tenderness cont'd down left side lymph nodes. General ache and pressure across back (kidney area). After 2-3 days, lymph nodes on right side became tender. Labile blood pressure requires medication (generic norvasc) but still fluctuates. Pain in joints and slight "bloating" overall. Sinus mucosa completely dry (nasal). These symptoms continue as of 3/9/2021.
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| 72 | 2021-03-09 | joint pain, flank pain, neck pain |
Immediately upon leaving the COVID shot parking lot at Hospital, I began to feel pain shooting down ...
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Immediately upon leaving the COVID shot parking lot at Hospital, I began to feel pain shooting down my arm all the way to my fingertips. Then I started to feel disoriented. Then, as I was driving myself home, I felt constriction in my chest, like I was barely holding onto consciousness, then pain shooting up my shoulder into the left side of my neck, the left side of my face, my left eye and into the left side of my head. My heart was pounding, my head was hurting intensely and I wondered whether I was having a stroke while trapped in stop and go traffic. The intense pain continued while I drove, for about 30 minutes. Then it subsided somewhat -- but continued through the evening. I could not get to The pain continued in my arm, up the left side of my body and into my head all night. I could not sleep. My heart was pounding. Somehow I dozed off around 2 or 3am. The next day I felt groggy and tired, with the more moderate pain continuing in my arm and all the way to my hand. Finally, on Monday morning, I was able to reach my doctor's office. I was told to go the ER, which I did. They could find nothing "emergent." The pain, tiredness and headaches continued through Thursday. Friday I started to feel better -- a week after the shot on Saturday, 2/27.
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| 72 | 2021-03-09 | joint pain | extreme fatigue, unable to stand alone, extreme pain in joints, weakness, nausea, glassy eyes |
| 72 | 2021-03-09 | rheumatoid arthritis | Rheumatoid arthritis flare after both doses 1 & 2 |
| 72 | 2021-03-10 | joint pain, back pain |
Adverse Event: sore arm, could not raise right arm above should height, fever 100.4; onset at 4-5 h...
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Adverse Event: sore arm, could not raise right arm above should height, fever 100.4; onset at 4-5 hours after injection. Very tired; achy especially painful in knees and lower back. Took one Tylenol every 4 hours on Tuesday and Wednesday. Felt fine at 4:30 a.m on the 11th of March. Slept most of Tuesday from 5 p.m until next day. Wednesday, again achy, fever, exhausted, pain in joints, arm warm to the touch. Slept thru most of the day.
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| 72 | 2021-03-10 | weight decreased |
Left ear hurt 11 pm 1-25-21; Violent pain/claws ripping flesh off half of face/head 2 am 1/26/21; no...
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Left ear hurt 11 pm 1-25-21; Violent pain/claws ripping flesh off half of face/head 2 am 1/26/21; non-amblitory, could not support weight, major balance issues. Televisit 1/26/21=earache. Blacked out cold 5 min, non responsice 30 min 2 am 1/26/21; woke with Bell's Palsey; Ddumb televisit 1/28/21=BP. Urgent Care visit-EKG (normal), bloodwork, urine lab work. 2/1/21 Saw NEURO = MRI brain w/contrast to rule out cancer (2/4/21; Two weeks of solid hallucinations 24/7. Horrendous balance issues-almost non-amblitory from onset 1/26/21 to present. Lost 9 pounds in 2 weeks.(I was 104 now 95 pounds). I was walking 5 mi a day, walked 1/24/21, healthy. Devastating pain to left side of head/face, esp ear. PAIN
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| 72 | 2021-03-11 | muscular weakness |
3 days after receiving my 1st dose of the Pfizer Covid vaccine, I woke up with a numb, cold, weak l...
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3 days after receiving my 1st dose of the Pfizer Covid vaccine, I woke up with a numb, cold, weak left arm. No soreness in that arm prior to this event. I had a fine tremor on extension of my left arm. Symptoms resolved after 45 minutes , but returned within a half hour and repeated. I called my doctor and spoke to the advice nurse. I was adviced to go to the ER within one hour. Instead a did some deep breathing and relaxation and my symptoms resolved and have not returned. I spoke to a doctor and agreed to go to the ER if they returned and also discussed the symptoms with my primary doctor during a video visit and she adviced daily baby ASA.
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| 72 | 2021-03-11 | musculoskeletal stiffness |
muscle stiffness during morning walk, nausea while eating cereal, stood up and fainted some nausea w...
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muscle stiffness during morning walk, nausea while eating cereal, stood up and fainted some nausea while on floor for 2.5 hours sleeping three hours later
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| 72 | 2021-03-11 | muscle pain | Extreme overall muscle pain, tachycardia, rapid heartbeat constantly lasting over 24 hours |
| 72 | 2021-03-12 | muscle pain |
Within 15 seconds I got a sore throat. Within 5 minutes I had muscular pain all over body. Chills....
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Within 15 seconds I got a sore throat. Within 5 minutes I had muscular pain all over body. Chills. Felt very tired. Headache. Nurse checked oxygen level within 10 minutes and it was well above normal. Nurse put me in recliner and I slowly calmed down and felt sleepy. Left in one hour walking to car and driving home. These symptoms lasted 7 days. Very irritated for 7 days. Very uncomfortable.
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| 72 | 2021-03-12 | muscle pain |
I was fine when getting the injection and my ½ hour wait. I was fine during dinner and after dinner...
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I was fine when getting the injection and my ½ hour wait. I was fine during dinner and after dinner and until about 9 hours after the injection when my arm felt exceedingly sore. I had been watching a free Amazon Prime cute movie while knitting a blanket for my grandson. When the movie was over and I was clearing my knitting, I noticed my super sore arm. I got up to check my face in the mirror to be sure that I was not having a reaction. But I did have a reaction with a rash on my chest and face 9 hours after the injection. My arm really hurt for three days but is fine now. When I saw my red face and chest, I took a Zyrtex D and a Benadryl. It did not seem to help the redness to go away. When I felt some tightening of my throat and started to feel that I might be starting to lose some clarity of thought, I quickly watched a minute video on how to use my new kind of generic epipen and jabbed myself in the leg and called 911. I felt much better after the epipen in terms of my thinking and throat. Basically, the medics that came to the house and said that I had taken what they would give me at the hospital and it was up to me if I wanted to go to the emergency room or not; they would take me but I would need a ride home. With the pandemic and 48 new cases, I decided to stay home and I went to bed; the rash on my face was gone in the morning. The next days I just felt muscle soreness all through my body (day 2) and felt tired (next two days) but had no fever at any time. I am fine today. I appear to have two very small areas on my chest that probably related to the reaction.
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| 72 | 2021-03-12 | muscle pain |
Pfizer-BioNTech COVID-19 Vaccine EUA headache for one day muscle aches for 2 days upset stomach for ...
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Pfizer-BioNTech COVID-19 Vaccine EUA headache for one day muscle aches for 2 days upset stomach for 1-2 days
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| 72 | 2021-03-13 | arthritis |
Dose 2 Pfizer @ 10:30 AM Thursday, March 11. Event: Friday, March 12, 6:00 AM excruciating total le...
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Dose 2 Pfizer @ 10:30 AM Thursday, March 11. Event: Friday, March 12, 6:00 AM excruciating total left leg shooting pain with no relief or ability to ambulate. Saturday, March 13; friend took me to the Hospital ER upon my request. The non- stop pain was intolerable! I wanted X-Rays because I thought something somehow was broken. There was no fall or any accident of any kind. The X-Rays revealed strong arthritis & sent me home w crutches & an Ace bandage wrap. Recommended ice &/or heat, otc Tylenol or naproxen, which I did all day. Sunday, March 14, I was 80% improved. I attribute this strong reaction as triggered out of the blue by the 2nd Pfizer dose!
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| 72 | 2021-03-13 | back pain |
Chest pain (5/10), bilateral jaw numbness, left back pain, and headache. Oxygen 6 liters. Taken to t...
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Chest pain (5/10), bilateral jaw numbness, left back pain, and headache. Oxygen 6 liters. Taken to the ED>
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| 72 | 2021-03-13 | neck pain, back pain |
After first shot, pain in arm, up neck across back and into arms and fingers. Hives on the inside of...
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After first shot, pain in arm, up neck across back and into arms and fingers. Hives on the inside of upper thighs. After second shot, severe headache. I couldn't stand light for first 24 hours then continuing headache for 4 days. First 24 hours, pain in arms to fingers, neck, upperback, ache all over. Second and third day nausea.
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| 72 | 2021-03-14 | joint pain, muscle pain |
I had chills for 2 hours. headache. fever of 101.6. vomiting all over the place. I couldn't even dri...
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I had chills for 2 hours. headache. fever of 101.6. vomiting all over the place. I couldn't even drink a sip of water. cramps. leg pain. pain inbetween my shoulders. I could barely stand up, I was very weak. I went to the hospital and got a few shots to help with the vomiting. (Finigan) and medicine for the cramps and muscle aches. Fatigue and headache still lingers.
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| 72 | 2021-03-14 | joint pain |
Bedridden for 48 hours+ with overwhelming fatigue, fever, chills, severe headache, overall severe j...
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Bedridden for 48 hours+ with overwhelming fatigue, fever, chills, severe headache, overall severe joint pain, sensation of swelling in L axilla although no actual swelling noted, pain at injection site, leg cramping, mouth pain (gums & teeth)
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| 72 | 2021-03-14 | muscular weakness, muscle pain |
severe Brain fog still 5 days later dysfunctional; severe whole body muscle pain even my fingers hur...
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severe Brain fog still 5 days later dysfunctional; severe whole body muscle pain even my fingers hurt 48 hours; severe whole body muscle pain even my fingers hurt 48 hours; drooling woke me up soaked the pillows; headache worse in my life 48 hours; dropping things hands wouldn't work; vomiting; severe diarrhea still problematic; Chills/cold shaking so hard teeth chattered; Chills/cold shaking so hard teeth chattered; Chills/cold shaking so hard teeth chattered; Still can't function normally 5 days now after 2nd shot; Still stuck in the house to weak to leave; Cognitive dysfunction; could not drive; trouble speaking; pins and needles both arms and legs; ataxia; received second dose of bnt162b2 on 19Feb2021; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 72-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer) , via an unspecified route of administration on 19Feb2021 01:15 pm on left arm at single dose for covid-19 immunisation. Medical history included Known allergies: iodine dye X-rays from an unknown date and unknown if ongoing. The patient's concomitant medications were none. The patient previously took first dose of bnt162b2 (COVID 19, brand: Pfizer) on 22Jan2021 at arm at single dose for covid-19 immunization. The patient experienced cognitive dysfunction (cognitive disorder) (medically significant) on 19Feb2021 18:00 with outcome of not recovered, could not drive on 19Feb2021 18:00 with outcome of not recovered, trouble speaking on 19Feb2021 18:00 with outcome of not recovered, pins and needles both arms and legs on 19Feb2021 18:00 with outcome of not recovered, ataxia on 19Feb2021 18:00 with outcome of not recovered, severe brain fog still 5 days later dysfunctional on an unspecified date with outcome of not recovered, severe whole body muscle pain even my fingers hurt 48 hours on an unspecified date with outcome of not recovered, severe whole body muscle pain even my fingers hurt 48 hours on an unspecified date with outcome of not recovered, drooling woke me up soaked the pillows on an unspecified date with outcome of not recovered, headache worse in my life 48 hours on an unspecified date with outcome of not recovered, dropping things hands wouldn't work on an unspecified date with outcome of not recovered, vomiting on an unspecified date with outcome of not recovered, severe diarrhea still problematic on an unspecified date with outcome of not recovered, chills/cold shaking so hard teeth chattered on an unspecified date with outcome of not recovered, still can't function normally 5 days now after 2nd shot on an unspecified date with outcome of not recovered , still stuck in the house to weak to leave on an unspecified date with outcome of not recovered. No treatment received. She is not pregnant. Facility type vaccine was hospital. No other vaccine in four weeks. The patient reported that "Cognitive dysfunction, could not drive, trouble speaking, pins and needles both arms and legs, ataxia, stumbling. 72 hours of ataxia severe Brain fog still 5 days later dysfunctional severe whole body muscle pain even my fingers hurt 48 hours drooling woke me up soaked the pillows , headache worse in my life 48 hours dropping things hands wouldn't work vomiting and severe diarrhea still problematic Chills/cold shaking so hard teeth chattered Still can't function normally 5 days now after 2nd shot Still stuck in the house to weak to leave , still ataxic." No COVID prior vaccination. No COVID tested post vaccination. Information about Lot/Batch number is requested.
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| 72 | 2021-03-14 | musculoskeletal stiffness | Headache, stiff neck, weak body, fuzzy thinking, shaky, unstable walking, metal taste in mouth. |
| 72 | 2021-03-14 | muscle pain |
03.11.21 Thursday Day 1: Arm sore and swollen by bedtime, c. 2:00 am Friday. 03.12.21 Friday ...
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03.11.21 Thursday Day 1: Arm sore and swollen by bedtime, c. 2:00 am Friday. 03.12.21 Friday Day 2: Arm remains sore and more swollen than yesterday. Mild nausea all day. Moderate ?acidity? all day. Mild muscle aches all day but now seem to be lessening (8:43 pm). Started feeling unusually tired around 6 pm. 03.13.21 Saturday Day 3: Arm sore at vaccine site only. Nausea stronger. Acidity stronger ? feels like undilute sulfuric acid is burning a hole in my stomach. Extremely unpleasant. Less fatigued than yesterday. Very mild muscle aches. 03.14.21 Sunday Day 4: Nausea mild. Acidity mild. Unpleasant. More energy than any day since vaccine. 03.15.21 Monday Day 5: Very mild nausea and acidity, but still unpleasant. Slept too late but good energy level otherwise.
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| 72 | 2021-03-15 | musculoskeletal discomfort |
I am reporting the below as everything written has NEVER happened to me before in my 72 years of liv...
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I am reporting the below as everything written has NEVER happened to me before in my 72 years of living. This has all taken place since I have had the Vaccine Injection on Wednesday, February 24th. I am attributing all of this as a possible reaction to the vaccine or maybe coincidence. I wanted to report what has taken place so you all can assess if this is a possible adverse reaction, a direct effect from the vaccine or just coincidence. Please let me know if anything like this has been reported and what your thoughts about the matter. Wednesday, February 24th 11:15am Pfizer Vaccine right arm ?about an hour later discomfort on shot side that went from the shoulder up the right side of the neck. Was gone by next day. Thursday, February 25th Day seemed to be normal. When I went to bed that evening a pressure and pounding on the left top side of the head, on the part line. Lasted 5-6 hours and then went away for that episode. Friday, February 26th Day started off OK, walked 2 miles and then ran some errands. *3:00pm I bent down to pick up something and when I came up I had extreme light headedness like I have never had before. I was able to get myself collected and then continued to get ready to go out. *6:00pm I just sat in a chair in the restaurant and BAM the room started spinning at about 500 miles (that is the speed that it felt like) an hour. My arms were flailing as I was trying to grab something to old onto. Just when I was about to fall off of the chair my husband walked up and grabbed me as he could see that something was going on and he said that I was white as a sheet. Once I got somewhat collected, I knew immediately that I had to throw up. My husband took me to the restroom. I had severe dry heaves that just would not stop. I wasn?t breathing properly so my hands and feet were numb, tingly and very white in color. Then I had to have a bowel movement. We phoned for the ambulance to take me to the hospital jus to make sure that I did not have a stroke, or it was my heart, or a vessel had burst in the head. The Paramedic tested me for a stroke and I passed the test. *8:00pm or so I had another episode with room going around at top speed and I started having dry heaves. Nurse gave me medicine in the IV for nausea. My Doctor said that everything was Benign. He said that the CT patient scan was negative and all other tests were OK. Saturday, February 27th I was released from the hospital and went home. I did very little that day. I slept that night from 10:00pm until 10:00am the next day. Sunday, February 28th I was lightheaded, had a headache, and ears ringing all day. I just did not feel myself at all. Tuesday, March 9th Around noon I had a severe lightheadedness/spinning episode, eyes felt like they were spinning. Laid down for about 2 hours and when I got up I was able to function and the spinning had gotten better. Headache all night long, ears ringing, feeling of lightheadedness. Wednesday, March 10th Not quite as dizzy, headache all day, back of neck and left side of head sore to touch. Pounding on left top side of head ? along the part line, where I had the same discomfort the 2nd day after the vaccine. Thursday, March 11th Having discomfort on left side of head. To the right of the left ear, going down to the neck. I can touch those areas and add to the discomfort. Friday, March 12th On Monday, March 7th I noticed a red spot on the right side behind where I was given the injection. I tried to treat it myself but my remedies were not helping. Contacted my Dermatologist on Thursday, March 11th. She saw me today, Friday, March 12th. She is not sure if it is a possible aftermath of the vaccine or something else. Had some bloodwork run to rule how Shingles. Prescribed some medication for Shingles to take until Monday when the bloodwork report is due for review. Blood work was negative for Shingles. Ever since the episode on February 26th I have NOT felt myself at all. Lightheaded, nausea, headache, pressure in head and feels heavy, not steady on my feet, discomfort in back of head near neckline, on/off discomfort in the top of the head with a pounding force. BLOOD PRESSURE IS NOW HIGHER THAN NORMAL ESPECIALLY WITH BOTTOM NUMBER BEING HIGH. I have never had a Blood Pressure problem, although as I have aged the top number has elevated but not enough to take medicine. However, the lower number is now elevated (high 80-?s, low mid range 90?s) and Cardiologist is going to make a decision on whether I should start on a low dose medicine. I am to take my 2nd Pfizer shot tomorrow ? Wednesday, March 17th at 11:00am. Thank You for reviewing the above writings. I look forward to the conclusion VAERS makes on my situation.
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| 72 | 2021-03-15 | musculoskeletal stiffness |
On March 12, I experienced some pain in left hand. By the next day, my hand was somewhat swollen, s...
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On March 12, I experienced some pain in left hand. By the next day, my hand was somewhat swollen, stiff and I had trouble grasping items. The pain was worse on March 14, to the point that I could barely move my hand. My arm from below my elbow was also sore. I took Tylenol and, later, aspirin. My hand was swollen and the veins appeared dark through the skin. My hand felt cold and applying warm compresses helped ease the. pain. By March 15, the pain started to go away and by March 16, my hand and arm were back to normal.
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| 72 | 2021-03-15 | muscle pain |
Patient received 1st Pfizer Covid-19 Vaccine on 03/06/2021 - since receiving the vaccine patient has...
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Patient received 1st Pfizer Covid-19 Vaccine on 03/06/2021 - since receiving the vaccine patient has generalized weakness - muscles spasms and Myalgia that has not subsided since vaccine
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| 72 | 2021-03-15 | rheumatoid arthritis, joint pain |
Synovitis on right and left hand finger knuckles and wrist joints with evident damaged to the joints...
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Synovitis on right and left hand finger knuckles and wrist joints with evident damaged to the joints soft tissues with the formation of lumps the size of petit poi?s on both of the joints described above. Joint damaged evolved in a matter of four days. Tendinitis on all tendons on right and left forearms. between wrists and elbow. Excruciating pain on my hands and forearms. I have dealt with all kind of joint issues during my 15 years battle with rheumatoid arthritis but I have never seen joint damaged developed in such a short period of time. My concern is what other soft tissue in my body is being affected. ?????
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| 72 | 2021-03-16 | muscle pain |
Within 72 hours fevers, body aches, myalgia, exhaustion, poor appetite. Sx resolved after 7-10 day...
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Within 72 hours fevers, body aches, myalgia, exhaustion, poor appetite. Sx resolved after 7-10 days.
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| 72 | 2021-03-17 | joint pain |
Arm started to hurt at injection site in the evening , then feeling somewhat achy & headachy. Progr...
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Arm started to hurt at injection site in the evening , then feeling somewhat achy & headachy. Progressed to chills, body aches, fever, joint pain, and minor nausea through a good part of the night. This morning I still feel headachy and have a low fever. Have not taken any pain reducers.
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| 72 | 2021-03-17 | back pain, muscle pain |
Had muscular pain in pelvic area and in back. Had to take Tylenol for pain. Lasted all day but go...
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Had muscular pain in pelvic area and in back. Had to take Tylenol for pain. Lasted all day but gone today, Thursday March 18, 2021. I feel fine today.
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| 72 | 2021-03-17 | back pain |
Developed severe back pain. which she went to the ER to have evaluated. Upon evaluation, she was di...
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Developed severe back pain. which she went to the ER to have evaluated. Upon evaluation, she was diagnosed with a PE and blood clots in her spleen
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| 72 | 2021-03-17 | muscular weakness |
The morning following first dose I woke up with a headache, body aches, slight fever, dizzy & nausea...
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The morning following first dose I woke up with a headache, body aches, slight fever, dizzy & nausea. These went on for the next week. I didn't go into work February 26th. But did go in partial days all the next week. Very uncomfortable. The headache got worse each day until it was very bad. On March 10th I woke up with my left arm in excruciating pain and the headache. Went to urgent care and doctor gave me a shot of Tromodol. When I got to the parking lot, I became very dizzy and my legs gave out and fell in the parking lot down to t he ground. Went to ER and waited for about 3.5 hours and left and went home. Went back to ER on March 12th due to arm in constant pain. Not able to sleep or relax. Wait this time was 3 hours and I was in too much paid so my daughter took me around the corner to urgent care. I was given steroid, muscle relaxer and a cream for my arm. My left arm from muscle up to shoulder and into wrist continues to hut. Today is 3/18/2021.
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| 72 | 2021-03-17 | muscle pain |
Just lots of symptoms for 48 hours after: injection site pain, tiredness, headache, muscle aches, ch...
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Just lots of symptoms for 48 hours after: injection site pain, tiredness, headache, muscle aches, chills, nausea, feeling unwell, feeling hot (but no actual temperature). I did NOT have a severe allergic reaction, just
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| 72 | 2021-03-18 | joint pain |
headache, joint ache, low fever, chills, 17 hours later took one advil. on the third day from the va...
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headache, joint ache, low fever, chills, 17 hours later took one advil. on the third day from the vaccination I am fine.
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| 72 | 2021-03-18 | joint swelling |
Capillaries behind knees broke, and both legs, knees and feet became swollen. Her provider feels tha...
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Capillaries behind knees broke, and both legs, knees and feet became swollen. Her provider feels that it is vaccine related. He still wants pt to get second dose but moved that dose to 4/1/21
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| 72 | 2021-03-18 | muscle pain |
Pain at inoculation site at vaccination. Development severe muscle pain R arm and R shoulder within...
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Pain at inoculation site at vaccination. Development severe muscle pain R arm and R shoulder within 4 hours. Self treatment with ice pack and sleep. Pain 90% subsided within 48 hours.
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| 72 | 2021-03-18 | rheumatoid arthritis |
RA; no energy/weak; OA; coughing; chilling; diarrhea; headache; we are not hungry but food is tastel...
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RA; no energy/weak; OA; coughing; chilling; diarrhea; headache; we are not hungry but food is tasteless/no taste; fibro; no taste/food was tasteless; She did not feel very well; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for her husband and herself. This is the first of two reports for herself. Only this case is serious. A 72-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot # EN6201, via an unspecified route of administration on 10Feb2021 17:15 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included unspecified products in two weeks. There was no other vaccine in four weeks.The patient experienced coughing, weak, no taste, chilling, diarrhea, no energy, headache all on 11Feb2021. She did not feel very well on the day she took her shot on 10Feb2021 but did not have a fever. She was not hungry but food was tasteless.It was also reported that "she had RA OA and fibro. and take thyroid medicine besides medicine for the others. Adverse event start date: 11Feb2021". No treatment was received for all events and events outcome was not resolved.The patient did not have COVID prior vaccination and no COVID tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021207100 same reporter/product, similar events, different patient
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| 72 | 2021-03-19 | muscle pain, joint pain |
101 degree F fever, fatigue, headache, nausea, muscle and joint aches required bed rest and Aleve. ...
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101 degree F fever, fatigue, headache, nausea, muscle and joint aches required bed rest and Aleve. Fever down to 99 deg this morning, and symptoms resolved this morning
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| 72 | 2021-03-20 | joint pain, joint swelling |
Painful and swollen left knee; Painful and swollen left knee; Painful and swollen thigh after 24 hou...
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Painful and swollen left knee; Painful and swollen left knee; Painful and swollen thigh after 24 hours after vaccination.; In left arm pain; little swollen in 5 hours after; This is a spontaneous report from a contactable consumer or other non hcp. A 72-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot #: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 12Feb2021, the patient experienced in left arm pain, little swollen in 5 hours after, On 13Feb2021, the patient experienced painful and swollen left knee, painful and swollen thigh after 24 hours after vaccination. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of in left arm pain (pain in extremity), little swollen in 5 hours after (peripheral swelling), painful and swollen left knee (arthralgia), painful and swollen left knee (joint swelling), painful and swollen thigh after 24 hours after vaccination. (pain in extremity). The outcome of the event was not recovered.
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| 72 | 2021-03-20 | joint pain |
Patient came to the pharmacy at 1:05pm to notify us of sharp pain in the left hip bone area starting...
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Patient came to the pharmacy at 1:05pm to notify us of sharp pain in the left hip bone area starting 10 minutes after the vaccination. She was unable to get assistance at the vaccination clinic and came to pharmacy for documentation. still getting pain at the pharmacy counter.
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| 72 | 2021-03-20 | back pain |
Dry heaves, nausea, headaches, back pain. Started with dry heaves & headache on the 6th of March. ...
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Dry heaves, nausea, headaches, back pain. Started with dry heaves & headache on the 6th of March. Continued with both and added intermittent nausea. Began to have back pain during the 1st week. Unable to eat more than 1-2 bites with nausea. Took OTC pain medications. Tele-health call to PCP on 3/16/21 and obtained prescription for Zofran, which help a little. Eventually, symptoms started to subside the week of 3/24/21.
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| 72 | 2021-03-21 | arthritis |
I felt fatigue even the day of the second vaccine. Then about 2 days after I had a severe and sudde...
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I felt fatigue even the day of the second vaccine. Then about 2 days after I had a severe and sudden bout of plantar facsitis, then increase in other arthritis symptoms. Then a week after I suffered a stomach virus. Then latter that same week for two days I experienced severe right leg pain. Then developed cluster rashes on the whole right leg. Went to Urgent care since we are wintering out of state. Was diagnosed with Shingles which I have never had and hope to never have again. The blisters are improving but the pain remains. I very strongly feel this is ALL due to the second dose of this vaccine. I certainly feel the second dose of this vaccine should not be given for at least 6 months.
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| 72 | 2021-03-21 | muscle pain, joint pain | Severe headache, nausea, vomiting, muscle and joint pain, weakness, fatigue and chills |
| 72 | 2021-03-22 | joint pain |
Shaking, joint pain, fever of 101, loss of appetite, headache, tiredness, nausea, pain and redness a...
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Shaking, joint pain, fever of 101, loss of appetite, headache, tiredness, nausea, pain and redness at injection site. These symptoms persisted for 48 hours.
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| 72 | 2021-03-22 | musculoskeletal chest pain, muscular weakness |
Headache and body aches were mild. Then, began to have burning in eyelids and down side of nose star...
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Headache and body aches were mild. Then, began to have burning in eyelids and down side of nose started and continues until now. It decreased after dermatologist perscribed medication. On 3/13 went to hospital with severe chest pain. They determined it was muscular-sceletal. While in the hospital and to this day has burning in bottoms of feet. Has weakness and numbness in both legs and feet. The weakness decreases ability for activity- very uncomforatable and making her unsteady when up. She also has some weakness in her arms.
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| 72 | 2021-03-23 | joint pain | Shoulder pain |
| 72 | 2021-03-23 | muscle pain, joint pain |
I've had major aches in muscles (legs & arms) and hip joints; I've had major aches in muscles (legs ...
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I've had major aches in muscles (legs & arms) and hip joints; I've had major aches in muscles (legs & arms) and hip joints; This is a spontaneous report from a contactable consumer (the patient). This non-pregnant 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL 1283), via an unspecified route of administration, administered in the left arm on 12Jan2021 at 08:15 AM (at the age of 72 years) as a single dose for COVID-19 immunization. Medical history included Barrett's oesophagus. The patient has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported "I've had major aches in muscles (legs & arms) and hip joints on 23Jan2021. No treatment was given for the event. The clinical outcome of major aches in muscles and hip joints was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 72 | 2021-03-25 | joint pain, muscle pain |
Chills - started within an hour Sore muscles and joints - 2 hours Palpitations - 12 hours Fever - 24...
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Chills - started within an hour Sore muscles and joints - 2 hours Palpitations - 12 hours Fever - 24 hours Rash - 48 hours
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| 72 | 2021-03-25 | back pain |
Severe chest, back pain starting 1 1/2 hrs after injection, culminating in mild heart attack early W...
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Severe chest, back pain starting 1 1/2 hrs after injection, culminating in mild heart attack early Wednesday a.m.
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| 72 | 2021-03-25 | muscle pain | Headache, extreme fatigue, muscle aches, nausea |
| 72 | 2021-03-26 | bone pain |
Received second Covid shot at noon, by 5pm beet red from neck to waist, even all the way down both a...
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Received second Covid shot at noon, by 5pm beet red from neck to waist, even all the way down both arms. At 11 pm went to bed with large lump in my throat, felt like I was breathing thru a straw plus whole body freezing from inside out. Could not get warm. Added layers of clothes and blankets and laid like that all nite, no sleep. 7am called nurse, advised to remove some of the layers, drink hot liquids and Tylenol every four hours. By mid afternoon the cold was gone but severe achy bones, even the bottom of my feet hurt. Next day hot and cold and ache. Fourth day dripping sweat all day and flu like symptoms. Took three showers to get sweats down plus the entire time had been taking Tylenol every four hours. Day five just drained, felt like I'd been through the wringer.
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| 72 | 2021-03-26 | joint swelling |
Concern about unusual swelling at night in left leg and one night in which half moon shaped redness ...
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Concern about unusual swelling at night in left leg and one night in which half moon shaped redness and swelling on from of my left leg from knee to ankle.
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| 72 | 2021-03-26 | muscle pain | Brain Fog, extreme fatigue affecting my balance, muscle aches, loss of appetite, chills, fever |
| 72 | 2021-03-27 | muscle pain | Dizzy, muscular pain, fever, excessive sweating, upset stomach, feeling out of breath, fatigue |
| 72 | 2021-03-28 | joint pain, muscle pain |
Headache, muscle and joint soreness, chills, fever, fatigue, diahria, dizziness for 3 days. Experien...
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Headache, muscle and joint soreness, chills, fever, fatigue, diahria, dizziness for 3 days. Experienced constipation, headache, muscle and joint aches, chills, fever, dizziness, and worse fatigue symptoms on the 9th day. I feel that the relapse was because I did too much on the previous day. Fatigue still persists.
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| 72 | 2021-03-28 | musculoskeletal chest pain |
Dizziness. Woke up morning after and the room was moving around me. This dizziness continued off a...
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Dizziness. Woke up morning after and the room was moving around me. This dizziness continued off and on for several days. I thought it had passed and woke up today 3/29/2021 to the same dizziness and very soar ribs. Slight headache off and on.
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| 72 | 2021-03-28 | muscle pain |
I have had muscle aches and headaches for three weeks after the first shot. had blood tests which ...
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I have had muscle aches and headaches for three weeks after the first shot. had blood tests which showed inflammation and was told it was okay to have the second shot. I now have the same muscle and headaches each day, levels between 5 and 8 out of 10, and the pain fluctuates each day. This will be my fifth week of these aches. I am on medical leave from work because the headache makes it hard for me to do my job.
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| 72 | 2021-03-29 | joint swelling |
2 of My knuckles on my right hand swelled within the 1st week after the vaccine, then within 1 week ...
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2 of My knuckles on my right hand swelled within the 1st week after the vaccine, then within 1 week my baby toe on my right foot swelled Became very Red and was painful to touch and extremely painful to put a shoe on, within another week the swelling moved to my big toe on my right foot. I went to the Podiatrist on 3/29 and it appeared to the Dr as Gout, which I have never had. Blood test showed no elevated uric acid level and the Dr said it may be Covid Toe
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| 72 | 2021-03-29 | muscular weakness |
mini stroke or seizure; mini stroke or seizure; pinched nerve; left arm was weak, numb, cold; left a...
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mini stroke or seizure; mini stroke or seizure; pinched nerve; left arm was weak, numb, cold; left arm was weak, numb, cold; left arm was weak, numb, cold; a fine tremor on extension of my arm; This is a spontaneous report from a contactable other hcp (nurse and patient). A 72-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 14:45 (Batch/Lot Number: EN6198) as SINGLE DOSE (at the age of 72 years) for covid-19 immunisation. Medical history included partial seizures, autoimmune thyroiditis, eczema, osteoarthritis, asthma, irritable bowel syndrome, carpal tunnel syndrome from an unknown date and unknown if ongoing 10 years ago. The patient is not pregnant, and the patient did not have Covid prior vaccination. Concomitant medication included phenytoin (DILANTIN) taken for seizure, start and stop date were not reported; levothyroxine sodium (SYNTHROID); ergocalciferol (VIT D) and unspecified vitamin. The patient previously took amoxicillin and experienced drug hypersensitivity, erythromycin and experienced drug hypersensitivity, azithromycin and experienced drug hypersensitivity. The patient experienced mini stroke or seizure on an unspecified date with outcome of unknown, left arm was weak, numb, cold and a fine tremor on extension of arm on 03Mar2021 14:45 with outcome of recovered. On 06Mar2021, patient woke up and left arm was weak, numb, cold and she had a fine tremor on extension of arm. Symptoms resolved after 45 minutes but returned within 30 minutes and lasted another 45 minutes. No treatment was received for left arm was weak, numb, cold and she had a fine tremor on extension of arm. Patient called doctor, spoke to the advice nurse and was advised to go to the ER (emergency room) now. Patient did deep breathing and relaxation, symptoms resolved, and did not go to the ER. Instead spoke with a doctor and agreed to go to the ER if symptoms returned. Patient also had a video visit with primary doctor, and she was advised to take baby ASA. The Doctor said it could be a pinched nerve on unspecified date with outcome of unknown. Symptoms have not returned. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Mar2021. The case was reported as non-serious.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the CVA and other events. The reported events likely represent intercurrent medical conditions. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, EEG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 72 | 2021-03-30 | muscle pain, joint pain |
muscle joint aches lt arm pain at site nwollen glands neck and above clavicle nausea tired slight fe...
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muscle joint aches lt arm pain at site nwollen glands neck and above clavicle nausea tired slight fever headache
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| 72 | 2021-03-30 | muscle pain, musculoskeletal stiffness | Severe headache Muscle aches Fatigue Stiff Neck |
| 72 | 2021-04-03 | arthritis, joint pain, joint swelling |
shoulder pain lot of shoulder pain extremely harsh joint pain; swelled up; finger was very sore like...
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shoulder pain lot of shoulder pain extremely harsh joint pain; swelled up; finger was very sore like arthritis; knee weakness; This is a spontaneous report from a contactable patient. A 72 years old female patient received her first shot of the Pfizer vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 12Mar2021 as a single dose for COVID-19 immunization. Patient medical history and concomitant medication were not reported. The patient reportedly experienced ailments lot of shoulder pain extremely harsh joint pain, in her arm. Her hands swelled up a little bit, her finger was very sore like arthritis, knee weakness. Ten days after the vaccination the patient still has pain in arm and shoulders Outcome of the events weakness, arthritis and joint swelling were unknown. Information on the lot/batch number has been requested.
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| 72 | 2021-04-04 | joint pain |
Ache joints, no energy, sharp shocking pains intermittent in different areas, knees feel like knee...
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Ache joints, no energy, sharp shocking pains intermittent in different areas, knees feel like kneeling on nails...general feeling ill
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| 72 | 2021-04-04 | muscle fatigue |
muscle fatigue, nausea, vomiting, chills, mild fever lasting for about twelve hours, extreme fatigue...
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muscle fatigue, nausea, vomiting, chills, mild fever lasting for about twelve hours, extreme fatigue for two days (I assume this was a reaction since i have not been out or in contact with other people, but would side effects be that delayed?)
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| 72 | 2021-04-05 | back pain, joint pain |
Severe pain started in my back and knee on 3/11/21 and I was unable to walk properly. On 3/30/21, I...
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Severe pain started in my back and knee on 3/11/21 and I was unable to walk properly. On 3/30/21, I had a stroke. Treatment is ongoing. Outcome is TBD.
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| 72 | 2021-04-06 | muscular weakness |
1st symptom 3/19/21 at 5:30 am - Weakness in fingers on right hand. Called nurse line, they recommen...
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1st symptom 3/19/21 at 5:30 am - Weakness in fingers on right hand. Called nurse line, they recommended calling EMT. EMT said no stroke but could go to urgent care for further evaluation. Urgent care recomended ER. ER recommended appointment with Neurology 2nd symptom 3/21/21 slight droop on right side of mouth. Went to ER in Hospital. MRI revealed clot. Additional ultra sound of heart and carotid arteries clear. Final diagnosis: Subacute CVA-Lt Centrum Semiovale w/ right facial droop and right hand deficits. Recomendations: Nuerology evaluation, Outpatient PT/OT for right hamd deficits. Hospitilization: 1 day Hospital Name: Unnamed City: Unnamed State: Unnamed
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| 72 | 2021-04-07 | muscle pain |
woke up with body aches, fatigue, muscles just hurt, 2nd COVID vaccine on Tuesday. Had COVID back in...
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woke up with body aches, fatigue, muscles just hurt, 2nd COVID vaccine on Tuesday. Had COVID back in October 2020, Took 400 mg ibuprofen PTA.
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| 72 | 2021-04-18 | back pain |
Moderate bilateral pulmonary embolus - stable clinical status Patient was seen in outpatient clinic ...
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Moderate bilateral pulmonary embolus - stable clinical status Patient was seen in outpatient clinic with back pain and mild shortness of breath. She had normal vital signs. Due to history of DVT, stat CT chest was ordered. Patient was notify of result and Xarelto was started. She met criteria for outpatient treatment and will follow up in our clinic.
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| 72 | 2021-04-20 | neck pain |
pins and needles, started in my left arm, on my extremities and starting up my torso, skin felt like...
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pins and needles, started in my left arm, on my extremities and starting up my torso, skin felt like it was crawling, irregular heart beat, lowered heart rate, low blood pressure, swollen eyes, throat clamping up, pain in left ear and around left ear in the neck, headache. The tingling started in the afternoon within an hour after the vaccine, and very slowly, slowly, slowly increased the next day and in the evening it got intolerable. They put me on an IV and within minutes it all started to go away.
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| 72 | 2021-04-20 | spinal pain |
loses her voice; she just sat down in a chair, and everything went black for a second; second COVID-...
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loses her voice; she just sat down in a chair, and everything went black for a second; second COVID-19 Vaccine exasperated her spinal cord leak symptoms because her lightheadedness, and equilibrium being off, started on 25Mar2021; second COVID-19 Vaccine exasperated her spinal cord leak symptoms because her lightheadedness, and equilibrium being off, started on 25Mar2021; She hurt more, too, in her L4 & L5 vertebrae; not feeling well; body was aching/She hurt more, too, in her L4 & L5 vertebrae, and had pain throughout her whole body.; Headache; Chills; Her Oral Lichen Planus was more pronounced since her second COVID-19 Vaccine dose; Her Oral Lichen Planus was more pronounced since her second COVID-19 Vaccine dose; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 24Mar2021 13:53 (at 72-years-old) as single dose for COVID-19 immunization. Medical history included ongoing Spinal leak (Diagnosed with a spinal leak about 1-1/2 years ago. She said she has had spinal leaks, on and off, since that time.), ongoing Oral lichen planus (Stated she was diagnosed with Oral Lichen Planus between 10-15 years ago), ongoing Rheumatoid arthritis (Stated she was diagnosed with Rheumatoid Arthritis at least 3 years before she was diagnosed with Oral Lichen Planus. She said she had been tested for food allergies & as long as she stayed away from gluten, chicken, tomatoes & some other things, she did not have a problem with her rheumatoid arthritis. She said gluten, in particular, triggered her rheumatoid arthritis.), Gluten (triggered her rheumatoid arthritis), fractured her L4 vertebrae in last summer 2020, sciatica from Feb2020 (pinched sciatic nerve since Feb2020), Bone density issue. Stated her family has a history of autoimmune diseases, like Lupus. Concomitant medications included diphenhydramine, paracetamol (EXTRA STRENGTH TYLENOL PM, NDC Number: 50580-937-19, Lot Number: SLA006, Expiration Date: Aug2024); ibuprofen (ADVIL, UPC Number: 305730154604, Lot Number: EG1007, Expiration Date: Jul2023); gabapentin ("ACI Health", Expiration Date of 05Mar2022). The patient previously took first dose of bnt162b2 (Lot number: EN6198) on 02Mar2021 (at 72-years-old) Intramuscular on left arm for covid-19 immunization but experience Left arm was sore, left arm soreness went away after 2-3 days. The patient previously took Flu vaccine but experienced Mouth sores. Reported she had both COVID-19 Vaccine doses. She said she got the typical side effects of a headache, chills, not feeling well, and her body was aching. She clarified those side effects started late the night of her second COVID-19 Vaccine shot (24Mar2021). She said those side effects were mild, and resolved in about 2 days. She said she didn't think much of those side effects, until the next day (25Mar2021), when the other side effects started (blacked out, lightheaded, equilibrium was off). She said her left arm was sore after her first COVID-19 Vaccine dose. She said she didn't treat her left arm soreness, and the left arm soreness went away after 2-3 days. Reported on 25Mar2021 at about 11:30AM, she blacked out. She said she just sat down in a chair, and everything went black for a second. She said she then got really lightheaded, and her equilibrium was off. Reported she had spinal leaks, on and off, for the past 1-1/2 years. She clarified that her doctors didn't think the spinal cord leaks would be contraindicated with the COVID-19 Vaccine. She said all her doctors said it was up to her if she wanted to get the COVID-19 Vaccine because she previously had problems with the flu vaccine. She clarified she had a flu vaccine about 15 years ago, and the day after the flu vaccine, she got mouth sores, and the mouth sores got worse. She said her local doctors didn't know how to treat her mouth sores, so she went to the clinic. She said the clinic doctors told her she had Oral Lichen Planus, and the Oral Lichen Planus was caused by the flu vaccine she had received. She stated she did not have any information (NDC, Lot, & Expiration Date) for the flu vaccine she received back then. She stated she has not had a flu vaccine since that time. Reported her spinal cord leaks caused equilibrium, and lightheadedness. She said she thought her second COVID-19 Vaccine exasperated her spinal cord leak symptoms because her lightheadedness, and equilibrium being off, started on 25Mar2021 11:30. She said her lightheadedness, and equilibrium being off was still going on. Reported she hurt more, too, in her L4 & L5 vertebrae, and had pain throughout her whole body. She clarified she fractured her back (specifically her L4 vertebrae) last summer (2020), and her L4 vertebrae had since healed. She said she had a pinched sciatic nerve since Feb2020. She clarified her L4 and L5 vertebrae move because she had 3 blood patches to treat her spinal cord leaks. She said when the blood patches were done a lot of force was used to stop the spinal leaks. She said the first blood patch caused her buttocks to really hurt. She said she had 2 more blood patches. She said she was not too sure about second blood patch, but with the 3rd blood patch, she was miserable. She said she had physical therapy weekly, and she may have to have her back fused. She said she had a bone density issue that apparently was mentioned in her medical records when she was in her 50s. She said she was never treated for her bone density issue until after she fractured her L4 vertebrae in 2020. No further details provided. Reported her last blood work was 3-4 months ago. No further details provided. Reported her Oral Lichen Planus was more pronounced since her second COVID-19 Vaccine dose (Mar2021). She clarified she started to get Oral Lichen Planus mouth sores a couple days after she received her second COVID-19 Vaccine. She said she can go months without having any issues, and then get the Oral Lichen Planus mouth sores. She said she took medication to manage her Oral Lichen Planus. She said with the medication, the Oral Lichen Planus mouth sores are gone within 24-48 hours. She said with her latest Oral Lichen Planus mouth sores, she put her medication on the mouth sores, and the mouth sores seemed to settle down, but the mouth sores didn't go away completely. She said the day before yesterday (03Apr2021), her Oral Lichen Planus mouth sores got worse again, and are staying that way, even with using the medication. Oral Lichen Planus Treatment: Stated she was applying Clobetasol Propionate Ointment UPS 0.05% to her mouth sores after she eats, or about 3-4 times a day. NDC Number: 51672-1259-6, Lot Number: 332450, Expiration Date: Aug2021. For other treatment she had medication she takes every day, and she continued to take the medication to help her symptoms. She said she had physical therapy twice a week for about 1-1/2 hours, as well as, doing physical therapy on her own. She clarified she does the physical therapy for her sciatica and vestibular issues, saying she was not steady on your feet. She said she does physical therapy about 4 hours a week. Reported her doctors told her she would not survive the Corona Virus if she were to get it because of her underlying health issues. No further details provided. Reported her doctors said there was no information reporting that the COVID-19 Vaccine was contraindicated in people with spinal cord leaks, and how the COVID-19 Vaccine would affect people with spinal cord leaks. She said she thought she may have been fighting things because the COVID-19 Vaccine was acting like the flu vaccine (when she first developed Oral Lichen Planus). She said she thought her symptoms after her second COVID-19 Vaccine dose may have had something to do with her spinal cord leak because she had similar symptoms (lightheadedness & equilibrium issues) with her spinal cord leak. She said with her spinal cord leak, she also had pain and loses her voice. No further details provided. The outcome of the events she just sat down in a chair, and everything went black for a second was recovered on 25Mar2021; headache was recovered in Mar2021; chills was recovered in Mar2021; not feeling well was recovered in Mar2021; body was aching/she hurt more, too, in her l4 & l5 vertebrae, and had pain throughout her whole body was recovered in Mar2021; loses her voice was unknown; while for other events was not recovered.
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| 72 | 2021-04-24 | weight decreased |
Vomiting; Diarrhea; lost alot of weight; diverticulitis; brain fog, can't think clearly; stomach pai...
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Vomiting; Diarrhea; lost alot of weight; diverticulitis; brain fog, can't think clearly; stomach pains; violently ill; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient' medical history and concomitant medications were not reported. The patient experienced vomiting and diarrhea. Mostly diarrhea. The vomiting started 05Mar2021 in the middle of the night. She was vomiting so much she went to the Emergency room by ambulance. They kept her in the hospital for a couple of days, but she did not have diarrhea at this time. It was like three days later that she suddenly became violently ill. At the time she did not tie it to the vaccine administration, she thought she had food poisoning or something. She then had severe diarrhea. She cannot recall the exact onset date of when the diarrhea began. She can't get the dates together because she knows she became very sick. Patient recalls that when she got out of the hospital, she was having stomach pains. The stomach pains were feeling more severe on 18Mar2021. On 19Mar2021, she went to a check up with her gynecologist for an annual check up and did tell her gynecologist about the stomach pain and having a lot of stomach issues, but the doctor had no idea about it, she's a gynecologist. The patient's gastroenterologist thought maybe she had diverticulitis not related to the Pfizer COVID-19 vaccine and on 27Mar2021, they started her on Cipro and Flagyl, but the diarrhea just kept getting worse even with the meds and its just been getting worse and worse and worse. Cipro and Flagyl were stopped after 5 days because her gastroenterologist told her that maybe all of her flora was cleared out, and the flora was causing the diarrhea. No one knows what was causing her diarrhea. Oddly enough, she was feeling a little better today. She feels like she doesn't have diarrhea today, but she doesn't know because sometimes she has diarrhea for a couple of hours and then she feels just fine for a couple of hours. She also has brain fog. She was feeling like she could not think straight. She confirmed she does not have this feeling today. It got really bad after the second shot. The brain fog started between the time of first and second shot, when she had the diarrhea. It was like a week to ten days after the first shot, but she does not know exactly when brain fog started. It comes and goes, doesn't have it right now, and didn't have it yesterday. She stated that the brain fog seems to have gone away about 5 days ago. She had all these blood tests and cat scan and they all came back negative that she is in perfect health. She has no other issue except this constant diarrhea. Caller states she doesn't have any issues with any of her abdominal organs, her gall bladder and intestines are all fine. She has lost 5 pounds explaining that a month ago she weighed 136 pounds and now she weighs 130 pounds. The diarrhea is without any known medical known ideology and is very debilitating because she has lost a lot of weight. The outcome of events was reported as "unknown". Follow-up attempts are completed. The following information on the batch number has been requested.
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| 72 | 2021-04-27 | muscular weakness |
I am 72 year old female obesity, arthritis, diabetes, cancer survivor. I received Pfizer second dose...
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I am 72 year old female obesity, arthritis, diabetes, cancer survivor. I received Pfizer second dose and had the following side effects. Day of vaccine and day after, slept through for 48 hours. Day four I felt off, a bit dizzy. Day five my lower joints were weak, had trouble walking. Also at this time I experienced severe brain fog, everything was "graved out." It felt like I was drugged. I fell down and couldn't get up. EMT called to get me up. Still felt gray and wobbly so went back to bed. It took 10 days for all symptoms to resolve. The persistent sensation of being drugged was unique.
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| 72 | 2021-04-27 | muscular weakness | Lower extremity weakness - possible Guillain Barre |
| 72 | 2021-04-30 | arthritis |
hip and knee started getting more sore, difficulty walking and Limping (Arthritis aggravated); This ...
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hip and knee started getting more sore, difficulty walking and Limping (Arthritis aggravated); This is a spontaneous report received from a contactable consumer (patient), who is a retired Registered Nurse. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6203) via an unspecified route of administration in the left arm on 21Mar2021 (at the age of 72-year-old) about 11:00 as a single dose for COVID-19 immunization. Medical history included patient was diagnosed with arthritis in knee initially back in 1996 when had an injury. Patient was on treadmill and didn't warm up properly and had a torn posterior horn of meniscus in right knee. A knee arthroscopy found patient had torn the posterior horn of meniscus and found arthritis. Patient reports her hip and back arthritis have been since 2015/2016 when Patient had bone density and that's when they picked that up and had knee arthritis for a long time. High blood pressure (diagnosed with back in 1994/1995 roughly, when 46 years old, runs in family). Patient lost weight (lost two years ago next month, lost about 38lbs), mild Asthma (asthma attack when 27 years old, diagnosed with in 1975), Reflux Disease (diagnosed about 6-8 years ago). Concomitant medications included Meloxicam medication (has taken it on 04Apr2021, 05Apr2021 and 06Apr2021) she would stop taking her Meloxicam, amlodipine besilate (NORVASC) at a dose of 10 mg daily for high blood pressure, hydrochlorothiazide HCTZ at a dose of 12.5 mg, once daily for boost the Norvasc, high blood pressure and diuretic, gives boost to high blood pressure medicine, on lowest dose), Omeprazol (PROTONIX) at a dose of 40 mg daily for Stomach (all three drugs started probably 8-10 years), famotidine (PEPCID) at a dose of 40 mg daily (at bedtime) (has only been on for three years), salbutamol (ALBUTEROL) 1-2 puffs as needed for wheezing (since 27 years old and only takes when sick, if has cold or sinus infection, if had strep throat, takes to back her up), fluticasone propionate (FLOVENT) for Asthma at a dose of 44 mcg once daily (one puff) (10-12 years). Patient prior vaccinations included a flu shot back in sept of 2020. Reports she had both Pneumonia and shingles vaccines but nothing within the four weeks of the Pfizer Covid Vaccine. Family Medical History included both the patient late mother and late grandmother had high blood pressure and mother deceased (2016) and Dad passed away in 2003. Patient reported that she was on prescription anti-inflammatory medication for a long time (Meloxicam 7.5mg twice a day, she has been on it for two or three years now) and did not took the anti-inflammatory medication for two weeks after her first dose Pfizer Covid Vaccine due to which her knee and hip are started getting more sore and had difficulty walking, limping, (reported it as probably about 3-4 days after receiving the first dose of Pfizer Covid Vaccine) and always had mild discomfort but it is tolerable and doesn't effect activities of daily living, she was able to do what she has to do. Patient was a dog walker, walking dogs, goes to the market and shopping, doesn't affect her daily activities. Patient took tylenol and one of those topical rubs(it does help, applies it to her right knee and right hip in the morning). Patient enquired whether there would be interactions with Meloxicam and the vaccine. Outcome for the event was recovering. Patient was scheduled for second dose on 11Apr2021. No follow-up attempts are needed. No further information is expected.
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| 72 | 2021-04-30 | musculoskeletal stiffness, joint swelling, joint pain |
It's hard to wash my hair and brush my teeth because my arms hurt/general 24HR a day intense pain in...
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It's hard to wash my hair and brush my teeth because my arms hurt/general 24HR a day intense pain in both arms; joint pain in elbows; acute tendinitis in both arms; she can't straighten her arms out completely, she can't bend them completely/stiff; tennis elbow/golf elbow; right wrist and elbow are swollen up twice their normal size; left arm swelling; It's hard to wash my hair and brush my teeth because my arms hurt/general 24HR a day intense pain in both arms; This is a spontaneous report from a contactable consumer(patient). A 73-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, on 29Jan2021 (Lot Number: EN5318) at age of 72-year-old at SINGLE DOSE in Arm Right for covid-19 immunisation. Medical history included atrial fibrillation, hypertension from 2010 and ongoing. The patient's concomitant medications were not reported. She was taking her regular prescribed medications which are primary for atrial fibrillation and hypertension, however she has been on these medications for years.The patient previously received first dose of bnt162b2 on 8Jan2021 (Lot Number: EL3246) as SINGLE DOSE in Left arm for covid-19 immunisation. 8 or 9 days later after she received the first dose, she broke out in rash on her upper left chest and shoulder area. It spread, and she then had a patch in the small of her back and then, her legs from her knees to ankles broke out. She reports that after her 1st vaccination she developed a rash 1 week after the injection. Explaining that its a "strange rash some of which I still have on my chest, the small of my back and from my knees to my ankles", The "ones on my legs have never really resolved, its pretty ugly and the dermatologist said it looks like eczema". The doctor gave her some topical steroid cream "Mometaesone" for all of these areas. However, her legs are still not cleared up. She still has lesions there. It looks and is like eczema, but the eczema treatments are not working. For some reason instead of staying as little bumps, the bumps developed into some large, scaly patches. It's those scaly patches that are red and nasty looking which is what the dermatologist has been treating. She was also prescribed Ammonium Lactate lotion which kind of helps with the scaliness that the area produces. The patient received both doses of the COVID vaccine. Both shots were given around 1-2pm. The reaction to the second dose is far more troubling and problematic in all sorts of ways than the first dose. About 7 or 8 days after the second shot, she began to have joint pain in her elbows. She was told she has acute tendinitis and was given oral steroids to take and she was sent to physical therapy. She has had general 24HR a day intense pain in both arms. It's to the point she can't straighten her arms out completely, she can't bend them completely, especially early in the morning when she first wakes up and everything is kind of stiff. She can't even brush her teeth without having to prop her elbow on the edge of the sink. She can't brush her hair, wash her hair without pain. She has to get her partner to undo her bra because she can't. She was given a Medrol pack. With the second one, "My elbows began to hurt, ortho did x-rays and said nothing was wrong with them, and that it may be tendonitis. PT who is a hand and extremity therapist said my swelling is strange and asked if I had Rheumatoid problems. She states she has to go back to dermatologist next week for them to look at the area again. In the mean time, she has taken oral steroids and topical steroids and not much has done any good. She has had reactions autoimmune disorders to both of her vaccinations, the reactions began about a week after getting vaccinated. It was stated that these symptoms are better than dying of COVID but its very unpleasant. She has had X-rays done but it showed there was nothing wrong with her joints. No one has done any blood test. The orthopedic people took X-rays because she told them her elbow hurts. She was told that there was nothing wrong with her elbows, but she does have all this other stuff going on. She clarifies she has tendonitis, tennis elbow, golf elbow- but the hasn't had anything to cause this, and she was told they are really, really bad. Her right wrist is swollen up twice its normal size as is her right elbow. It has been going on now since February, March, April. Her left arm is doing a little bit better but her right arm is pretty acute. She confirms this swelling is still ongoing and persisting in her right arm. The AEs require a visit to Physician Office. Prior Vaccinations (within 4 weeks) was None. AE following prior vaccinations was No. She mentions she was in the military and she received many vaccines from cholera to small pox and beyond. She never had a reaction. The outcome of Joint swelling was not recovered, of left arm swelling was recovering, of other events were unknown. No follow-up attempts needed. No further information expected.
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| 72 | 2021-05-10 | joint pain, muscle pain |
Tiredness; Headache; Muscle pain; Joint pain; Chills; Fever; Feeling unwell; Cough; loss of appetite...
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Tiredness; Headache; Muscle pain; Joint pain; Chills; Fever; Feeling unwell; Cough; loss of appetite; Cataract; 'started feeling really ill'; painful injection site; A 72-years-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9265, Expiration date: unknown), via an unspecified route of administration on 28Jan2021 in left arm at a single dose for covid-19 immunization. The patient's medical history included asthma, nerve injury, chronic nerve damage and blood pressure measurement. Patients concomitant medications included losartan for blood pressure abnormal at the dose of 100 mg per day, atenolol for blood pressure abnormal, albuterol (SALBUTAMOL)) for asthma at the dose of 1.25mg, esomeprazole sodium (NEXIUM) for gastroesophageal reflux disease. On 02Feb2021, she had a cataract implant on the right side. Which was the side her headaches were on. She didn't know if it was from the vaccine or not. Five days later after surgery, on an unspecified date in Feb2021, the patient experienced started feeling really ill. She was pending a procedure on her other eye as well. She got lots of symptoms. The patient experienced tiredness, headache muscle and joint pain, chills, fever, her injection site was painful, and she was feeling unwell. The patient underwent lab tests and procedures which included body temperature which was 101.2. A couple of days after the vaccine she felt well. On 05Feb2021, then all the sudden she just felt tired and couldn't do anything. She was laying and sitting all day. She had no appetite. It had persisted. She didn't have an appetite when she eats. She couldn't taste the food. She didn't feel as bad. She could feel herself getting better. She was taking more vitamin c and more vitamins. On same date, she had a cough. She had been taking Theraflu and lung support for her chest since she developed the cough. She had fever and which was up to 101.2. It kept fluctuating. This morning it was 96. She had muscle and joint every day, but this was triple the pain of her normal pain. She had been drinking a Gatorade. She took nexium for acid reflux, and she had been taking that for a while. That was why she thinks she couldn't taste as much. She got the vaccine because with everything going on, it was the right thing to do. The reporter assessed cataract as medically significant. The outcome of events tiredness, headache, muscle pain, joint pain, fever, feeling unwell was recovering, while chills, painful injection site were recovered, cough and loss of appetite were not recovered and the outcome of started feeling really ill was unknown. She was scheduled for her second dose on 18Feb2021.
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| 72 | 2021-05-13 | joint pain, back pain |
Pericarditis; Pneumonia; Tachycardia; Headache; Achy; Fatigue; Heart rate was higher; Pain in my bac...
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Pericarditis; Pneumonia; Tachycardia; Headache; Achy; Fatigue; Heart rate was higher; Pain in my back, in my shoulder; I was very ill, I was unable to do anything; Pain in my back, in my shoulder; pain in my chest; Sed Rate was 48; by 04Feb2021 and 10Mar2021 my White blood count went down from 16,600 to 11,400; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 72-years-old via an unspecified route of administration administered in arm left on 27Jan2021 (Batch/Lot Number: Unknown) as 1st dose, single for covid-19 immunisation. Medical history included hypertension (blood pressure high) from an unknown date and unknown if ongoing, pacemaker from an unknown date. Concomitant medication included a 10 mg high blood pressure pill (unspecified). The patient reported that after her COVID shot on 27Jan2021, she had the headache, achy, fatigue on unspecified dates; but she know that her heart rate was higher, she was exercising. It was higher than it normally was and her pacemaker, she have a pacemaker and she happen to have a pacemaker check 4 days after her COVID shot which they monitor every 7 months and it was working and it was pacing 100 percent of the time which was much higher than it had been before and the week after the shot she started having pain in her back, in her shoulder and it was hard to breathe, it's hard when she breathe and by the next day she ended up in the emergency room where she was diagnosed with pneumonia, tachycardia and pericarditis all on unspecified dates. She further reported that she was still suffering from them. She have some other tests on the 04Feb2021in the ER, her hemoglobin was 14.6 and on 10Mar2021 it was 11.6 so, it gone down 3 points, by 04Feb2021 and 10Mar2021, her White blood count went down from 16,600 to 11,400 and her Sed rate count (ESR or sed rate) was 48 (clarification unknown). She was very glad that she had the vaccination and was not sad that she had it but she was very ill, she was unable to do anything but lie around for about 25 days from 27Jan2021 to 25Mar2021 so for 2 months, and she still have pain in her chest not as bad as she had, it's not like intense with every single breathe, it's only if she take deep breath. She had the second shot of the vaccine on 17Feb2021 and got sicker faster after the second shot. The patient underwent lab tests and procedures which included haemoglobin: 14.6 on 04Feb2021, haemoglobin: 11.6 on 10Mar2021, red blood cell sedimentation rate: 48 on an unspecified date, white blood cell count: 16,600 on 04Feb2021, white blood cell count: 11,400 on 10Mar2021 and heart rate: higher on an unspecified date. Therapeutic measures were taken which included treatment with prednisone, flecainide, antibiotic for pneumonia and some kind of morphine pill for pain (given in the emergency room). On 24Mar2021, she had a cardioversion to try to deal with the tachycardia and in order to do that she had to take Eliquis. The outcome of erythrocyte sedimentation rate increased and white blood cell high was unknown and for the other events was not recovered. Information on Batch number/Lot number has been requested.
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| 72 | 2021-05-16 | back pain |
Death ABDOMINAL PAIN BACK PAIN J18.9, J91.8 - Pleural effusion associated with pulmonary infection E...
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Death ABDOMINAL PAIN BACK PAIN J18.9, J91.8 - Pleural effusion associated with pulmonary infection E87.1 - Hyponatremia N13.2 - Hydronephrosis with renal and ureteral calculous obstruction C79.9 - Metastatic disease (CMS/HCC)
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| 73 | 2021-01-05 | facial discomfort |
The patient completed her 15 minute observation with no post injection reaction. At 1:15 pm, the pat...
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The patient completed her 15 minute observation with no post injection reaction. At 1:15 pm, the patient called complaining of right eye drooping, right facial tingling, mild shortness of breath, facial flushing and new onset headache. She arrived at ED at 2:06 pm presenting with facial swelling, tingling and shortness of breath. At that time, she stated her shortness of breath had actually improved and stated "probably just nerves". She still had a funny sensation in her face. She denied any focal numbness or weakness in her extremities. She stated she felt a little lightheaded. She had no sensation of throat swelling, difficulty swallowing. Physical Exam in ED: Constitutional: She appears well-developed and well-nourished. HENT: Head: Normocephalic and atraumatic. Eyes: EOM are normal. Neck: Normal range of motion. Cardiovascular: Normal rate and regular rhythm. Pulmonary/Chest: Breath sounds normal. No respiratory distress. Abdominal: Soft. There is no abdominal tenderness. Musculoskeletal: Normal range of motion. Neurological: She is alert and oriented to person, place, and time. Patient has symmetric facial numbness, she has right periorbital swelling causing what appears to be a facial droop however her mouth seems symmetric, she has negative Romberg's, she has full strength and symmetric sensation throughout Skin: Skin is warm and dry. Psychiatric: She has a normal mood and affect.
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| 73 | 2021-01-08 | muscle pain | Headache, Myalgia, Fever, NauseaVomiting, Chills Narrative: |
| 73 | 2021-01-17 | musculoskeletal stiffness, arthritis |
She has one big toe that is arthritic and it does not seem to want to bend; More like her balance do...
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She has one big toe that is arthritic and it does not seem to want to bend; More like her balance does not feel right/Still feels a little off kilter; Dizziness; Hard time focusing her sight; Neck and toe stiffness; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 06Jan2021 around 13:00-14:00 at single dose for covid-19 immunization. There were no medical history or concomitant medications. The patient got the vaccine this week on 06Jan2021 right after lunch/early afternoon. She had no issues. In the afternoon of 07Jan2021, she started getting a little dizzy and had a hard time focusing her sight. The patient also had neck and toe stiffness on 07Jan2021. She did not think about the vaccine until last evening of 07Jan2021. The hospital called to see how she was doing, and then it dawned on her. After, she took her blood pressure which was 126/68 with 81 pulse. She slept well last night of 07Jan2021. This morning on 08Jan2021 she had breakfast but still felt a little off kilter. It is like dizziness, not really dizzy, but more like her balance does not feel right. She was focusing better on 08Jan2021, but not like normal. The dizziness hit her on 07Jan2021 about 15:00. It had improved. She felt more at the time of the report, not really dizzy, but more like her balance did not feel right. It was earlier on 07Jan2021 around 14:00 she was on the ladder taking down her Christmas bows. She had no dizziness whatsoever. For neck and toes stiffness, she had one big toe that was arthritic and it did not seem to want to bend. She had been doing neck exercises which had helped. The outcome of dizziness, hard time focusing her sight, neck and toe stiffness were resolving, outcome of rest events were unknown. Information on the lot/batch number has been requested.
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| 73 | 2021-01-19 | back pain |
Fatigue, generalized aching, Mild- moderate right side sore throat and slight soreness back and swel...
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Fatigue, generalized aching, Mild- moderate right side sore throat and slight soreness back and swelling back of roof of mouth and tenderness neck glands unilaterally. Difficult/painfulswallowing -takes considerable effort to swallow.
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| 73 | 2021-01-21 | joint pain | Right arm (injection site) pain, joint pain |
| 73 | 2021-01-22 | muscle pain |
Started feeling fatigued day of shot. Next morning very tired and throughout day, slightly aching mu...
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Started feeling fatigued day of shot. Next morning very tired and throughout day, slightly aching muscles all day as well. No other symptoms.
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| 73 | 2021-01-23 | joint pain | Itching Pain in elbows, shoulders & knees Pain in stomach (not upset) Vertigo |
| 73 | 2021-01-25 | joint pain |
Headache Fever Body Aches pain in fingers and toes and knees outside of throat felt achy and sharp ...
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Headache Fever Body Aches pain in fingers and toes and knees outside of throat felt achy and sharp pain pain in eyes hoarse throat
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| 73 | 2021-01-27 | joint pain, muscle pain |
Started with join pain for a few days, started taking one Aleve a day. The muscles became extremely ...
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Started with join pain for a few days, started taking one Aleve a day. The muscles became extremely sore. Joint pain increased, involving shoulders, hands, legs, arms, knees and hips. Left hand began swelling on January 23rd and continued so I could no longer see my knuckles and it ballooned and it was hot and very painful. The knees were so bad it was almost impossible to stand from a sitting position and walking was stiff. Could not sleep laying down because pain in shoulders and knees would increase. I went to the doctor on the 26th. he prescribed Prednisolone for one week and I am scheduled to see him next Tuesday February 2nd.
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| 73 | 2021-01-27 | muscular weakness |
Nausea and vomiting beginning 12 hours after injection, headache, muscle weakness, painful injection...
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Nausea and vomiting beginning 12 hours after injection, headache, muscle weakness, painful injection site
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| 73 | 2021-01-28 | joint pain |
Aching joints of the wrists, knees and ankles. Fever, chills and dull headache. Fatigue. By the seco...
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Aching joints of the wrists, knees and ankles. Fever, chills and dull headache. Fatigue. By the second day, symptoms had disappeared and I felt fine! Temperature was normal, just slight fatigue.
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| 73 | 2021-01-29 | muscle pain |
Site soreness. 24 hours had sharp pain in left chest muscle.lastef over an hour. Hurt to take deep b...
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Site soreness. 24 hours had sharp pain in left chest muscle.lastef over an hour. Hurt to take deep breaths. Them couldn't get warm. Shivering. Felt fevered but no elevated temp registered. Lasted about another hour. Tired/weak after. Noal next day.
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| 73 | 2021-01-30 | joint pain |
pain in joints, chills, lasting 8 hrs, i took advil exhaustion lasted thru the day and part of the n...
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pain in joints, chills, lasting 8 hrs, i took advil exhaustion lasted thru the day and part of the next.
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| 73 | 2021-02-01 | muscle pain |
bad headache; a lot of muscle aches and pain; body aches from her toes to top of her head; arthritis...
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bad headache; a lot of muscle aches and pain; body aches from her toes to top of her head; arthritis that was acting up because it was cold; arthritis that was acting up because it was cold; chest hurts, left center of chest sharp pains; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via intramuscular route of administration on 13Jan2021 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included blood pressure and arthritis. Concomitant medications included unspecified blood pressure medications and some "probiotic type thing". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021, Thursday night, the patient had a lot of muscle aches and pain and has body aches from her toes to top of her head which were persisting. She thought it might be her arthritis that was acting up because it was cold but states it is more than that. Her chest also hurts, not constantly, towards the left center of her chest, what were like sharp pains but it was not normal. She is still having the chest pain, states it is not anything she can clock by time, it goes and comes back, only lasts a very short time, it hurts about a minute or two and then goes away. Last night (18Jan2021), she also developed a bad headache that went away when she slept but now that she is awake it is coming back. At the time of report, the outcome of the events not recovered. Information about lot/batch has been requested.
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| 73 | 2021-02-02 | rheumatoid arthritis |
O2 sat 70% on RA; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2...
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O2 sat 70% on RA; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; 7 days after getting vaccine patient developed shortness of breath and fatigue, O2 sat 70% on RA, now intubated and in multiorgan failure; This is a spontaneous report from a contactable physician. A 73-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose intramuscular on 03Jan2021 for Covid-19 immunisation, administered at nursing home/senior living facility. Medical history included alcohol use, diverticulitis, iron deficiency anaemia (IDA), asthma, hypertension, anxiety, recent C. diff infection, allergies to penicillin. She was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication included apixaban (APIXABAN), bioflavonoids nos, calcium ascorbate, hesperidin, rutoside, sodium ascorbate, zinc amino acid chelate (VITAMIN C [BIOFLAVONOIDS NOS;CALCIUM ASCORBATE;HESPERIDIN;RUTOSIDE;SODIUM ASCORBATE;ZINC AMINO ACID CHELATE]), cyanocobalamin (B-12), furosemide (LASIX), simethicone (manufacturer unknown), tramadol (manufacturer unknown), vancomycin (manufacturer unknown) oral, omeprazole (PROTONIX), amlodipine (manufacturer unknown), vitamins nos (MULTIVITAMIN), thiamine (manufacturer unknown), aripiprazole (ABILIFY), atorvastatin calcium (LIPITOR), clonazepam (KLONOPIN), folic acid (manufacturer unknown), sertraline hydrochloride (ZOLOFT). The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 10Jan2021, 7 days after getting vaccine, the patient developed shortness of breath and fatigue, rheumatoid arthritis, O2 sat 70% on RA, now intubated and in multiorgan failure. The events resulted in Emergency room/department or urgent care, hospitalization, life threatening illness for immediate risk of death from the event. The patient was hospitalized for the events for 18 days. Patient received treatment with corticosteroids, antibiotics, antifungals, dialysis, mechanical ventilation, inhaled Epoprostinol. The patient underwent lab tests and procedures which included SARS-CoV-2 test: unknown in Jan2021. Pre / post vaccination, the patient has been tested for COVID-19 with unknown result. The with outcome of events was not recovered.; Sender's Comments: Based on the temporal gap between the vaccination and the event onset, the Company considered that there was not a reasonable possibility that the events were related to suspect vaccine BNT162B2. The patient's advanced age, underlying medical conditions and multiple concomitant medications could be contributory to the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 73 | 2021-02-03 | muscular weakness | Chest tightness/heaviness, fatigue, "rubber arms", temp 100.6, |
| 73 | 2021-02-04 | joint pain | Sinus headache, nausea, joint pain |
| 73 | 2021-02-07 | joint pain, muscle pain | Headache, muscle ache, joint ache, raised heart rate, difficulty breathing |
| 73 | 2021-02-07 | joint pain |
Caller reports worsening hip and leg pain/her hips and legs feel real achy, she has achiness in her ...
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Caller reports worsening hip and leg pain/her hips and legs feel real achy, she has achiness in her hips and legs; Caller reports worsening hip and leg pain/her hips and legs feel real achy, she has achiness in her hips and legs; her arm was sore yesterday but better today/her arm was sore; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3247), via an unspecified route of administration in left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing 'sometimes her hip and leg would hurt prior to getting the vaccine'. There were no concomitant medications. Caller received the covid shot on Wednesday, 20Jan2021, her arm was sore yesterday (21Jan2021) but better today (22Jan2021). Caller reports worsening hip and leg pain on 22Jan2021 because sometimes her hip and leg would hurt prior to getting the vaccine. Caller would like to know if it's okay to have taken Tylenol for her symptoms after taking the covid vaccine. Response: The interim ACIP guidelines note that, "Antipyretic or analgesic medications (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) may be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms is not currently recommended, as information on the impact of such use on Pfizer-BioNTech COVID-19 vaccine-induced antibody responses is not available at this time.& quot; If you are a patient, you should discuss this with your healthcare provider. Caller would like to know how long the symptoms from the covid vaccine would last. Calling about the Pfizer COVID vaccine she took it on Wednesday (20Jan2021), the Pfizer Biontech, and yesterday (21Jan2021) her arm was sore all day, which is probably to be expected, but today (22Jan2021), she has, her hips and legs feel real achy, she has achiness in her hips and legs, it was asked if that is normal. it was asked if it is a side effect from the shot. Her arm is not like it was yesterday (21Jan2021) if the achiness was a side effect, she thought she may have had it yesterday (21Jan2021), but she didn't, just today (22Jan2021). The outcome her arm was sore yesterday but better today/her arm was sore was recovering. The outcome of other events was not recovered.
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| 73 | 2021-02-07 | musculoskeletal stiffness |
Within a few minutes after receiving the vaccine my arm felt stiff and some soreness. Then it fine a...
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Within a few minutes after receiving the vaccine my arm felt stiff and some soreness. Then it fine after I got home and I moved my arm around. It was fine by the next day. Yesterday I ate some shrimp and within the hour of eating the shrimp, I was talking to my son and my head got hot and my ears got really hot. It was itching on my forehead and the front of my neck. I thought something bite me, I went to bathroom. I had big welts on my neck about the size of the quarter and my ears were really red. I told my son that I must have hives, my son told me to take some Benadryl. It eased up after taking the Benadryl, the itching went away but the welts did not go away right away. I took another Benadryl before I went to bed last night. I was able to sleep good last night, it looked pretty much back to normal today, there is one spot left. Today when I got up I don't know how to explain it and I just didn't feel like my normal self. I felt like nervous and shaking. I didn't feel like eating but I made my self eat. I just feel like something isn't right.
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| 73 | 2021-02-08 | back pain |
Two days after receiving the vaccine, on Jan 28th, I noticed pain in my right lower back area. It ...
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Two days after receiving the vaccine, on Jan 28th, I noticed pain in my right lower back area. It went away so I didn?t pay much attention to it. On Jan 29th, I woke up to stabbing pains in my right chest which continued to night of Jan 30th. Morning of Jan 31st, I was very short of breath and could hardly get around. I went to the ER in evening of Jan 31st. I was admitted due to two pulmonary embolisms in my lungs. Doctors were convinced I had Covid 19. However, three tests came up negative. I was put on a Heparin drip and then eventually on Eliquis. I have always been healthy up to this point and never had any clotting issues. I now am on Eliquis for at least six months (have to have a follow-on echocardiogram due to issues on right side of my heart.). I am convinced the vaccine triggered the clots.
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| 73 | 2021-02-09 | joint pain |
Itching; Pain in elbows, shoulders and knees; Pain in stomach; Vertigo; This is a spontaneous report...
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Itching; Pain in elbows, shoulders and knees; Pain in stomach; Vertigo; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, lot/batch number not provided), via an unspecified route of administration on the left arm on 22Jan2021 08:30 at SINGLE DOSE for COVID-19 immunization at the Public Health Department. Medical history reported as none. The patient's concomitant medications were not reported. On 23Jan2021 23:45, the patient experienced itching, pain in elbows, shoulders and knees; pain in stomach and vertigo. The patient was not diagnosed with COVID-19 prior and not tested since vaccination. No treatment was received for the events. The patient had not recovered from the events. Information about lot and batch number was requested.
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| 73 | 2021-02-09 | muscle pain |
12 hours after receiving vaccine, patient developed sweats, chills, temperature to 101.4, and myalgi...
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12 hours after receiving vaccine, patient developed sweats, chills, temperature to 101.4, and myalgias. Symptoms lasted 48 hours. Over last 24 hours patient has developed redness and itching over the injection site on the right arm.
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| 73 | 2021-02-09 | weight decreased, joint pain, muscle pain |
Vaccine at 12:20 pm. Side effects started out with arm pain and then chills and nausea.the same as w...
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Vaccine at 12:20 pm. Side effects started out with arm pain and then chills and nausea.the same as when had first dose. 4:30 pm -acetaminophen 500mg 10:30pm severe right arm and shoulder pain 8/10. Nausea 11:30 acetaminophen 500 mg. Was trying to not take any medication for fear it would effect negatively the vaccine efficacy. continued nausea Did not sleep first night kept waking groaning in pain/R arm shoulder 5:00 am acetaminophen 500 mg body aches and continued severe arm pain. 10:40 am acetaminophen 500 mg " and " and nausea 11:30 am severe body aches, chills and fever 99* with 500mg Acetaminophen. my Normal temp (96.8) 3:30 pm "
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| 73 | 2021-02-10 | muscular weakness |
about an hour after vaccine. First left hand weakness. Hand stopped at local grocery store on the wa...
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about an hour after vaccine. First left hand weakness. Hand stopped at local grocery store on the way home. Right hand dominant but use left hand a great deal. Dropped everything I lifted or put in my left hand. Light or heavy. Embarrassed at first, then concerned. Stopped at pharmacy to pick up unrelated med and mentioned to pharmacist. We both laughed. Returned home and told husband. It continued. Later started feeling numbness in fingers and hand on left sixths left leg and numbness and tingling up left neck and face and scalp. Lasted 30 min to an hour. Weakness in hand got better over days . Waited until recently to report it to Anyone and chose Dr as he follows me for other issues and I have a second dose due and became frightened.
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| 73 | 2021-02-10 | muscle pain, joint pain, back pain |
a sharp pain was coming from the side of my back and shooting to my left breast/ a muscle on the sid...
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a sharp pain was coming from the side of my back and shooting to my left breast/ a muscle on the side going down of my back/ sharp pain when I make a turn or reach that goes to my breast; when she moves that she has a pain that goes through the lymph nodes or muscles behind her left breast; when she moves that she has a pain that goes through the lymph nodes or muscles behind her left breast; pain was either from something in her left shoulder, or the left side of her back, or a muscle; feeling a little down and out; she can't sleep in the heat at night; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL8982 ), via an unspecified route of administration at left upper arm on 23Jan2021 16:00 at single dose for COVID-19 immunization. There were on patient medical history and concomitant medications. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks).The patient said she did good on Saturday, 23Jan2021, saying her left arm didn't get sore. She said she did good on Sunday, 24Jan2021. She stated "I didn't get sore, but it just seemed like maybe a few days ago it seemed like a sharp pain was coming from the side of my back and shooting to my left breast (on 25Jan2021). It only does it when I am lying down and not when I am sitting down. I drank plenty of water and continue to drink plenty of water. Today, I am feeling a little down and out because of my breast (25Jan2021). My breast itself is not sore at all. It seems like maybe a muscle on the side going down of my back. There is a sharp pain when I make a turn or reach that goes to my breast. Well, if you have arthritis it could be that." She said it seemed when she moves or turns, she has a sharp pain in her left breast. The patient asked if the sharp pain she was experiencing in her left breast area were possibly her lymph nodes. She clarified her left breast was not sore, but the area behind her left breast has a pain go through it. She said it was just when she moves that she has a pain that goes through the lymph nodes or muscles behind her left breast. She said she normally doesn't sleep on her left side, but if she sleeps on her left side, the pain behind her left breast was better. She said she does not have big breasts and was not wearing a bra when she had the pain in her left breast area. She said she was wondering if the pain she has is from her lymph nodes or muscles in her back. She said the pain was either from something in her left shoulder, or the left side of her back, or a muscle. As treatment, patient reported that she has been holding her left breast area when she moves. She said holding the left breast area helps lessen the pain, but the pain was still there. She said she has been trying to troubleshoot her pain. She said she drinks coffee every day and thought maybe she was drinking too much caffeine. She said she can't sleep in the heat at night, so she turns the heat off in her house at midnight, but her house was still warm (70 degrees) when she wakes up in the morning. She said she thought that maybe the cold weather got into her back and left shoulder. She said she checked her left breast for lumps and didn't find any lumps. She said the only thing left for her to do was to contact her gynecologist and go have a mammogram. She doesn't take any medicine. She said she does take something for sleep as needed, but she would have to be going without sleep for a long time before she would take that medicine. She reported she is otherwise a healthy person. She said people talk about hormones changes after when a person used to have a period, and she sometimes doesn't know if her pain would be because of that. She said she may have irritation in her breasts from wearing a bra that may be too tight, but the pain she was experiencing now was different from that pain. The events did not require a visit to Emergency Room or Physician Office. The outcome of the events she can't sleep in the heat at night and feeling a little down and out was unknown; and not recovered outcome for the other events.
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| 73 | 2021-02-10 | muscle pain | sharp pain at injection site, body and muscle aches |
| 73 | 2021-02-11 | armpit pain | Chest pain radiating to arm pits, shortness of breath, fast heart rate, fainting, loss of vision |
| 73 | 2021-02-11 | joint swelling |
beginning with itchy soles of my feet and both palms, and progressing through the day with the addit...
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beginning with itchy soles of my feet and both palms, and progressing through the day with the addition of grotesquely swollen knees and hives on legs, arms, and a few on my back. The hives presented as large welts all very itchy. I applied Calamine lotion and took a Loratadine pill, and the hives and itch subsided dramatically. I also developed flu-like symptoms of malaise and wheezing. At no time did I have a fever nor did my throat swell or close. Saturday, 24 hours after the first Loratadine pill, the hives and swelling reappeared but disappeared within 15 minutes of taking another Loratadine pill. Sunday through today, the swollen knees and wheeze remain but diminished in severity
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| 73 | 2021-02-11 | muscle pain, joint pain | Fever, muscle pain, head ache joint pain. Treated with Tylenol. |
| 73 | 2021-02-12 | joint swelling |
slight fever headache pain in arm by 4 am Feb 13, 2021: increased headache, aches and pains everywhe...
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slight fever headache pain in arm by 4 am Feb 13, 2021: increased headache, aches and pains everywhere, swollen face and joints
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| 73 | 2021-02-12 | muscle tightness |
Day 1 after vaccine administered, chills, low-grade temperature, sore arm, sweating, total exhaust...
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Day 1 after vaccine administered, chills, low-grade temperature, sore arm, sweating, total exhaustion, dry cough. Day 2 reduced but continued with chills, low-grade Temperature, sweating, exhaustion, dry cough. Day 3 much better but the cough and night sweats have continued every evening/night through Day 10. Day 11, middle of the night, sweating, chills, whole-body discomfort (not exactly aches), and pressure/tightness in middle of chest and back. Currently Day 11, chills, lower than usual temperature (97.3) and extremely tired.
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| 73 | 2021-02-13 | neck pain, bone pain |
Woke up at 3:30 am with neck hurting badly and headache. Could not go back to sleep. Got up used ...
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Woke up at 3:30 am with neck hurting badly and headache. Could not go back to sleep. Got up used heating on my neck got better. Throughout day I had chills, low grade fever, body and bone aches, no appetite , no energy. No reaction to shot site. Just sore.Stayed in bed mostly. During night I had 2 sweats that I had to get up and change clothes. Sunday morning still slugglish and no appetite. Drinking plenty and took tylenol and advil
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| 73 | 2021-02-14 | muscle pain | Chills, muscular aches, headache, slight temperature general feeling miserable |
| 73 | 2021-02-16 | joint pain, muscle pain |
Started with sinus drainage, which became constant and intermingled with blood. Arm was sore, joi...
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Started with sinus drainage, which became constant and intermingled with blood. Arm was sore, joint and muscular aches. Then progressed to persistent productive cough. No fever during this time. These symptoms lasted until 2/15/2021.
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| 73 | 2021-02-16 | joint pain, muscle pain | HA, chilly, muscle pain, joint pain, temp =100 |
| 73 | 2021-02-16 | joint pain, neck pain |
Started having neck and L shoulder pain on 2/6. Continuously got worse and on 2/12 went to PCP. Dx a...
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Started having neck and L shoulder pain on 2/6. Continuously got worse and on 2/12 went to PCP. Dx a pinched nerve. On 2/13 at 2:23pm, my whole L arm broke out in vesicles. Went to ER. Dx with Shingles. Started on Valtrex 1ooomg TID and Prednisone 50mg daily x5 days. V.esicles continued down into my L hand and fingers. Nerve pain continued to be severe. Went back to PCP on 2/16. Started on gabapentin.
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| 73 | 2021-02-16 | limb discomfort, muscle tightness |
psychedelic feeling; horrible palsy, as if her muscle was being pulled like a rubber band; horrible ...
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psychedelic feeling; horrible palsy, as if her muscle was being pulled like a rubber band; horrible palsy, as if her muscle was being pulled like a rubber band; the worse bowel movement. She had to go the bathroom a lot; Her right arm was the worse with the pain and then her hands would kind of move in a kind of crazy way where it was tightening; muscle cramping and pulling; Her toes would contort and go backwards.; she feels like the left arm is going to do something, its like the last to be pulled; shingles; muscles became tight/contort; minor nausea; Stomach cramps; Gas; Indigestion; became weird in her head, almost like a lightheadedness; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular on 30Jan2021 at 10:00 at a single dose on right arm for COVID-19 immunisation. Medical history included fever, being ill (deathly ill and it lasted for three weeks) and bug bites from an unknown date and unknown if ongoing. There were no concomitant medications. The patient is the type of person that takes a lot for her to take medications. She is allergic to a lot of things; she always has crazy reactions. She can't take morphine. It took her 7 pills to get the right one for high blood pressure. She has the craziest one-day reactions. She received the COVID-19 vaccine on Saturday much against her will, knowing she had COVID but not diagnosed in March. She had a fever, she was deathly ill and it lasted for three weeks. She had a nasal swab done and it came back negative. She doesn't think that was right, she believes she had COVID-19 in Mar2020. Her daughter is younger, and she had the same thing, she couldn't breathe good for 3 weeks. She had pneumonia. She knows she had COVID-19. She was trying to lose weight. She was given her first COVID-19 vaccine by a doctor. Everything was going okay at first. About an hour and a half later, she became weird in her head, almost like a lightheadedness. She can't describe it. She has never taken drugs. She doesn't drink alcohol at all. She has like a virgin body. She states plus she is red headed, which it is known red heads have a harder time with medication. As the day goes on, she just felt lightheaded all the rest of the day. The next day (Sunday, 31Jan2021), she wakes up and it hits her like a ton of bricks. She woke in the morning and seemed to be okay and then it was like she was pregnant and blew up. She started cramping really bad and had gas. Everybody has gas. She was a little nauseated as well. She experienced lots of indigestion, cramping in her stomach like she was going to have a baby or the worse bowel movement. She had to go the bathroom a lot. She had a little bit of nausea. She had nausea pills because she had a gallbladder taken out and she took nausea pills for 2-3 days. She didn't take any medication for any of these symptoms she started to experience on Sunday. However, she did start popping Gas-X. She was taking two Gas-X every 3 or 4 hours. The caller states it helped. She had lots of gas; gas was just coming out of her bottom. She had the gas, cramps, her stomach hurt. She was able to get through it, which that is good. Then Monday, 01Feb2021 was the day she had weird things happen to her that she was kind of concerned about. Her muscles started to draw, that is the best way she can describe it. Her feet would just draw up weird. Her arms and hands would do crazy things and contort or draw up. This hurts because the muscles are like a rubber band pulling. It was weird, and she didn't like it. It wasn't like when she has a horse and has to get up and stand, it wasn't like that at all. Her muscles were tightening up like a rubber band. Her right arm was the worse with the pain and then her hands would kind of move in a kind of crazy way where it was tightening. She thought to herself, "what is this Parkinson's?". She doesn't even know. She still has some stomach issues, but it is easing up. The gas is still coming out. It wasn't debilitating or anything. She has some minor nausea. What scared her more was the muscle cramping and pulling. Her toes would contort and go backwards. The muscle tightness occurred yesterday, 01Feb2021. It happened all day and was sporadic. Her toes moved in a different way like a rubber band pulling on muscle. Nothing has happened today. Everything was yesterday. Her whole body basically was affected, just different sections at different times. Today, she feels like the left arm is going to do something, it's like the last to be pulled. Her hands and fingers stayed the same. She explains like the upper arm area from her elbow to her shoulder part. She can't even think of what that area is, but it's the part between her elbow and shoulder. She has been doing lots of exercises and moving, hoping the part of her elbow to her should don't atrophy or won't pull. She hasn't told anybody about it. She doesn't like it. It was very frightening. She is scheduled for her second shot and she is scared to death to go back. She mentions her nerves are shot. From stress, she had previously broken out instantly. She thought it was a bug biting her. She never had gone to the doctor but after about 4 weeks, she thought she had these horrible bug bites. She was shaking her clothes and she almost wanted to strip it was so bad. She thought it was severe bug bites. She couldn't figure it out. She finally went to the doctor after a week. It was a Saturday. The doctor told her it was shingles. Explained that it itches a lot. She went on medication. She clarifies she went on acyclovir 800mg, three pills a day. She called her doctor knowing that she had shingles and how scared she is with medicine, the doctor assured her she could get the COVID-19 shot as scheduled. The medicine for shingles (acyclovir) was finished up the Friday before she received the COVID-19 vaccine. She got the shingles shot at 60 but everybody is now saying to get the new shot for shingles which she has never done obviously since she got the shingles. She plans to get the shingles shot in the summer. She is not worried about it. She took 3 pills a day and that was fine. She is fine, meaning every day she did normal things going through the whole process. She states she plans to go to the bank. She asked if anybody has reported the reaction she experienced after receiving the first dose of the Covid vaccine. She received the first dose of the vaccine last Saturday, in which within an hour and a half her "brain got weird, like a psychedelic feeling and it felt like I was getting an injection in the operating room to go to sleep." On Monday she experienced, "horrible palsy, as if her muscle was being pulled like a rubber band." Stated that it wasn't a horse feeling. Her hands and fingers would pull and contort in different positions, in which they would remain tight and stay in that position, and then she would be able to make a closed fist. On Monday night, her left arm contorted (which is not administration arm) and her muscle became really tight from her elbow to her wrist leading to her hand contorting as well. She describes the muscle tension as if a rubber band was being pulled, it would have burst. This muscle pulling hurt, in which she took 3 ibuprofen (ADVIL). She has crazy reactions with almost anything that she takes. She has never smoked or drank. The patient underwent lab tests and procedures which included COVID-19: unknown on an unspecified date and unknown on Mar2020, SARS-COV-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of gas (flatulence), muscles became tight/contort, minor nausea, horrible palsy, as if her muscle was being pulled like a rubber band and shingles. The outcome of the event 'the worse bowel movement. She had to go the bathroom a lot' was not recovered while of the rest of the events was unknown.
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| 73 | 2021-02-16 | muscular weakness |
Pt had onset of weakness in lower legs and forearms immediately following the vaccine and is very fa...
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Pt had onset of weakness in lower legs and forearms immediately following the vaccine and is very fatigued since receiving the vaccine.
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| 73 | 2021-02-16 | musculoskeletal stiffness |
Approximately 12 hours after vaccination pain and slight stiffness was noticed in the right upper ar...
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Approximately 12 hours after vaccination pain and slight stiffness was noticed in the right upper arm. No after vaccination treatment was received according to report from client. Shoulder stiffness progressed for the next 2 and 1/2 - 3 days after vaccination resulting in limited mobility, client unable to raise her arm. Client called her physician who advised her to call the HD which she did 2/16/21 at 4:50pm. Client reports having no other symptoms after vaccination and is applying (Icy Hot) patch to shoulder area which seems to be improving her mobility. she is able to raise her right arm and the soreness is improving. Client stated she would call her physician if she does not continue to improve and is agreeable to a call next week to see how she is progressing in her recovery.
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| 73 | 2021-02-17 | joint pain |
Temperate as low as 94.7, chills, stomach pain, runny nose, diarrhea, exhaustion, joint pain, headac...
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Temperate as low as 94.7, chills, stomach pain, runny nose, diarrhea, exhaustion, joint pain, headache --- still experience 4 days later
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| 73 | 2021-02-17 | joint pain | Error: Shoulder Joint Injury (prolonged pain, tingling, etc.) |
| 73 | 2021-02-17 | musculoskeletal stiffness | Headache after shot. Next day, sore, stiff arm, body aches and chills. |
| 73 | 2021-02-17 | muscle pain | Chills. Exhausted, pins and needles in legs, sore leg muscles |
| 73 | 2021-02-21 | neck pain, musculoskeletal stiffness |
This is not a critical reaction but want to report in order to help build up the information availab...
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This is not a critical reaction but want to report in order to help build up the information available to healthcare professionals going forward. Morning after chills, neck stiffness, pain back of head left side. Applied heating pad to neck. By late morning I was nauseous , and weak as a kitten. Took a 500 mg Tylenol and slept for about 4 hours. Woke up in a sweat but chills gone and am now able to eat a little bit. Back of head and neck still very sore. The injection site is sore but no rash; right arm seems to have "phantom pain" as well ( I experienced this with Shingles shot in December 2020 too).
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| 73 | 2021-02-23 | joint pain |
Feeling sick, AFIB occurrences, had a fever on 2nd day of 100.8, left shoulder hurt from shot and ju...
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Feeling sick, AFIB occurrences, had a fever on 2nd day of 100.8, left shoulder hurt from shot and just felt very bad all over!
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| 73 | 2021-02-23 | back pain, musculoskeletal stiffness |
2/6/2020 and 2/7/2020: severe chills/horrible headache--rizatriptan 2/11/2020 through 2/14/2020: sev...
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2/6/2020 and 2/7/2020: severe chills/horrible headache--rizatriptan 2/11/2020 through 2/14/2020: severe abdominal pain; low backahe; headache--aleve and rizatriptan 2/21/2020 through 2/25/2020 severe stiff neck; headache; aleve X4 pills Only a sore arm from the fist vaccine.
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| 73 | 2021-02-24 | back pain |
On Feb. 12th at 2PM symptoms started with lower back pain, pain in abdomen and stomach, cramping, ch...
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On Feb. 12th at 2PM symptoms started with lower back pain, pain in abdomen and stomach, cramping, chills, ear ache, pain level 8. Felt sick all over, like having the flu and then whole body ached, not just GI track. Left arm injection site was red, sore to touch, swollen (slightly). Doctor couldn't get vaccination needle into arm muscle the first time and so had to try a second time. Intense cramping of GI track started up again 8:45AM on Feb. 13th. By 4PM Feb. 15th fever 102F, chills, felt freezing cold and had to wrap myself in a heating blanket. Pain level 10, especially in pancreas. Fever broke around 2:30AM Feb. 16th and later when I was up at 8AM I felt very weak, faint, pancreas ached. Pancreatic pain lasted another 3 days. Pancreatic pain stayed around level 5. On Feb. 17th took ibuprophen. Pain level reduced to 1. This was the only time that I took pain medication between Feb. 10th and 17th, because I am conservative about using Ibuprophen, Tylenol, and have a high threshold for pain.
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| 73 | 2021-02-24 | joint swelling |
Tingling of fingers and numbness of left cheek. Did not get any worse after 30 minutes. Extremely t...
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Tingling of fingers and numbness of left cheek. Did not get any worse after 30 minutes. Extremely tired and sore arm that day. Day 2 - tired easily, no stamina. Dizzy and nauseous after showering at3:30 pm. By 10:30, both hands were red and itched. Sometime in the night woke with a very sharp, painful headache. Did not last. No real problem again until Saturday. Nausea at 11:20 am. Sunday I sat all day doing taxes - no symptoms noted. Monday after walking - rapid heart rate and very tired after what is normal activity. By 4:30 I was tingling all over my body. Tuesday night my ankles are swollen for the first time in years. Only happened that nigh. Wednesday morning, the tingling is very strong in my calves. and I had a sharp pain in the area of my Achilles tendon. I believe that the vaccine has exacerbated the neuropathy (undiagnosed) of the bottom of my feet. Today I am reporting because I fell for no reason getting out of a chair, and the tingling is in my legs, arms, shoulders. I had not heard until today that the vaccine could affect the nervous system. The effects are the worst they have been and it has been one week since I had the vaccine. Should I get the second shot? Due March 11,2021.
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| 73 | 2021-02-25 | joint pain, muscular weakness, musculoskeletal stiffness |
Within three hours I experienced stiffness in my left knee which escalated to incapacitating pain an...
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Within three hours I experienced stiffness in my left knee which escalated to incapacitating pain and inability to support my weight, this lasted for three days with 2nd day being the worst pain and discomfort. Also had a headache for most of the day on the second day. Four days following vaccine I started to notice the injection site was getting itchy, then on day Five it was increasing and started getting red, swollen, hot and itch increased. Day Six it is still itchy, red, hot and swollen. Red site is about the size of an orange. As of Day Six, No fever, headache or other symptoms and knee has returned to normal discomfort.
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| 73 | 2021-02-25 | joint pain, muscle pain |
Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This ...
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Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at 10:30 at single dose in right arm for COVID-19 immunisation at the age of 73-year-old. Lot number was EM9810. The patient was not pregnant at the time of vaccination. Medical history included asthma, psoriasis, psoriatic arthritis, cardiac arrhythmia. Past drug history included allergy to Tetracycline. Concomitant medications included metaprolol, montelukast sodium (SINGULAR), simethicone (PEPSID), clonixin lysinate (SKELAXIN), Vitamin D. On 04Feb2021, the patient experienced fever 101.9, severe headache, muscle aches, joint pain, weakness, brain fog, lethargy, nausea. Fever and headache continue 9 days after the injection. On 11Feb2021, Covid test at one week was negative (nasal swab). The patient was treated with Tylenol. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has been tested for COVID-19.
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| 73 | 2021-02-25 | back pain, joint pain |
ran a fever of 101 degrees; lots of chills; sweating; dizziness; she was not quite herself; aching i...
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ran a fever of 101 degrees; lots of chills; sweating; dizziness; she was not quite herself; aching in her shoulder, into her back; aching in her shoulder, into her back; weak and unable to function; weak and unable to function; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), intramuscular on 16Jan2021 1:45 PM at a single dose on the left shoulder, right at the very top for COVID-19 immunization. Medical history included ongoing lupus since 1999. Concomitant medications reported were none. The patient experienced aching in her shoulder, into her back, dizziness, she was not quite herself on 16Jan2021; she ran a fever of 101 degrees, had lots of chills and sweating on 18Jan2021; she became weak and unable to function, and tired on an unspecified date in Jan2021. The patient stated she got the first dosage of the COVID-19 vaccine and had some side effects. She received the first COVID-19 vaccine on 16Jan2021. She had some aching in her shoulder and stuff on 16Jan2021. For 2 days, she was weak and unable to function. She ran a fever of 101 degrees on 18Jan2021 and was sweating head to toe. At the time of report, she currently had no fever, but was feeling very fatigued. She stated she is trying to make her next appointment, but she can't pull up the paperwork. She wants to know what to do about the side effects. Her next appointment on 13Feb2021. Her shoulder hurt an hour after she received the vaccine on 16Jan2021. That night and the next day, the whole shoulder even into her back started hurting. Like when she rolled over and laid down, she would say "ohhh, I can't lay that way". This lasted for a couple of days. Her shoulder is still tender, but it is much better. She can lift it up, move it around and it's not causing her any difficulty. She stated she became weak. The first night after receiving the vaccine in the middle of the night, she kind of had like a dizziness, she was not quite herself. She thought it was just part of the vaccine. The next day, she couldn't do anything. She was down for 2 days after that. On the 17Jan2021 and 18Jan2021, she was feeling really happy. On 18Jan2021, she started to have a fever. She had a fever that night and part of the next day. She had lots of chills. The fever and chills have seemed to go away. She just feels really fatigued after. She woke up twice and her whole body was soaked. She states that is all gone now. She has had no fever. She had a very good night last night. She stated her aches and pains were at a minimal. She stated she is 73 years old, so she is going to have aches and pains as it is. At the time of the report, all she has is fatigue. She added that the fatigue isn't coming from her, it's from the vaccine. She was very active usually. But at the time of the call, she would get up to do a little and then she would have to sit back down. She was very tired. She was feeling weak and out of pocket. She was so tired. She didn't want to do anything. She stated she must find someone who can print her new paperwork. She plans to call her doctor and see what he thinks about her receiving the second shot. She feels she really needs to get the second shot. During the report, she made the comment "I'm sorry, I'm choking on my cough". The patient underwent COVID-19 test on 14Jan2021 with result of negative. She also underwent blood test on an unspecified date with unknown results. The reported adverse events did not require a visit to the physician office or emergency room. Outcome of the event fatigue was not recovered, while outcome of the other events was recovered on an unspecified date in Jan2021. Information on the Lot/Batch number has been requested.
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| 73 | 2021-02-26 | muscle pain, joint pain |
sore upper left arm 2 days, fatigue 5 days, muscle & joint pain 5 days, diarrhea 4th day rested a...
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sore upper left arm 2 days, fatigue 5 days, muscle & joint pain 5 days, diarrhea 4th day rested and slept for fatigue took Tylenol first 2 days, and ibuprofen thereafter for pain took bismuth subsalicylate for diarrhea
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| 73 | 2021-02-26 | muscle pain |
Slightly elevated temp, mild nausea, chills, muscle aches, fatigue, mild headache. All this started ...
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Slightly elevated temp, mild nausea, chills, muscle aches, fatigue, mild headache. All this started 6 days after the vaccine. On the 6th night after the shot, symptoms lasted about 8 hours. Then started up worse during the night of the 7th day, especially the chills, elevated temp, fatigue and nausea. Symptoms such as the chills are starting to subside about 10 hours later but some such as mild fatigue still remain. Is this normal for symptoms to show up nearly a week after the shot?
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| 73 | 2021-02-26 | neck pain |
Worsening of neuropathy symptoms: burning in hands, feet, new symptoms: transient burning in other p...
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Worsening of neuropathy symptoms: burning in hands, feet, new symptoms: transient burning in other parts of my body, bad tinnitus in left ear, worsening of chronic neck pain , worsening of dry eye syndrome.
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| 73 | 2021-02-27 | muscle pain |
Fever, chills, muscular aches, nausea...approx. 14 hrs. after injection...had a "tin" taste immediat...
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Fever, chills, muscular aches, nausea...approx. 14 hrs. after injection...had a "tin" taste immediately after the injection, lasting about 15 minutes
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| 73 | 2021-02-28 | joint pain |
Woke up at 2:30 AM,2/25, with chills and just didn't feel good,a little ache. Could not sleep becaus...
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Woke up at 2:30 AM,2/25, with chills and just didn't feel good,a little ache. Could not sleep because I was just uncomfortable all over. Felt a little light headed. At 7:00 took temp,99.2,- my normal is around 97.7. Right arm was feverish and extremely sore,more so than first vaccine. All that day fever went up to 101.2 by the afternoon. Drank liquids all day. had a headache most of the day with all over joint pain. Never had the flu but think this must be how you feel. Fever broke around 3:00AM on 2/26. Upper arm remains sore, swollen,red and feverish as of today,3/1
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| 73 | 2021-02-28 | limb discomfort | Mental state delayed, arm felt heavy, dry mouth, odd sensation in head-transfer to ER |
| 73 | 2021-02-28 | muscle pain, musculoskeletal chest pain |
Nausea, diarrhea, rib cage pain so bad I couldn't lie down/sleep, exhaustion, Muscle aches and pain,...
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Nausea, diarrhea, rib cage pain so bad I couldn't lie down/sleep, exhaustion, Muscle aches and pain, loss of appetite, cough,
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| 73 | 2021-03-01 | back pain |
I started having lower back pain within hours of the 2nd shot, along with major headache, exhaustion...
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I started having lower back pain within hours of the 2nd shot, along with major headache, exhaustion By that night I had chills, exhaustion, back pain Since then, my back has been in spasm. Extremely, extremely painful spasm The pain is not movement related. I am fine while sleeping and generally while walking. Sitting or standing still brings on the pain
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| 73 | 2021-03-01 | musculoskeletal stiffness, muscle pain |
Arm is slightly stiff; Muscle is slightly sore; Sore arms; just little tender; This is a spontaneous...
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Arm is slightly stiff; Muscle is slightly sore; Sore arms; just little tender; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 01Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included medroxyprogesterone and estradiol. The patient previously took the first dose of BNT162B2 in Jan2021 for COVID-19 immunization (got the first shot exactly 3 weeks before for which the patient was not sure of the date). On 01Feb2021, just shortly after the patient and his husband both got the shot, the patient had sore arms by the time they drove home yesterday afternoon. The patient's sore arm was much better today but it was still just little tender - that is the only thing she had. Currently (02Feb2021), the patient's arm was slightly stiff still, just the muscle is slightly sore. No treatment was taken for the adverse events. The patient was recovering from "Sore arms; just little tender". The outcome of the other events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
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| 73 | 2021-03-01 | musculoskeletal stiffness | Chills, nausea, fatigue soreness and stiff at shot site. |
| 73 | 2021-03-01 | muscle pain | Strong headache fever jaw pain as if broken shortness of breath strong muscle soreness fatigue |
| 73 | 2021-03-03 | armpit pain |
Day of shot my left arm felt sore and also my left arm pit. By evening it was so sore it hurt to m...
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Day of shot my left arm felt sore and also my left arm pit. By evening it was so sore it hurt to move arm or touch arm pit. Morning after 1 PM second shot, my left eye was almost completely covered in blood. My arm pit also very sore and found a bruise on the side of my left breast and also on my left hip. I slept a lot and by the next day everything eased up. After another day my eye was clear and bruises fading. The last thing to go away was the soreness in my left arm pit.
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| 73 | 2021-03-03 | bone pain |
Heart skipping and racing for apx. 2 hours after vaccination. Headache Low grade fever Body ac...
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Heart skipping and racing for apx. 2 hours after vaccination. Headache Low grade fever Body aches. Pain in all bone including ankles, fingers, and toes and arches
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| 73 | 2021-03-03 | muscular weakness |
She was in her usual state of health until January 26 when she received her first dose of the Pfizer...
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She was in her usual state of health until January 26 when she received her first dose of the Pfizer COVID-19 vaccine and the second dose on February 18, 2021. Within 4 days of receiving this vaccine she noticed she fell on Monday, February 22 she was able to raise herself up she fell again on Tuesday, February 23 and on Thursday, February 24. By Friday she could not get up and she presented to hospital where she was noted to have lower extremity weakness. An MRI has revealed extensive edema of the whole of the spinal cord extending from the cervical region to the sacral area. She has lost motor function and sensation to the lower extremities as well. She has not had a bowel movement since Thursday, February 24 and she has had to have a Foley catheter placed because of difficulties passing urine.
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| 73 | 2021-03-03 | spinal pain |
She has immune issues and stress/ methylprednisolone for immune issues; She has immune issues and st...
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She has immune issues and stress/ methylprednisolone for immune issues; She has immune issues and stress/ methylprednisolone for immune issues; severe headache/ pain in the base of her skull; nausea; vomiting; had pain at the top of her spine where the spine meets the skull; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (BNT162B2, lot number: EL9264) via an unspecified route of administration, on 01Feb2021 12:45PM at a single dose on top of left arm for COVID-19 immunization. The vaccine was given at a Clinic which is an off shoot of the hospital. The patient did not receive any vaccinations within 4 weeks prior to receiving BNT162B2. Medical history included Wegner's disease, immune issues and stress. She stated that there would be one doctor providing medication for stress and other doctor providing other medications. She has immune issues and stress. Concomitant medications included buspirone from an unspecified date and ongoing (been on it for quite a few years), clonazepam from an unspecified date and ongoing (been on it for quite a few years), fluticasone propionate (FLOVENT) from an unspecified date and ongoing (been on it a little over a year or two and it was prescribed by her pulmonologist), hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) from an unspecified date and ongoing (has been on it for more than 5 years and was prescribed by her primary care), methylprednisolone for immune issues, bupropion hydrochloride (WELLBUTRIN), and nebulizer for saline for Wegner's disease (It is prescribed by her ear, nose, and throat doctor). The patient previously received a flu shot in 2020 and experienced sore arm and achy feeling. On 01Feb2021 18:45, the patient experienced severe headache, nausea, vomiting, and pain in the base of her skull. A lot of people thought it was throwing her into a migraine. She has never had a migraine in her life. It was awful and pretty extreme. Severe headache, nausea, vomiting, and pain in the base of her skull started about six hours after the shot (at 18:45) and proceed a good 24 hours later. She also had pain at the top of her spine where the spine meets the skull. She would say that the symptoms stopped on 02Feb2021. She has recovered almost completely. She is still not quite completely 100 percent. The reported adverse events did not require a visit to emergency room or physician office. Some relatives said she should have gone in, but she did not. Outcome of the events was recovered on 02Feb2021.
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| 73 | 2021-03-04 | joint pain, muscle pain, neck pain |
Severe case of shingles in left arm. Electrical shock type pain from left mastoid thru neck, shoulde...
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Severe case of shingles in left arm. Electrical shock type pain from left mastoid thru neck, shoulder, arm to palm, thumb and finger tips. Muscular pain from neck (felt like pinched nerve) thru shoulder to wrist (felt like carpel tunnel). Blooming painful pustule rash from shoulder to wrist on inner arm for one week. Post-herpetic and muscular pain continues through rash scabbing and drying, to date March 6, 2021. This is my second event in 37 years.
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| 73 | 2021-03-04 | muscular weakness, muscle pain |
March 1st--bedtime meds did not work causing me to have muscle pain and spasms. Next day all MS symp...
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March 1st--bedtime meds did not work causing me to have muscle pain and spasms. Next day all MS symptoms that had been in remission were now present. no strength in left injection arm, all muscles weakened. slight headache. All subsided about ten pm.
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| 73 | 2021-03-06 | muscular weakness |
2 am,,went to get out of bed, collapsed because legs wouldnt hold her up. Headache, 2 poilt fever, a...
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2 am,,went to get out of bed, collapsed because legs wouldnt hold her up. Headache, 2 poilt fever, arm rashes shoulder to wrist. Body aches and bad weakness for about a week. Rashes on arm and swollen arm lasted 9 days.
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| 73 | 2021-03-06 | muscle pain |
Extreme muscle pain, followed by severe headache, exhaustion, chills ,nausea 4 days after first covi...
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Extreme muscle pain, followed by severe headache, exhaustion, chills ,nausea 4 days after first covid shot
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| 73 | 2021-03-07 | joint pain |
Severe breathing distress lasting 3 days Diarrhea 2 days. Injection site pain. Headache joint pAin...
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Severe breathing distress lasting 3 days Diarrhea 2 days. Injection site pain. Headache joint pAin Fatigue
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| 73 | 2021-03-07 | joint pain |
3 days after second vaccination, had arthralgias feet, ankles, neck, shoulders and hands that has la...
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3 days after second vaccination, had arthralgias feet, ankles, neck, shoulders and hands that has lasted 10 days, No swelling. No rash
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| 73 | 2021-03-07 | joint pain |
48hours and still have fatigue and joint pain; 48hours and still have fatigue and joint pain; This i...
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48hours and still have fatigue and joint pain; 48hours and still have fatigue and joint pain; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration on the left arm on 28Jan2021 at 09:00 AM at a single dose for COVID-19 immunisation. The patient medical history was none. There were no allergies to medications, food, or other products. Concomitant medications included rosuvastatin calcium (CRESTOR) at 5mg, vitamin D and zinc. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced fatigue and joint pain on 28Jan2021 at 14:00 and after 48 hours also, was experiencing the events. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 73 | 2021-03-07 | joint pain |
Very next MORNING! My blood sugar readings every morning had been running @ 100 . HOWEVER, next m...
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Very next MORNING! My blood sugar readings every morning had been running @ 100 . HOWEVER, next morning after Covid shot, my blood sugar was 350. It continued that way for days. I started using more insulin the night before (when I usually take it). So I HAD been taking only 45 units at night. I was cautious and increased to 65 units on the 3rd night. That reduced my morning blood sugar readings to 220. Per my doctor's instructions, I have been taking that amount every night, but my blood sugar has only gone down to 175. This was my MAIN concern. But here are the other physical effects that have occurred since 2-25: great thirst, Joints hurt, teeth hurt, confusion, headache, fatigue, sleeping almost all day - all of these days since the shot. Something new started just last night (3-7-2021). Both of my legs hurt so much I could not fall asleep. They still hurt this morning. My joints ache in my hips, knees - Much worse than they normally do.
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| 73 | 2021-03-07 | limb discomfort |
3/4 Evening: injection site VERY sore. Too painful To sleep on. Disturbed sleep due to pain. 3/5:...
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3/4 Evening: injection site VERY sore. Too painful To sleep on. Disturbed sleep due to pain. 3/5: Morning; headache, fatigue Evening/overnight: arm still tender 3/6: Morning: fatigue, nausea, headache, lack of appetite, stomach upset. Hot flashes, no fever detected Afternoon: very nauseous, vomiting, headache Evening/overnight: not getting restful sleep 3/7: Morning: mild headache/lack of appetite Evening/overnight: woke in the middle of the night with severe stomach cramps, loose stool, nausea amd vomiting. No fever detected. 3/8 continues to be nauseous, lack of appetite and extreme fatigue.
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| 73 | 2021-03-08 | bone pain, muscle pain, joint pain, back pain |
Awakened at 2:00 am with low grade fever and muscle and bone aches. (ankle, knees, hip joints, back)...
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Awakened at 2:00 am with low grade fever and muscle and bone aches. (ankle, knees, hip joints, back) Experienced low grade fever and chills occasionally for3 days following injection. Today is day 4 and I have no side effects.
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| 73 | 2021-03-08 | musculoskeletal stiffness, muscular weakness |
73 yo F with renal mass was given her second Covid-19 vaccine IM in her right deltoid (lot# EN6206) ...
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73 yo F with renal mass was given her second Covid-19 vaccine IM in her right deltoid (lot# EN6206) on 3/4 at 1312. In the final minutes of this patient's 15 minute observation period, patient was noticed to have pulled her mask down and was looking at the observer as if she wanted to say something. Observer asked pt if she was ok. Patient nodded yes. A minute later, the patient dropped her purse and mumbled something. Patient's arm went up and patient became stiff and started seizing. Observer immediately called for help. Vitals, glucose and oxygen was placed on patient. EMS was called. Provider notified and went to patient who was sitting upright in chair actively having bilateral generalized
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| 73 | 2021-03-08 | muscle pain, joint pain |
Arm is very sore and it hurts in the muscle, this is very sore in the spot where they give me the in...
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Arm is very sore and it hurts in the muscle, this is very sore in the spot where they give me the injection; I have a slight fever of a 100; I feel I am cold, I have the chills; Headache; joint pain; muscle pain unbelievable; nauseous; I was sick all day; symptoms felt like when you are getting the flu and when you get the flu vaccine; tiredness; sweating; This is a spontaneous report from a contactable consumer, the patient. This 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 05Feb2021 (at the age of 73 years-old) for COVID-19 vaccination. Medical history included Parkinson's disease, bulging disc in the back and shoulder, anxiety, thyroid, had very bad case of, was in the hospital for 12 days and they were just supposed to put her on the ventilator, but then started to recover a little bit, was hesitating on taking the shot. But when she called the doctors they said no you can take it, even the neurologist said that you can take it because she had this disease and should be taking it. Historical vaccine included unspecified reaction from an unspecified flu vaccine on an unknown date. Concomitant medications included dexlansoprazole (DEXILANT), levothyroxine, paroxetine for anxiety, carbidopa, levodopa for Parkinson's disease, metoprolol succinate (METOPROLOL ER ACTAVIS) 25 mg, one a day and vitamin D NOS. On 05Feb2021, the patient experienced slight fever of a 100, felt cold, chills, headache, joint pain, muscle pain unbelievable, nauseous and was sick all day. On 06Feb2021, the patient's arm was very sore in the spot where they gave the injection and has no rash, it's not red in that area or any place else, It's just very sore and it hurts in the muscle, this is very sore in the spot where they gave the injection. On an unknown date in 2021, symptoms felt like when you are getting the flu and when you get the flu vaccine just a little more tiredness. Treatment to reduce the fever included acetaminophen (TYLENOL) and is sweating. Treatment was received for chills. The clinical outcome of slight fever of a 100, felt cold, chills was recovered on an unknown date. The clinical outcome of arm very sore in the spot where they gave the injection, headache, joint pain, muscle pain unbelievable, nauseous, sick all day, symptoms felt like when you are getting the flu and flu vaccine, tiredness and sweating was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 73 | 2021-03-09 | muscle pain | Headache, chills, indigestion; muscle aches; fatigue |
| 73 | 2021-03-11 | joint pain, muscle pain |
numbness to right arm following injection that has subsided but has left pain in the deltoid and rig...
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numbness to right arm following injection that has subsided but has left pain in the deltoid and right wrist. also noted elevated heart rate after leaving the clinic. refuses to go to pcp due to risk of COVID
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| 73 | 2021-03-11 | joint pain |
The next day after the injection, my knees were so sore that I could not walk and I was not sure the...
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The next day after the injection, my knees were so sore that I could not walk and I was not sure they would hold me up. It felt like the bones were rubbing against each other. (I have strong knees, and have never had any problem with them. ) Advil relieved the pain immediately. I slept at night with a heating pad on them, which helped. This week, March 12, I am finally able to walk without pain or wrapping my knees with ace bandages. They are still not ?normal?. I may have strained them in a 3-ft snow drift on Feb. 4, but I had no indication they were hurt at the time. I have had sprained ankles and recently broke my leg. The pain in my knees was like nothing I have endured so far...it?s onset was immediate.
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| 73 | 2021-03-11 | arthritis | Temperature of 100.8, finally broke after taking Ibuprofen and Tylenol Arthritis |
| 73 | 2021-03-11 | muscle fatigue, limb discomfort |
The day after receiving the vaccine, in the evening, the patient noticed her blood pressure was elev...
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The day after receiving the vaccine, in the evening, the patient noticed her blood pressure was elevated, she had muscle fatigue (both arms and both legs felt very "heavy"), and she felt as though she might faint but has yet to have a syncopal episode.
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| 73 | 2021-03-12 | muscle pain |
muscle ache, especially neck and hips and fever of 99.8 F. the evening of day after injection . Fee...
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muscle ache, especially neck and hips and fever of 99.8 F. the evening of day after injection . Feeling normal by second day.
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| 73 | 2021-03-14 | muscle pain |
Developed COVID. Detected by PCR. Had fever, chills, muscle aches, runny nose, nausea, headaches, f...
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Developed COVID. Detected by PCR. Had fever, chills, muscle aches, runny nose, nausea, headaches, fatigue, loss of taste and smell.
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| 73 | 2021-03-14 | muscle pain |
Slight muscle ache in arm; Other vaccine same date vaccine; Other vaccine same date vaccine; This is...
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Slight muscle ache in arm; Other vaccine same date vaccine; Other vaccine same date vaccine; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN9581) via unspecified route of administration in the left arm on 05Feb2021 at 15:45 (at the age of 73-years-old) as a single dose for COVID-19 immunization. Medical history included sulfa allergy from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. Concomitant medications included ascorbic acid (VITA C), ergocalciferol (VITA D), biotin, fexofenadine hydrochloride (ALLERFEX), magnesium, and glucosamine hydrochloride (GLOCOSAMIN), all from unknown dates for unknown indications. The patient did not receive any other vaccines in the four weeks prior to the COVID vaccine. On 05Feb2021 at 22:00 the patient experienced slight muscle ache in arm during the first night; and on 05Feb2021 the patient experienced other vaccine same date vaccine. No treatment was provided for the events. The clinical outcome of slight muscle ache in arm was recovered in Feb2021; the clinical outcomes of other vaccine same date vaccine were recovered on 05Feb2021. It was also reported the patient was not COVID tested post vaccination.
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| 73 | 2021-03-14 | muscle pain |
Developed COVID. Fever, chills, muscle aches, runny nose, cough, nausea, headaches, fatigue, loss ...
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Developed COVID. Fever, chills, muscle aches, runny nose, cough, nausea, headaches, fatigue, loss of taste and smell
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| 73 | 2021-03-16 | muscular weakness |
11PM - 6AM awoke shivvering from head to toe..woozy, head buzzing, couldn't see much except lavende...
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11PM - 6AM awoke shivvering from head to toe..woozy, head buzzing, couldn't see much except lavender splotches when eyes open; no strength in arms or legs: collapsed trying to get out of bedroom to bathroom & couldn't get up unassisted; collapsed again trying to get from bathroom back to bed - couldn't scoot or pull/raise myself up with my arms; needed help to sit & rest& collect myself; arms/legs had no strength at all.... couldn't move unassisted; took unknown amount of time for husband to help me back to bed....once in bed slept until 6AM.. still weak the following day but vision back to normal - used walker to get around..head still buzzing
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| 73 | 2021-03-16 | musculoskeletal stiffness, neck pain |
32 hours post vacc. injection, administered at a medical center (a community site-not my primary pro...
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32 hours post vacc. injection, administered at a medical center (a community site-not my primary provider), Sx began w/ nausea, low abdominal pain, stiff neck and achy pain at base of skull. W/in 20 minutes nausea became vomiting x5 events which stopped when Ondansetronws taken, authorized by an on-call physician at the clinic (my primary care provider). Chills w/out fever begun about 30 minutes post first episode of vomiting and continued into the earliest hours of 2/28/21 (4:00am). I reviewed my Sx not only with the clinic staff, but also my primary care physician on 3/2/21. She has provided prn Rx for possible Sx as needed for dose 2, March 19th, 2021.
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| 73 | 2021-03-16 | muscle pain, neck pain, joint pain |
Slight fever (1 degree above normal), slight sore throat, very sore muscles (shoulders, upper arms, ...
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Slight fever (1 degree above normal), slight sore throat, very sore muscles (shoulders, upper arms, neck, back hips, upper legs), lethargic. Sore throat resolved within a 8 hours. Fever resolved within 24 hours. Muscle pain still in progress 33 hours later. Have not taken any OTC treatments because I do not want to impede the vaccine's work.
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| 73 | 2021-03-17 | joint pain |
Chills - fever of 100.8 - extreme headache - arm pain and rash by injection site - joint pain throu...
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Chills - fever of 100.8 - extreme headache - arm pain and rash by injection site - joint pain through the whole body - swollen lymph nodes on left side of neck - pain so bad couldn't roll over in bed - fatigue
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| 73 | 2021-03-18 | joint pain |
Swelling of right hand including sore joints in wrist and fingers. This resolved by 3/1/2021. Hot ...
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Swelling of right hand including sore joints in wrist and fingers. This resolved by 3/1/2021. Hot flashes including drenching sweat , red neck and face and raised blood pressure. This occurred randomly. It was an almost daily event until 3/5/2021. This then reduced to 1 event every 2-3 days until the present. Last occurred on 3/18/2021.
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| 73 | 2021-03-18 | muscle pain |
Injection 2: day one: slight fever, chills, extreme muscle pain in both arms, legs and feet, head...
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Injection 2: day one: slight fever, chills, extreme muscle pain in both arms, legs and feet, headache, chest pain. First day. Injection 1: day one thru day three. Same as injection one. Headache was severe all three days.
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| 73 | 2021-03-19 | joint pain | Vomiting,diarrhea, chills joint pain all joints, dizziness Exhausted, breathlessness |
| 73 | 2021-03-20 | limb discomfort | felt "funny" hard to think, heavy arms, EMS transported to ER |
| 73 | 2021-03-21 | joint pain | arm and shoulder pain f/u call made; caller reports decrease in intensity of arm and shoulder pain |
| 73 | 2021-03-21 | muscle pain, joint pain | Exhaustion, headache, fever, muscle aches, joint paint, chills, vomiting, diarrhea, dizziness |
| 73 | 2021-03-21 | muscle pain |
Symptoms of muscle ache, then fever, then chills.started late afternoon, Tue., March 16, at 4:15 pm....
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Symptoms of muscle ache, then fever, then chills.started late afternoon, Tue., March 16, at 4:15 pm. At 2:am next morning, March 17, sudden severe nausea and diarrhea, severe headache, hot flashes and sweats continued for 2 hours. Intermittent syncope twice.
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| 73 | 2021-03-22 | muscular weakness |
Hospital Discharge Summary Note: Patient is a 73-year-old female with a past medical history signifi...
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Hospital Discharge Summary Note: Patient is a 73-year-old female with a past medical history significant for hypertension, hyperlipidemia, hypothyroidism, and breast cancer. She presented to the emergency department with reports of possible allergic reaction to Pfizer vaccine. Patient received her first dose of: Vaccine earlier today and approximately 5 minutes later developed a cough, diaphoresis, and lightheadedness. She was given 50 mg oral Benadryl in the ED. Patient then complained of tingling sensation throughout her body and was continuously coughing. She was brought to the emergency department for evaluation. Patient noted she felt jittery and "disconnected". In the ED her cough and dizziness significantly improved. Upon examination, patient was noted to have right lower extremity weakness. She denied any weakness. CT of the head was performed to rule out stroke. Neurology was consulted. CT head brain was negative however patient was still having right-sided weakness. Emergency department physician confirmed the patient was able to get up without difficulty after receiving her vaccine at 1415 immediately following her vaccine. It was determined she was within the window for TPA. Patient was transferred to the ICU for further management.
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| 73 | 2021-03-22 | musculoskeletal stiffness | painful arm that received the vaccine, gas and cramping, headache, fatigue, stiffness |
| 73 | 2021-03-23 | back pain |
Sat. Mar. 20 at about 9:30 experienced back ache at center right . The back pain got worse overnigh...
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Sat. Mar. 20 at about 9:30 experienced back ache at center right . The back pain got worse overnight . On Sun. Mar 21 had headache in addition to back ache and very tired. Used BioFreeze on my back and took Tylenol throughout the night Sat. and all day Sun. All symptoms were gone by Mon. Mar 22.
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| 73 | 2021-03-23 | back pain |
started about 15 hours after dose # 2 on 18Feb2021.I had flu like symptoms.; achy legs; achy back; ...
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started about 15 hours after dose # 2 on 18Feb2021.I had flu like symptoms.; achy legs; achy back; chills; fatigue; Headache; runny nose; mild cough; This is a spontaneous report from a contactable consumer. This 73-year-old female consumer (patient) reported that she received the second dose of BNT162B2 (Lot number: EN6200) at single dose for covid-19 immunization on 18Feb2021 (08:15 AM, at left arm). Relevant history included allergies with Sulfa drugs. Relevant concomitant drug was unknown. The patient received the first dose of BNT162B2 (Lot number: EN9625) for covid-19 immunization on 28Jan2021 (08:15 AM, at left arm). The patient did not receive other vaccine in four weeks. No other medications received in two weeks. The patient stated about 15 hours after dose # 2 on 18Feb2021, at 11:30 PM, she started to have flu like symptoms (achy legs and back, chills, and headache which recovered by 7:00 am the following day. Started about 7 am the day following, very runny nose(used 2 boxes of tissue in 24 hours) and had intermittent headache and fatigue. At the reporting time (day 3) and she was still having very runny nose and mild cough. No treatment was received. Outcome of event was resolving. The patient was not infected COVID prior vaccination. The patient did not have COVID test post vaccination.
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| 73 | 2021-03-24 | musculoskeletal stiffness |
Stiff neck started after arriving home at 11:30 am Slept for four hrs due to not sleeping much the e...
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Stiff neck started after arriving home at 11:30 am Slept for four hrs due to not sleeping much the evening before 5:30 pm I noticed lymph swelling left side of my neck where stiffness notes earlier I took Tylenol 500mg at 10:00 pm Because of NHL I thought I should advise you of this side effect
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| 73 | 2021-03-24 | muscle pain |
one day of fatigue, then 2 1/2 weeks later sore muscles, chills, headache, tight chest. Fever develo...
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one day of fatigue, then 2 1/2 weeks later sore muscles, chills, headache, tight chest. Fever developed. Subsiding now at 3 1/2 weeks.
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| 73 | 2021-03-24 | muscle pain |
Shortness of breath, severe muscle aches, eyesight impacted, impacted thought processes. This shot ...
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Shortness of breath, severe muscle aches, eyesight impacted, impacted thought processes. This shot is NOT SAFE!!!!
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| 73 | 2021-03-25 | arthritis | Severe arthritis flare that lasted 2 weeks, before subsiding. Resulted in difficulty walking. |
| 73 | 2021-03-25 | neck pain | chills, fatigue, swollen face, rt side of neck sore |
| 73 | 2021-03-27 | joint pain, neck pain |
That Thurs evening arm neck hurt...then killer headache. Went to bed fever, body aches joints burned...
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That Thurs evening arm neck hurt...then killer headache. Went to bed fever, body aches joints burned. Sat fever back to normal. Didn't eat just drank water. Sunday skin felt prickly...yep shingles. Took valcyclovor and applied Ravensara.
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| 73 | 2021-03-28 | muscle pain |
On 3/25/2021, I started having chills; since then I have been running a fever; temperature up to 101...
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On 3/25/2021, I started having chills; since then I have been running a fever; temperature up to 101. I predominately have the fever and muscle ache. No loss of taste or smell. Some diarrhea (2X).
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| 73 | 2021-03-28 | muscle pain |
Was awoken w bad headache/eye ache in middle of night follow vaccination (2nd Covid) previous mornin...
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Was awoken w bad headache/eye ache in middle of night follow vaccination (2nd Covid) previous morning. Over the next few hours, experienced bad muscle pains throughout body, cd barely move. Chills, cd not get warm, even wearing thermal underwear top & bottom, fleece jacket, in bed w flannel sheets, one quilt, one thick heavy woolen blanket & a woolen throw blanket. Cd not get out of bed for many hours. Eventually, Saturday 3/27 took temp--100.5, v high for me as normal morning temp is 96.7-97.1. Oxygen saturation 94% (normal for me--89-99%). Most scary, pulse rate of 92 (normal resting pulse for me--68-72) while I was inert, in bed.
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| 73 | 2021-03-29 | joint pain |
Joint pain everywhere weak fatigue flareup of lipus or myasthenia gravis mid morning after sweeping...
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Joint pain everywhere weak fatigue flareup of lipus or myasthenia gravis mid morning after sweeping garage and moving arm a lot after being in remission sunce 2009
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| 73 | 2021-03-29 | joint pain |
Oxygen level decreased; Heart rate increased; couldn't get out of bed; Tired; Dizziness; joints hurt...
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Oxygen level decreased; Heart rate increased; couldn't get out of bed; Tired; Dizziness; joints hurts; This is a spontaneous report from a contactable consumer via medical information team.A 73-years-old female patient received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number :unknown) via an unspecified route of in Arm Right on 04Feb2021 07.00 as single dose for covid-19 immunisation. Medical history included asthma from 1971 , oesophageal spasm from 1981, diverticulitis ,concussion syndrome, anaphylactic shock .She has had anaphylactic shocks 4 times in her life. Concomitant medication included fluticasone propionate/ salmeterol xinafoate (ADVAIR) taken for asthma, fluticasone propionate/salmeterol (WIXELA INHUB) taken for asthma. On 04Feb2021 the patient stated couldn't get out of bed. On 09Feb2021 the patient experienced oxygen level decreased, heart rate increased. In Feb2021 patient experienced tired , dizziness and joints hurts.It was reported that She didn't have any anaphylactic shock after the COVID-19 vaccine. She had no reaction. After receiving the vaccine, she sat there with her husband for half an hour. In fact, nothing was wrong with her for 2 hours after receiving the vaccine. Then all of a sudden later on that day, she couldn't get out of bed. It was like she was sleeping, but wasn't sleeping. This lasted from Thursday around 11 a.m. until Monday, that kind of thing. She went to the doctor that Tuesday because she had her physical already scheduled .When she went to the doctor, it was determined her heartrate was 120. Her heartrate sitting or resting is usually in the 80's. Then, her heartrate was 120's four days after the vaccine. She didn't realize a racing heartrate was one of the severe effects of the vaccine. She didn't feel her heart was racing. Her doctor instructed her to drink Gatorade and Pedialyte and she is still tired after doing all of that. Her doctor said she should have the shot, even though her blood heartrate went up 40. Her oxygen level is usually at 98 although she does have asthma, and her level was at 90. It was lower, under 98. She explains she had an EKG done at the doctors.She stated she was extremely dizzy in the beginning when she did get up and take a shower. Every day, her husband helped her get in the shower and take a shower. She received her first EKG when she went to the doctor on Tuesday 09Feb2021. The only thing wrong was her heart rate was 120. Her heart rate is usually high anyway usually 80 and sometimes 90. Thee has only been one time in the last 25 years, her heart rate went to 126. On 15Feb2021 EKG which showed HR as 106, oxygen was 96. The patient did not received prior vaccinations within 4 weeks. The outcome of the events dizziness was recovering, outcome of the event joints hurts was not recovered and outcome of the events were unknown
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| 73 | 2021-03-30 | joint pain |
shooting joint pain in both hands both wrists when moving, lifting small items, finger and wrist joi...
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shooting joint pain in both hands both wrists when moving, lifting small items, finger and wrist joints "lock"; finger and wrist joints "lock" during routine tasks; during routine tasks followed by radiating pain; This is a spontaneous report from a contactable consumer reported for himself. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, lot number: en6198), dose 2 via an unspecified route of administration, administered in arm left on 26Feb2021 as a single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 via an unspecified route of administration, administered in arm right on 05Feb2021 12:15 (lot number: el3246) as a single dose for COVID-19 immunisation. Medical history included known allergy to lithium, meloxicam, nightshade vegetables. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications in two weeks included losartan 100, spironolactone 50, loratadine 5, all taken for an unspecified indication, start and stop date were not reported. On 27Feb2021 08:00, the patient experienced shooting joint pain in both hands both wrists when moving, lifting small items, finger and wrist joints "lock" during routine tasks followed by radiating pain. No treatment received for the adverse event. This is a non-serious report. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was unknown.
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| 73 | 2021-03-30 | joint pain |
Sore shoulder; This is a spontaneous report from a contactable consumer (patient) received via medic...
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Sore shoulder; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL1283), via an unspecified route of administration on 12Jan2021 (at an age of 73-years-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She got her first dose on 12Jan2021 at the center (City name withheld) and scheduled to come back for her second dose 4 weeks after receiving her first dose. The appointment for 4 weeks out was already made for 09Feb2021, states she did not know who to call to change it. Upon follow up on 08Feb2021, patient reported that when she originally scheduled her appt. online, she was told that she would get moderna and follow up appt. in 4 weeks. When she ended up getting Pfizer, she tried to change her appt. to 3 weeks, but she was not able to. She called the county and was told it would be ok to have it at 4 weeks per their epidemiologist. She had no side effects other than a sore shoulder that night. Patient was not admitted to the hospital due to the event. No treatment was received for the event. The outcome of the event sore shoulder was unknown. Upon Follow-up (08Feb2021): New information received from a contactable consumer. This consumer reported in response to Non-HCP letter sent which included: patient details (age group: adult, weight: 123 lb, height: 5 feet, 2 inches), new event (sore shoulder), treatment and clinical information. No follow-up attempts are possible. No further information is expected.
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| 73 | 2021-03-31 | back pain, muscle pain |
Severe heartburn started 3/31 at 6pm. It has persisted off and on with some relief with Tums. Sever...
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Severe heartburn started 3/31 at 6pm. It has persisted off and on with some relief with Tums. Severe diarrhea started 4/1 12:30am, with multiple bouts through 4:30am. Headache onset 4/1. Muscle aches- primarily back pain started 3/31.
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| 73 | 2021-03-31 | muscle pain, joint pain |
100.4 Fever, Injection site pain, tiredness, headache, muscle pain, chills, joint pain, feeling unwe...
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100.4 Fever, Injection site pain, tiredness, headache, muscle pain, chills, joint pain, feeling unwell and weakness. Started this morning around 9am. Got worse over the day. She did her dialysis cause she needed it. That makes her weak sometimes but she doesn't get any of the other symptoms from dialysis. Her vaccination shot was yesterday.
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| 73 | 2021-04-03 | joint pain |
Woke up with soreness in my hips. Later in the day became slightly nauseous. Both resolved by the...
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Woke up with soreness in my hips. Later in the day became slightly nauseous. Both resolved by the next day.
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| 73 | 2021-04-03 | muscle tightness |
This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient rec...
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This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9ZUZ, Expiration date: UNKNOWN), an unspecified route of administration in arm left on 05Feb2021 at 20:30 as a single dose for COVID-19 immunization. Medical history included chronic kidney disease, borderline high cholesterol, osteoporosis from an unknown date and unknown if ongoing. The patient had no allergies. The patient's concomitant medications were not reported. The patient did not received any other vaccine within 4 weeks and not received any other medication within 2 weeks. The patient was not tested prior to COVID-19 vaccination and not tested for COVID-19 after vaccination. The patient experienced neck started to feel tight on 05Feb2021 at 20:30. The patient has said that that about 25 minutes after shot left side of my neck started to feel tight. I could talk and swallow and after about 10-15 minutes feeling went away. The patient did not receive treatment for the event. The outcome of the event was recovered on an unspecified date 2021. No follow-up attempts are possible. No further information is expected.
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| 73 | 2021-04-03 | muscle pain |
Injection site swelling; puffy/there is not a big lump there; Injection site redness; Injection site...
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Injection site swelling; puffy/there is not a big lump there; Injection site redness; Injection site itching; Some muscle pain/muscle ache; This is a spontaneous report from a contactable consumer (patient, self-reported). A 73-year-old female patient received a second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration dates were not reported), via intramuscular route of administration in left arm on 28Jan2021 10:45, as single dose for prevent covid/COVID-19 immunisation. The patient's medical history was not reported. Patient took unspecified concomitant medications (She was taking a lot of mediations, it is too long of a list to go into). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was unknown), via an intramuscular route of administration in left arm, on 07Jan2021 around 11:30-11:45 am, for COVID-19 immunisation and on an unknown date, the patient received tetanus shot and experienced ache. It was reported that, she got the second dose of the COVID vaccine last Thursday (28Jan2021). On 28Jan2021, patient had muscle pain/muscle ache. Patient had injection site swelling, injection site redness and injection site itching on 29Jan2021. Reported it kind of looks like a circle and it seems like according to paperwork that it was not an usual reaction or side effect. She wanted to make sure that these are reported reactions to the vaccine. Clarified swelling as it was puffy and there was not a big lump there. Stated that the muscle ache was like an ache when you get a tetanus shot and It was a little worse. She did not think about it till today. She has an aide that comes once a week and was advised to bring it to the attention of the doctor. She still had some muscle pain as of 02Feb2021. Seriousness of the events was reported as non serious. The outcome of the all the events was reported as worsened/not recovered (at the time of the report). Information on the lot/batch number has been requested.
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| 73 | 2021-04-03 | muscle pain |
Fever; Chills; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 73...
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Fever; Chills; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Mar2021 at the age of 73-year-old at SINGLE DOSE for COVID-19 immunization. Medical history included COVID-19 from Dec2020. Concomitant medications were reported as none. Patient mentioned she had COVID-19 last Dec2020, received the Pfizer-BioNTech COVID-19 Vaccine first dose this Mar2021. Patient reported to have the "normal reaction" of the vaccine (fever, chills, muscle ache). Patient mentioned that she saw doctors on TV that said it would be okay to not get the second dose if had COVID-19 before and experienced the "normal reaction" to the vaccine. Patient was seeking information on this. Treatment was received for fever, chills, muscle ache. Outcome of events was unknown. Information on Batch/Lot number has been requested.
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| 73 | 2021-04-04 | joint pain |
1. Diarrhea beginning 3-24-2021 and symptoms decreasing 4-4-2021. 2. 4-5-2021 Awoke feeling very ach...
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1. Diarrhea beginning 3-24-2021 and symptoms decreasing 4-4-2021. 2. 4-5-2021 Awoke feeling very achy in all joints, left arm at injection site hot, sore, swollen, itchy, and raised red rash. No fever.
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| 73 | 2021-04-09 | joint pain |
pain over her heart area; pain in the right shoulder where she got the shot; Pain in the right shoul...
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pain over her heart area; pain in the right shoulder where she got the shot; Pain in the right shoulder; pain in the right shoulder travels down the right arm. It goes down the shoulder and down the arm; tooth ache; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN6198, via an unspecified route of administration administered in right arm (shoulder) on 03Mar2021 10:00 at single dose for COVID-19 immunisation. Medical history included diabetes, blood pressure abnormal, thyroid problems, fall (fell a couple of years ago), and trouble with her shoulder (prior to getting the vaccine). She reported that she did have some trouble with her shoulder prior to getting the vaccine. She fell a couple of years ago and the doctor's x-rayed it and thought it was pulling away from the bone. They didn't have to do surgery. She was completely over that and it had resolved before getting the vaccine. Patient has no additional vaccines administered on same date of the Pfizer suspect. Patient has no prior vaccinations within 4 weeks. Concomitant medications included metformin hydrochloride, sitagliptin (JANUMET) taken for diabetes from an unspecified start date and ongoing (been taking it a long time over 20 years); glipizide taken for diabetes, start and stop date were not reported (been taking it a long time over 20 years); losartan taken for blood pressure from an unspecified start date and ongoing (been on it about 10 years, her blood pressure is in between and it doesn't bother her a lot, it is not really high or low); and thiamazole (METHIMAZOLE) taken for thyroid problem from an unspecified start date and ongoing (been on it about ten years). Patient was calling because she had her first Pfizer shot about three weeks ago. About three days after on 06Mar2021, she developed pain in the right shoulder where she got the shot. It has been bothering her up until this time. She also had a pain over her heart area. The pain over her heart area occurred when she was breathing it. That has gone away. She had her second shot today and she was trying to explain to the doctor what happen to the right shoulder. He said the shot had to be in the other shoulder and he put it in the left shoulder in the bone. It hit the bone. She hollered because it hurt so bad. He said no one ever jumped like that before. She jumped because it hurt. She still has the pain in the right shoulder, but she doesn't feel anything in the left where she got it today. She clarified Pfizer shot as COVID19 vaccine. The pain in the right shoulder travels down the right arm. It goes down the shoulder and down the arm in Mar2021. She got first and second dose. She got the first dose of COVID19 vaccine on 03Mar2021. Pain in the right shoulder: it felt like her toothache has something to do with the pain in the shoulder. The toothache came on a little later (Mar2021) than the pain in the shoulder. The tooth ache is still ongoing, but it has improved. Pain over heart area: It started at the same time as with the pain in the right shoulder. The pain over the heart stopped about a week ago. She thinks she has recovered completely. She didn't have anything done for the heart pain. She got the second dose today, 25Mar2021, lot number: ER8733, Expiry date: unknown. The outcome of the events 'pain over her heart area and pain in the right shoulder travels down the right arm/it goes down the shoulder and down the arm' was recovered, event tooth ache was recovering, and events 'pain in the right shoulder where she got the shot (vaccination site pain) and pain in the right shoulder' was not recovered.
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| 73 | 2021-04-23 | joint pain |
sharp pain in right shoulder; Headache; Chills; Fever; This is a spontaneous report from a contactab...
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sharp pain in right shoulder; Headache; Chills; Fever; This is a spontaneous report from a contactable consumer (reported for herself). A 73-years-old female patient received BNT162B2 (BNT162B2, Solution for injection, Lot Number: ES9261), via intramuscular route of administration in left arm on 02Feb2021 at 08:45 am as single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient had pain in her right shoulder hit her, then it went up into her head and it was horrible. The pain in her right shoulder in her joint went away when the pain moved to her head. Between 430-5pm the pain started in her head. It was the worst headache she ever experienced. She could not even clear her throat since it felt like the top of her head was going to come off. By 9pm her headache was subsiding, and she had a good night's sleep and had fever and chills. The patient received Tylenol. The outcome of the events sharp pain in right shoulder and Chills was recovered on 05Feb2021.The outcome of the other events was unknown.
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| 73 | 2021-04-24 | musculoskeletal stiffness |
Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mou...
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Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mouth, first vaccine.; Blood and clots came out of nose and mouth, first vaccine.; Face felt tight, first vaccine.; Mouth and nose dry, first vaccine.; Mouth and nose dry, first vaccine.; Sore arm, first vaccine.; This is a spontaneous report received from a contactable consumer(patient). A 73-year-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 73-years-old, via an unspecified route of administration, administered in Arm Left (in the back of the arm) on 20Jan2021 (maybe at 11:10 am) (Lot Number: EL3246; Expiration Date: Apr2021) as single dose for covid-19 immunisation. Medical history included ongoing Postural vertigo maybe 10 years ago for a day. No family medical history relevant to AE. The patient's concomitant medications were not reported. Patient got the Shingles vaccine years ago and the next day, she had a sore arm and tingles, up and down her arm. She didn't feel food for 7 days and felt achy. It was the first Shingles shot. No prior Vaccinations (within 4 weeks). The patient experienced blood and clots came out of nose and mouth on 21Jan2021 (the same time that she woke up) with outcome of recovered on 21Jan2021. She blew her nose and leaned over and noticed a drop of blood on the rug and grabbed a Kleenex. She blew her nose, easy, and all of a sudden blood and clots came out of her nose and mouth. It lasted for about 8 minutes. Sore arm on 20Jan2021 (started in the evening) with outcome of recovered on 21Jan2021. Face felt tight on 21Jan2021 (around 8:30 or 9:00 am) with outcome of recovered on 21Jan2021. Mouth and nose dry on 21Jan2021 (in the morning) with outcome of recovered on 21Jan2021.
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| 73 | 2021-04-28 | back pain | Chest and back pain. eR visit. CT scan. Pulmonary Emboli in right lung. 24 hrs |
| 73 | 2021-05-03 | joint swelling |
chronic lyme disease; could not breath/shortness of breath; knees swelled up; eyes burned; significa...
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chronic lyme disease; could not breath/shortness of breath; knees swelled up; eyes burned; significant fatigue; increase in body pain; my knees are still damaged, especially in the back; knees still damaged, especially in the back; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 73-year-old via an unspecified route of administration, administered in Arm Right on 28Mar2021 14:00 (Lot Number: ER8733) as single dose for covid-19 immunisation. Medical history included hepatitis c, persistent lyme disease (ongoing), Known allergies: some antibiotics and foods. There was no other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. There were no concomitant medications. The patient experienced could not breath, had to walk around for 20 minutes, she had chronic lyme disease. Her knees swelled up, her eyes burned, she had shortness of breath. Now three weeks later her knees were still damaged, especially in the back and she still had significant fatigue and increase in body pain, but the shortness of breath upon walking had improved. The back of her knees had never been this bad. She -would never have another shot-think it would kill her. The events start date was 28Mar2021. No treatment was received. The outcome of event Dyspnoea was recovering, of knees still damaged, especially in the back, fatigue and increase in body pain was not recovered, of other events was recovered with sequel.
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| 73 | 2021-05-03 | rheumatoid arthritis |
Flare/hands, wrists and elbows were painful; This is a solicited report from a non-Pfizer sponsored ...
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Flare/hands, wrists and elbows were painful; This is a solicited report from a non-Pfizer sponsored program from a contactable consumer, based on information received by Pfizer, license party for etanercept (ENBREL). This serious solicited report was reported to Amgen on 19Apr2021 by a consumer from a commercial program and involves a 73 year old female patient who had a flare/hands, wrists and elbows were painful [PT: rheumatoid arthritis] while receiving Enbrel, Single Dose Prefilled Syringe. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. The patient's concomitant medications included covid-19 vaccine. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Syringe on an unknown date (for over 10 years ago prior to this report). On 03Feb2021 and 24Feb2021, the patient stated that she received the Pfizer COVID vaccines and in both instances approximately 36 hours after the vaccine she experienced a flare. She stated that her hands, wrists and elbows were painful with a scale of five out of 10. The patient stated that the flares were resolved approximately six days later. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as recovered/resolved. The event rheumatoid arthritis was resolved on unknown date in Mar2021. Action taken with Enbrel and Single Dose Prefilled Syringe was reported as unknown for the event rheumatoid arthritis. The causal relationship between the event rheumatoid arthritis, Enbrel and Single Dose Prefilled Syringe was not provided by the consumer. The reporter declined to provide lot number. The reporter declined consent for follow up. Causality Assessment (etanercept): Rheumatoid arthritis flare up, Per Company (Amgen) = No. Amgen comment: This individual report does not change the safety profile of the product. No follow-up attempts are possible. No further information is expected. Follow-up (19Apr2021): This is a follow-up solicited report from a non-Pfizer sponsored program , based on information received by Pfizer from Amgen, license party for etanercept (ENBREL). Correction Dated 19Apr2021: Version created to update covid-19 vaccine from concomitant medication to co-suspect medication as it was more likely associated with reported event rheumatoid arthritis. The reporter's assessment of the causal relationship of the events with the suspect product etanercept was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Event a flare/She stated that her hands, wrists and elbows were painful with a scale of five out of 10 is likely due to underlying condition and unrelated to etanercept. Based on chronological connection to the vaccine the event rheumatoid arthritis flare was possibly related to BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 73 | 2021-05-06 | joint pain, arthritis, muscle pain, joint swelling |
All joints are inflamed, swollen and extremely painful.; All joints are inflamed, swollen and extrem...
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All joints are inflamed, swollen and extremely painful.; All joints are inflamed, swollen and extremely painful.; All joints are inflamed, swollen and extremely painful.; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; muscles, ligaments, tendons etc are also inflamed and painful; This is a spontaneous report from contactable consumer (patient). A non-pregnant 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 26Feb2021 at 18:30 (at the age of 73 years old) (Lot Number: EN6202, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included lupus and known allergies to penicillin and cephalosphorins. Concomitant medications included prednisone; and boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN). The patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, unknown expiration) on 03Feb2021 at 20:30 in right arm for COVID-19 immunisation at the age of 73 years old. The patient experienced all joints are inflamed, swollen and extremely painful; and muscles, ligaments, tendons etc are also inflamed and painful on 27Feb2021 at 05:00. The patient not been able to exit her house. The events resulted in physician office visit. The patient received treatment for the events. The patient did not receive other vaccines in four weeks. The patient had not yet recovered from the events. The events were assessed as serious (disability). No follow-up attempts are possible. No further information is expected.
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| 73 | 2021-05-11 | joint pain |
brain fog; couldn't keep eyes open; sore shoulder; This is a spontaneous report from a contactable c...
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brain fog; couldn't keep eyes open; sore shoulder; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: unknown) via an unspecified route of administration, administered in Arm Left on 24Jan2021 16:00 (at the age of 73-year-old) as SINGLE DOSE for covid-19 immunization. Patient not pregnant at the time of vaccination. Medical history included hypothyroid and allergies to latex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included vitamin d3; calcium; iron and thyroid meds. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 25Jan2021 at 14:00, 24 hours after shot, the patient experienced brain fog, couldn't keep eyes open, sore shoulder, the runs. The seriousness criteria reported was non-serious. The Patient did not received treatment for the adverse events. The outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested. Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
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| 73 | 2021-05-14 | muscle pain, joint pain |
terrible muscle/joint pain; terrible muscle/joint pain; This is a spontaneous report from a contacta...
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terrible muscle/joint pain; terrible muscle/joint pain; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: 9266), via an unspecified route of administration, administered in the left arm on 14Feb2021 at 10:00 as a single dose for COVID-19 immunization. Medical history included ongoing lung cancer and known allergy to lobster and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 25Jan2021 on the left arm for COVID-19 immunization. On 16Feb2021 at 03:00 the patient had terrible muscle/joint pain since the second dose of the vaccine. It gets worse everyday. The event caused a doctor or other healthcare professional office/clinic visit. The patient has not recovered from the events. The events were reported with a seriousness of disability.
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| 74 | 2021-01-12 | joint pain |
Received COVID vaccination on 01/06/2021 at 8:00 at the COVID vaccinations clinic. About 2:20pm emp...
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Received COVID vaccination on 01/06/2021 at 8:00 at the COVID vaccinations clinic. About 2:20pm employee states that Left arm started aching. Around midnight, employee states that right elbow began to ache as noticed redness and swelling approximately 2-3 inches below injection site. States swelling and redness increased over the course of two days. Friday, the swelling and redness began to improve.
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| 74 | 2021-01-12 | joint pain |
Got really sick overnight; Headache; Chills; Body aches; Nausea; Joints hurt; This is a spontaneous ...
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Got really sick overnight; Headache; Chills; Body aches; Nausea; Joints hurt; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899), via an unspecified route of administration on 04Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 vaccination. Medical history included thyroid disorder. Concomitant medications included levothyroxine from an unknown date at 100 (units not provided) for thyroid. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) on an unknown date (at the age of 74-years-old) as a single dose for COVID-19 vaccination. After the patient received the second BNT162B2 vaccine dose, overnight the patient got really sick, the patient experienced headache, chills, body aches, nausea, and joints hurt, all on unknown dates in Jan2021, per the patient it started during the night. The patient received ibuprofen (ADVIL) as treatment for the events. The clinical outcome of got really sick overnight and chills were unknown and the outcome of the events headache, body aches, nausea, and joints hurt was not recovered. It was also reported that the patient has been tested for COVID-19 with unknown results, the patient stated they get a COVID test every week at work.
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| 74 | 2021-01-14 | back pain |
Resident had severe confusion. She thought she was in another state and that we were all strangers. ...
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Resident had severe confusion. She thought she was in another state and that we were all strangers. She has a decrease in her appetite and an increase in thirst. She complained of low back pain with aches all over her body. She also stated that she had very vivid dreams. this is not at all the typical behavior that we have seen in her. Previous labs were checked and all were within normal range.
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| 74 | 2021-01-19 | neck pain | Unable to move head and neck due to soreness |
| 74 | 2021-01-21 | joint pain |
As I was getting ready for bed my joints felt achy. Around 11:00 p.m. it felt like every joint in my...
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As I was getting ready for bed my joints felt achy. Around 11:00 p.m. it felt like every joint in my body was on fire. Also add headache could not hardly stand to lay my head on the pillow. About 4 AM I could not tolerate the situation any longer and took 600 mg of Tylenol. After that was able to rest some. The next day after the vaccination my joints were achy moderately and I have a headache. The injection site was tender to the touch and arm range of motion decreased and arm sore. Took 400 ibuprofen about 4 PM day after injection to ease Reactions
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| 74 | 2021-01-21 | muscle pain | Chills, muscle ache, headache. |
| 74 | 2021-01-23 | joint pain, muscle pain |
Approx 7:00pm on the 22nd of January had a dull headache. The next day had muscle pain, joint pain...
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Approx 7:00pm on the 22nd of January had a dull headache. The next day had muscle pain, joint pain, and chills. Also injection site was sore. Took Advil for pain and aches.
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| 74 | 2021-01-23 | joint pain |
On 1/20/21 I had the 1st Covid 19 vaccine in my left arm at 1:10pm and at exactly 9:00pm that evenin...
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On 1/20/21 I had the 1st Covid 19 vaccine in my left arm at 1:10pm and at exactly 9:00pm that evening I experienced a pain on my right side that went along the outside starting at the base of my little toe and continuing to the heel of my foot and from there going right on up the outside of my right leg to the base of my hip. At this point I laid down which made the pain a little better. I tried rubbing the area but that didn"t help much. I did take one advil an hour before bedtime but the moderate pain stayed the same. At midnight I went to bed and was able to sleep. By morning I was fine.
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| 74 | 2021-01-23 | neck pain, joint pain |
Starting about 11PM, left arm from fingers up my arm to below my ear, across to my right shoulder ac...
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Starting about 11PM, left arm from fingers up my arm to below my ear, across to my right shoulder ached, had chills, and could not get comfortable in bed. Once up at 7 AM took two Advil 200mg with relief
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| 74 | 2021-01-24 | musculoskeletal stiffness, neck pain |
Developed hives on my face, on my head, on top of my back and they also itch in addition to the all ...
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Developed hives on my face, on my head, on top of my back and they also itch in addition to the all over itching; headaches; Pain around my face, my left arm; Developed severe itching from head to toe; I was running a temperature of 102; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; I could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move; Appetite lost; Chills; soreness more than usual from the shot; Soreness in my arm, my neck; Soreness in my arm, my neck/ pain around her face, her left arm; I got stiff neck, my back, my lower back; Massive weakness; Confusion; terrible sleepiness; Diarrhea; I still don't feel good; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received her second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot EL3248, expiration Apr2021) at 6:00AM on 07Jan2021 for Covid-19 immunization. The patient had her first dose on 19Dec2020 and had side effects from it but very few. The patient was worked at COVID rooms to clean rooms in hospital as a housekeeper and so her exposer to the hospital made her in first group to get the vaccine. Medical history included allergies (had anaphylactic shock from Amoxicillin and from Tylenol, she cannot take Tylenol), anxiety, and high blood pressure. Concomitant medications included acetylsalicylic acid (ASPIRIN) on regular basis, bisoprolol fumarate, loratadine (CLARITIN) for allergies, escitalopram for anxiety, mometasone furoate (FLONASE) for allergies, losartan, magnesium, omeprazole, and triamterene. On the first day (07Jan2021) she had soreness more than usual from the shot, soreness in her arm, her neck. She got stiff neck, back, lower back. She had gotten the shot at 6 am, then worked at that time and by the time she got home at noon, she had massive weakness, some confusion, terrible sleepiness and by evening, she developed diarrhea. On the second day (08Jan2021) the pain increased the weakness increased, and she was running a temperature of 102. She could not even sit on the side of bed without falling to one side or the other or falling backwards so very weak and unable to move pretty much. She could not eat and lost appetite, and she developed the chills on that evening. On the third day (09Jan2021) she was running a temperature of 101 so it had gone down. She still had headaches, and pain around her face, her left arm and developed severe itching from head to toe, and on the next day (10Jan2021) she developed hives on her face, on her head, on top of her back and they also itch in addition to the all over itching. The temperature was gone, she had no temperature when she developed the hives. At the report day, she stated that she had not gone back to work as she broke out in the horrible hives and she still did not feel good. Only cold ice packs on the hives/ itching and no more treatment received for the events. The fever and itching resolved on 10Jan2021, and outcome of all other events was unknown.
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| 74 | 2021-01-24 | muscle pain, joint pain | injection site pain, fatigue, headache periodically, muscle and joint pain |
| 74 | 2021-01-26 | joint pain, muscle pain |
Severe headache; tiredness; muscle pain; chills; fever 99.7; joint pain; feeling unwell; cough; no a...
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Severe headache; tiredness; muscle pain; chills; fever 99.7; joint pain; feeling unwell; cough; no appetite; This is a spontaneous report from a contactable consumer reported for self. This 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246) via unspecified route of administration at 08Jan2021 10:30 AM at single dose in right arm for COVID-19 immunization. The patient is not pregnant. The age at vaccination is reported as 74 years old. The patient medical history and concomitant medications were not reported. The patient previously received benzoin and experienced allergy. The patient experienced severe headache, tiredness, muscle pain, chills, fever 99.7, joint pain, feeling unwell, cough, no appetite at 15Jan2021 18:00 PM. The events are reported as non-serious by reporter. The patient received no treatment. The patient was not diagnosed with COVID-19 prior to and since the vaccination. The patient was recovering from the events.
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| 74 | 2021-01-26 | muscle pain |
tiredness for 6 hrs after receiving shot; muscle aches on arm receiving shot and slight headache nex...
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tiredness for 6 hrs after receiving shot; muscle aches on arm receiving shot and slight headache next morning.
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| 74 | 2021-01-27 | muscular weakness |
Lower leg weakness and tingling. Taken by ambulance to hospital. It was treated as an allergic react...
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Lower leg weakness and tingling. Taken by ambulance to hospital. It was treated as an allergic reaction and she was released the same day.
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| 74 | 2021-01-27 | neck pain, joint pain |
tired; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, up...
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tired; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; strong pain on her shoulder, upper arm, breast and neck area; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date not reported), via an unspecified route of administration in the right arm on 12Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history included anxiety (needed to calm down), blood pressure abnormal, blood cholesterol abnormal, rheumatism, and osteopenia; all were ongoing. Concomitant medications included losartan potassium for blood pressure abnormal, atorvastatin blood cholesterol abnormal, sulindac for rheumatism, carvedilol for blood pressure abnormal, alendronate sodium for osteopenia, and venlafaxine; all were ongoing. On 12Jan2021, the patient experienced strong pain on her shoulder, upper arm, breast and neck area. On an unspecified date, the patient was also tired. Clinical outcome of event tired was unknown while for the other events was recovered on 13Jan2021.
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| 74 | 2021-01-27 | neck pain, muscle tightness |
Pain (level 4 of 10) starting in right rear of neck, becoming more intense on 01/19/21. By evening h...
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Pain (level 4 of 10) starting in right rear of neck, becoming more intense on 01/19/21. By evening head movement was very difficult, I could not sleep in bed that night. I slept on the couch sitting up trying to immobilize head. During the night pain spread into the base of my skull. I applied heat to help relieve the pain and tightness. On 01/20/21 the pain (6 of 10) spread into the left side of neck and skull, it became difficult to eat, swallow and to get up from couch. I tried to sit motionless most of the day. On 01/21/21 the pain (6 of !0) moved down into my left rear shoulder, I continued to apply heat and immobilize sitting on couch, eating and swallowing still difficult. On 01/22/21 pain in neck and base of Additional information for Item 18: skull subside to level 5, movement of head still difficult, able to to get up and move slowly. Could not lift head to drink, still needed to use straw. Slept on couch again this night. On 01/23/21 pain still subsiding to level 4, head movement still difficult, still needed straw to drink, slept on couch again. On 01/24/21 pain continuing to subside to level 3, head movement still difficult, still needed straw to drink, slept on couch again. On 01/25/21 conditions unchanged. On 1/26/21 pain subsided to level 2, head movement stiff but not difficult, swallowing less difficult but still need straw to drink. Slept in bed for first time since 01/19/21. On 01/27/21 pain continued to subside to level 1, head movement improved but still limited, still need straw to drink, able to move around more freely but still not normal. Improvement is slow but I hope to be back to normal in a few days. I am concerned that my second vaccination may cause a more severe reaction, please have someone call or contact me so I can discuss this issue.
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| 74 | 2021-01-28 | joint pain, muscle pain | Chills, joint pain, no fever, muscle ache |
| 74 | 2021-01-28 | muscle pain |
Significant left-arm pain, fatigue, general muscle ache, nausea, headache, chills Began 12 hours aft...
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Significant left-arm pain, fatigue, general muscle ache, nausea, headache, chills Began 12 hours after vaccination Symptoms still present, but beginning to improve after 48 hours
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| 74 | 2021-01-30 | joint pain, muscle pain |
Next day: fever 100.2 Muscle aches, joint pain, nausea, fatigues, head ache all day thru early eveni...
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Next day: fever 100.2 Muscle aches, joint pain, nausea, fatigues, head ache all day thru early evening Day 2: no fever, joint pain, muscle aches, head ache and nausea all less then day before
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| 74 | 2021-01-31 | muscle pain |
Constant headache fever ( 99.7) chills achy muscles no appetite Feeling somewhat better 48 hours lat...
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Constant headache fever ( 99.7) chills achy muscles no appetite Feeling somewhat better 48 hours later -- but not all better
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| 74 | 2021-02-01 | joint pain, muscle pain, arthritis |
No energy has been really bad today; Tiredness; Headache; Muscle pain; Chills; Joint pain; Feeling u...
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No energy has been really bad today; Tiredness; Headache; Muscle pain; Chills; Joint pain; Feeling unwell; arthritis; she can't go to sleep until 1 am/unable to sleep/She can go to sleep at the drop of the hat in the afternoon which is not usual; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), intramuscular on 15Jan2021 14:15 at single dose on the left deltoid (also reported as "left arm") for COVID-19 immunization (reported as "Prevention"). Vaccination facility type was retirement community, not a military facility. Medical history included "blood pressure", reflux (her esophageal flapper bottom is deteriorated), blood disorder (reported as indication of aspirin: "blood thinner") and depression. Concomitant medications included acetylsalicylic acid (ASPIRIN [ACETYLSALICYLIC ACID) as a blood thinner, citalopram hydrobromide (CELEXA) for depression, hydrochlorothiazide for blood pressure, omeprazole for reflux (It is because her esophageal flapper bottom is deteriorated) and multivitamin; patient reported that she was taking all prior to the vaccine and did not think any were relevant to the report. There were no previous vaccine (reported as "Additional Vaccines Administered on Same Date of the Pfizer Suspect. None"). The patient reported that she got the injection last Friday (15Jan2021). She was still feeling the symptoms of everything with the exception of injection site pain and swelling and redness. She did not have any swelling of lymph nodes or nausea. With the exception of those items listed, she had all the other side effects. On 16Jan2021, the patient experienced tiredness, headache, muscle pain, chills, joint pain and feeling unwell. The patient stated that muscle pain and joint pain could also be attributed to arthritis. Patient mentioned that chills could have been Sunday, but she thought Saturday (16Jan2021). Patient did not have a fever. Patient also mentioned that unable to sleep was a chronic problem. She can go to sleep at the drop of the hat in the afternoon which was not usual. Then at night, she could not go to sleep until 1 am. She did not wish to list this as a side effect and did not feel it was attributed to the vaccine. No energy has been really bad today (19Jan2021), but she still thinks it was persistent. Patient will get another dose in 3 weeks. No emergency room (ER) or physician's office required. Patient wanted to know if it was common to get these side effects. Outcome of the events tiredness, headache, muscle pain, chills, joint pain, feeling unwell and No energy was not recovered while for other events was unknown. There was no investigation assessment. Information on the lot/batch number has been requested.; Sender's Comments: The reported insomnia is considered unrelated to BNT162B2 administration since mentioned as a pre-existing condition
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| 74 | 2021-02-01 | joint pain |
Day 1-3 severe chills, severe headache, tired, joint pain/body aches, temp >101 Day 3-6 or 7 sore th...
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Day 1-3 severe chills, severe headache, tired, joint pain/body aches, temp >101 Day 3-6 or 7 sore throat, nausea, vomiting, diarrhea, altered taste Also complaint of intermittent acute shortness of breath and cough
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| 74 | 2021-02-02 | joint pain |
6 hours after vaccination, patient reported hives all over her body. She took Benadryl by mouth and ...
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6 hours after vaccination, patient reported hives all over her body. She took Benadryl by mouth and applied Benadryl cream. She also reported joint pain. Next morning, hives were slightly better but not gone so patient took more benadryl. Patient also reports feeling a little dizzy this morning especially when she turns around.
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| 74 | 2021-02-02 | joint pain |
Patient reported having hives all over body starting 6 hours after vaccination. Patient to Benadryl ...
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Patient reported having hives all over body starting 6 hours after vaccination. Patient to Benadryl by mouth and applied topically. Patient also reported joint pain. Next morning after vaccination, patient said hives were maybe better but about the same. She took more benadryl. Patient also reports some dizziness this morning
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| 74 | 2021-02-02 | flank pain |
Was fine the day of receiving vaccine. The next morning when woke up, was unable to move legs. State...
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Was fine the day of receiving vaccine. The next morning when woke up, was unable to move legs. Stated could not get out of bed, could not walk, has severe weakness. flank pain, nausea, headache, fever, and chills
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| 74 | 2021-02-02 | muscle pain, joint pain | Chills. muscle ache, joint pain, rash at injection site, extremely tired |
| 74 | 2021-02-03 | musculoskeletal stiffness |
Began to get a stiff neck 5 days after vaccine was administerd. Excruciating pain the next day. Cou...
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Began to get a stiff neck 5 days after vaccine was administerd. Excruciating pain the next day. Could not get out of bed or bend over without supporting my head with my hands. Sought chiropractic and massage therapies on the 7th and 8th days. Beginning to get better, but still hurts. I can't say for certain that the vaccine caused this, but since I was not in an accident and had not fallen, I can't find another reason to have had such an excruciating condition.
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| 74 | 2021-02-04 | joint pain |
First dose : Second day of vaccination very mild fatigue , moderate pain in arm Second dose : ...
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First dose : Second day of vaccination very mild fatigue , moderate pain in arm Second dose : pain in the arm began the day of vaccination, second day at noon began chills, fatigue, joints pain and and fever at around 4 pm , highest reading 100.4 Third day feeling good for
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| 74 | 2021-02-05 | joint pain, bone pain, muscle pain |
About 3-4 hrs. after 2nd Covid vaccine, sore arm. Next day: sore arm, bones ached, injection site p...
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About 3-4 hrs. after 2nd Covid vaccine, sore arm. Next day: sore arm, bones ached, injection site pain and swelling, muscle and joint pain, feeling unwell
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| 74 | 2021-02-05 | muscle pain |
I have had a ache in my bycept for over a week/ it began a week after the vaccination. Not real se...
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I have had a ache in my bycept for over a week/ it began a week after the vaccination. Not real serious but I am concerned about getting the second shot next week
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| 74 | 2021-02-05 | muscle pain | Unable to lift arm and soreness. Flu like symptoms - muscle aches, chills, headache |
| 74 | 2021-02-06 | musculoskeletal stiffness |
From the point of injection in the left deltoid down to the elbow the arm was red, hot, stiff, and s...
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From the point of injection in the left deltoid down to the elbow the arm was red, hot, stiff, and swollen. Patient reported pain as well as itching in the swollen part. Arm was also bruised the size of a half dollar at the injection site. Dr. diagnosed her with cellulitis after immunization and prescribed her amoxicillin 875mg twice daily for 10 days.
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| 74 | 2021-02-07 | back pain, grip strength decreased, muscle pain, joint pain |
Couldn't hold a cup to drink; Pharangitis; Couldn't get warm; Strange odor in her nose, like burning...
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Couldn't hold a cup to drink; Pharangitis; Couldn't get warm; Strange odor in her nose, like burning plastic; Taste started to diminish; Painful bilateral lower back pain; Cough/Dry cough; Bad headache; Severe shaking chills; Muscles and joints ached; Muscles and joints ached; This is a spontaneous report from a contactable nurse (patient). A 74-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration at left deltoid on 20Jan2021 at 9:30-9:45 am at SINGLE DOSE for COVID-19 immunization. Medical history included exposure to radiation from 2017 to an unknown date and did lose some of her sense taste due to 2 massive doses of radiation in 2017). There were no concomitant medications. Historical vaccine included two doses of shingles vaccine (SHINGRIX) for Immunization and experienced shaking, chills, and muscle and joint pain after the vaccine. The patient experienced bad headache (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, Severe shaking chills (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, muscles and joints ached (disability) on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, couldn't hold a cup to drink on an unspecified date with outcome of unknown, painful bilateral lower back pain on 20Jan2021 17:00 with outcome of recovered on 21Jan2021, cough/dry cough on 20Jan2021 17:00 with outcome of not recovered (reported as worsened), strange odor in her nose, like burning plastic on 21Jan2021 with outcome of not recovered, taste started to diminish on 21Jan2021 with outcome of not recovered, pharangitis on an unspecified date with outcome of unknown, couldn't get warm on an unspecified date with outcome of unknown. Details were as follows: the patient received the COVIED in the morning of 20Jan2021. By 5pm she had developed a headache, severe shaking, chills, muscle and joints pain, severe lower back pain, and a dry cough; she was miserable. A few years ago after her double dosing of the shingles vaccine she had a similar reaction of shaking, chills, and muscle and joint pain. She has no product details for that product, no NDC, Lot, or expiry to provide. The patient confirmed that the shingles shot was 2 doses, not a double dose given at one time. When asked a seriousness criteria it was explained that the symptoms that started on the 20th, she felt they were disabling. She couldn't get warm, stop shaking, couldn't hold a cup and the pain was severe and she has high tolerance for pain. By around 3pm that day on the 21Jan2021 everything but the dry cough had resolved, and that had gotten worse. She also developed new symptoms. She had strange odor in her nose, like burning plastic and her sense of taste started to diminish. She did lose some of her sense taste due to 2 massive doses of radiation in 2017, She has no product information, NDC, Lot or Expiry for that radiation but after that she did have taste, some of it did come back. On the 21Jan2021, it was less, the sense of taste and now today she has no taste at all. For the muscle and joint pain she took Aleve. She was told if she was feeling worse over the weekend to go to the ER or urgent care. The patient was wondering and thinking this was her normal response to the vaccine just like she had a normal response that shingles vaccine.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 74 | 2021-02-07 | muscle pain, joint pain |
Start of an ear infection; Stuffy nose; Sore throat; Headache; Muscle and joint pain; Muscle and joi...
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Start of an ear infection; Stuffy nose; Sore throat; Headache; Muscle and joint pain; Muscle and joint pain; Chills; Dry mouth; White coating all over tongue; Nausea; Unbelievable thirst; Slight swelling at injection site; Injection site pain; Tiredness; swollen tonsils; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1283), via an unspecified route of administration in the right arm on 13Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included Transverse Myelitis ongoing from 2016, neurologic lime disease ongoing from 1992 due to which the patient gets migraines (from 1992), H. Pylori in May2019 and the patient is hard of hearing, ongoing from an unknown date. The patient's concomitant medications included unspecified migraine medication. On 13Jan2021 the patient experienced injection site pain, slight swelling at injection site, tiredness, and unbelievable thirst. On 14Jan2021 the patient experienced headache, muscle and joint pain, chills (which come and go), nausea (which is off and on), dry mouth, and white coating all over tongue. On 15Jan2021 the patient experienced stuffy nose and sore throat. The patient stated she still has tonsils on her right side where she has the earache and they are swollen (from an unknown date in Jan2021). On 17Jan2021 the patient experienced start of an ear infection (earache on the right side). The patient has had no fever and no redness. The patient stated she knows injection site pain is standard for a lot of people. The patient stated on Monday, 18Jan2021 she saw her provider and went over some of this. She stated she would not think that 4 days later she would still be feeling the side effects. The patient was inquiring if this only occurs with the first dose or will it also occur with the second? She is scheduled for the second one on 05Feb2021. The patient asked what was the time frame between injections? The patient was treated for the ear infection Neomycin/Polymyxin Sulfate ear drops and for the tiredness she has been walking around and trying light exercises. The patient turned down other medication as she did not want it to have any effect with the vaccine. The patient asked if there were any recommendations for the nausea and headaches. She stated she does have her migraine medication which she is trying to use to deal with the headaches. The clinical outcome of the injection site pain and slight swelling at injection site was recovered on 14Jan2021 and the white coating all over tongue recovered on 18Jan2021. The clinical outcome of the tiredness and start of an ear infection was recovering. The clinical outcome of the headache, muscle and joint pain, chills, nausea, stuffy nose, sore throat, thirst, and dry mouth was not recovered. The clinical outcome of the swollen tonsils was unknown.
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| 74 | 2021-02-07 | muscle pain |
feeling icky all day; Rash on front and back of nect; chest, and little bit down both arms; Muscle a...
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feeling icky all day; Rash on front and back of nect; chest, and little bit down both arms; Muscle aches; This is a spontaneous report from a contactable consumer(patient).A 74-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3246), via an unspecified route of administration on 12Jan2021 16:45 at single dose, left upper arm for COVID-19 immunization. Medical history and concomitant medications reported as none. The patient had a little bit of muscle aches on 12Jan2021 after the vaccine kind of all day. Other days it came and went. On 19Jan2021 the patient felt icky all day. She got a rash on the front and back of her neck. Rash was also on her chest and a little bit down both arms. She went to a walk-in clinic. Wasn't sure if it would be related to the COVID-19 Vaccine, but was advised to report it. Events required a visit to walk-in clinic. The outcome of the events was unknown.
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| 74 | 2021-02-08 | joint pain, muscle pain | Joint and muscle pain, fatigue |
| 74 | 2021-02-09 | muscle pain | Extreme fatigue, extreme dizziness, loss of appetite, fever of just over 102, muscle ache |
| 74 | 2021-02-10 | back pain |
she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; she had a cut to...
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she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; right breast hurts; it radiates around to her back; Fatigue; and can't lift or pull anything and it really, really hurts; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included sinus disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received a flu shot on an unspecified date. Consumer is calling about the Pfizer COVID-19 vaccine, and says she just spoke to a nurse who told her to call and find out if her experience for what she had after her first shot on Friday of the past week had been reported before. She says that on Saturday (23Jan2021), she woke up and her right breast hurt, there is something in there, it radiates around to her back, along with having fatigue. She says she was told to see if anyone else reported this, she expected normal stuff like, flu stuff, this is not that. She says she is on her way to urgent care to have that looked at. She asks if condition persists, she is supposed to get her second dose on 12Feb, does she get it? She got her first dose last Friday (22Jan2021) then woke up Saturday and can't lift or pull anything and it really, really hurts. She says to add to this, which she talked to two doctors (docs) who said it was unrelated, that night she had a cut to the top of the roof of her mouth that had uncontrollable bleeding, she went to the emergency room for that and got a shot to help her coagulate blood, and will be seeing an ENT so hopefully that will be under control. No further details provided about shot to help her coagulate blood. She got the flu shot but that was Thanksgiving, way back, not recent. She is going to get her sinuses checked out, they did a CAT scan yesterday, and is going to the doctor for that 1Feb. She is concerned that the breast pain started last Saturday and is still really painful, she doesn't know why all of a sudden that happened, so she is going to the urgent care to see if they can do something for it, and will be getting an appointment with her OBGYN. For her right breast hurting, she took Tylenol and Ibuprofen, that is all she has done. Tylenol, LOT: PPAO33, EXP: Sep2022. Ibuprofen, LOT: 113132. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on 27Jan2021. Therapeutic measures were taken as a result of she had a cut to the top of the roof of her mouth that had uncontrollable bleeding she had a cut to the top of the roof of her mouth that had uncontrollable bleeding and right breast hurts. The outcome of the events was unknown.
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| 74 | 2021-02-12 | joint pain |
Rash/welts developed over entire body (face, trunk, arms and legs) within 1 hour of receiving vaccin...
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Rash/welts developed over entire body (face, trunk, arms and legs) within 1 hour of receiving vaccine. Itching started that evening. Next day went to PCP who ordered 3 doses of prednisone 20mg and benadryl 25mg every 6 hours PRN. Day 2, rash/welts increased as well as itching. Evening of day 2, rash to legs progressed to purpura, temp of 102.7, chills and extreme pain to bilateral hips which prompted taking to ED and being admitted to progressive care unit.
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| 74 | 2021-02-13 | muscle pain, neck pain |
On the Day after vaccine 2/6/21 was extremely tired with muscle soreness at back of neck. On 2/8/21,...
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On the Day after vaccine 2/6/21 was extremely tired with muscle soreness at back of neck. On 2/8/21, 2/9/21, 2/10/21 & 2/11/21 & 2/12/21 shortness of breath and the slightest physical effort. Very weak and fatigued. On 2/10/21 Went to the Doctor blood hemoglobin went down to 6.3. {Just had a blood transfusion on Jan 22, Hemoglobin was 6.6 that day) The Doctor prescribed another transfusion that took place on 2/12/21.
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| 74 | 2021-02-16 | joint pain |
Noted angry red rash on bilateral Achilles heels on 1/30/2021. Rash was very red and itchy. Tx with...
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Noted angry red rash on bilateral Achilles heels on 1/30/2021. Rash was very red and itchy. Tx with Benadryl 25 mg 2-3 times a day and Hydrocort 10 cream as needed. This lasted approximately 1 1/2 weeks. I woke up on 2/13/2021 with pain in both wrist joint, all my finger joints as well as swelling so that I couldn't close my fingers. This is still going on. Today (2/17/2021) I noted joint pain in both my knees and shoulders. I have not had any problem with either my knees or shoulders prior to this.
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| 74 | 2021-02-17 | joint pain, muscle pain |
3 hours after injection, I noted sensation of throat tightening (no breathing problems) and headache...
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3 hours after injection, I noted sensation of throat tightening (no breathing problems) and headache, throat symptoms eased after an hour. Few hours later I noted gradual increase in muscle and joint ache, no increase in body temp. and sudden onset of fatigue. I am a very active person - playing tennis 3 - 4x/wk, hiking 4 - 6 miles twice a week, biking, dancing, etc. Most symptoms subsided within 24 hours, but fatigue still persists on the third day following the injection. Had to stop normal activity, less fatigue but still need to stop after 20 minutes of standing or walking to sit and rest,
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| 74 | 2021-02-17 | joint pain |
1) HEADACHE, NAUSEA , FATIGUE - STARTED ABOUT 7:00PM ON 2/16 LASTED ABOUT 2 HOURS 2) ARTHRITIS FLARE...
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1) HEADACHE, NAUSEA , FATIGUE - STARTED ABOUT 7:00PM ON 2/16 LASTED ABOUT 2 HOURS 2) ARTHRITIS FLARE UP - WORSE ARTHRITIS PAIN EVER, OCCURED ABOUT 9:00PM ON 2/16, LASTED ABOUT 2 HOURS 3) SLIGHT SORENESS AT INJECTION SITE ON 2/17 IN MORNING
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| 74 | 2021-02-18 | neck pain |
Day 1: pounding headache, radiating pain from top of head down the neck on the left side (pain scale...
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Day 1: pounding headache, radiating pain from top of head down the neck on the left side (pain scale 3-4) Day 2: pain on left side of head and neck intensifies to an 8-9 (treatment: ibuprofen), loss of mobility in face. (PCP emailed with no immediate response) Day 3: full loss of mobility and control on entire left side of face. Emergency room visit diagnosis: Bell's Palsy. Head neck pain persist (no more ibuprofen taken because of stomach pain) ER doctor prescribes 5 day course of Prednisone. Day 4-7: Bell's Palsy symptoms persist unchanged. (Treatment: Acupuncture, 2 visits) Pain on left side of head neck persist at a pain scale of 2-3.
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| 74 | 2021-02-21 | back pain, neck pain |
Cold chills,bad headache and lower back and neck ache/pain from 12:30 on the 18th till 19th then co...
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Cold chills,bad headache and lower back and neck ache/pain from 12:30 on the 18th till 19th then cold chill stopped back and head ache pain continues till Saturday 20th am Tylenol was taken didn't help much I continue to get slight headache as of today 22nd Monday fine now except slight head and back pain
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| 74 | 2021-02-24 | facial discomfort |
on 2/24/21 noted discomfort starting on scalp on top of head going down to left eyebrow, onto left o...
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on 2/24/21 noted discomfort starting on scalp on top of head going down to left eyebrow, onto left orbit down face on left side of nose, also a fever blister on bottom lip starting 2/22/2021,discomfort continues. have not called M.D. Lysine ointment on lip. no other treatment
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| 74 | 2021-02-24 | muscle pain, joint pain |
Feb. 19 upon going to bed about 10:00; muscle aches in shoulders, arms, legs, knees. Feb 20 upon wak...
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Feb. 19 upon going to bed about 10:00; muscle aches in shoulders, arms, legs, knees. Feb 20 upon waking about 5:00AM; headache, continuation of pain muscles and joints, fever 101.3. Feb22 I don't know if related to vaccine, but fever blisters.
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| 74 | 2021-02-25 | joint pain | Painful shoulder and arm continues still, one month later |
| 74 | 2021-02-25 | back pain |
still a part of her forehead that feels like a live nerve; upper back started hurting/back was very ...
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still a part of her forehead that feels like a live nerve; upper back started hurting/back was very tender and sensitive around the spine area; arm was a little sore; pharmacist had some left over in the vial and gave her that; has post traumatic neuralgia" related to her shingles; Shingles; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 29Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from two contactable consumers via medical information team. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date: unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. Medical history included dental work/specifying a tooth being pulled and an implant (an antibiotic (Amoxicillin)) was used and shingles (7 years ago). The patient's concomitant medications were not reported. It was reported that Pharmacist had some left over in the vial and gave the patient on 28Jan2021. Patient wanted to make sure it was ok. Patient stated "she got shingles on her face, 7 years ago, and had recent dental work done," specifying a tooth being pulled and an implant. She stated she received the first dose of the COVID-19 vaccine last Thursday evening (28Jan2021). On 29Jan2021 and 30Jan2021 (friday and saturday), she mentioned, her "arm was a little sore". On 30Jan2021 and 31Jan2021 (saturday evening and sunday morning) she said her "upper back started hurting" and thought "maybe [she] sat on the couch for too long". On 31Jan2021 (Sunday evening), she added her "back was very tender and sensitive around the spine area" therefore, she "took some tylenol and used a heating pad thinking [she] pulled a muscle". On 01Feb2021 (By Monday) she said her "the back and front were very sensitive" to the point where: when she "touched [her] skin it felt like [she] was touching some live nerves". She explained seeing a physician assistant who "couldn't figure out what was going on" and since it seemed to be getting worst, she thought she could possibly have Shingles. She continued saying she then "went to see an orthopedic doctor who took x-rays and said he doesn't see anything, and it may be the beginning phases of Shingles". She mentioned she has an appointment with her internist today at 4:20. She later mentioned her "brother, who is a doctor, thinks [she] has post traumatic neuralgia" related to her shingles on an unspecified date in Jan2021. She then added there is "still a part of her forehead that feels like a live nerve" to touch, since having Shingles, on 01Feb2021. The outcome of the events was unknown. The outcome of the events was unknown. The information on the Batch/Lot number has been requested.
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| 74 | 2021-02-25 | muscle pain | Sore arm headache muscle aches fever chills |
| 74 | 2021-02-27 | joint pain | Chills 2nd day: Sciatica seizing up hips area. Joint pain in both knees |
| 74 | 2021-02-27 | muscular weakness |
Tested positive for COV2T antibodies on 1/18/2021. Starting 1/31/21: Severe fatigue; loss of muscle ...
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Tested positive for COV2T antibodies on 1/18/2021. Starting 1/31/21: Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash. Treatment - bed rest. Outcomes - OK after 4 days.
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| 74 | 2021-02-27 | muscular weakness |
Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash....
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Severe fatigue; loss of muscle strength; loss of energy; chills; occasional tremors; full-body rash. Treatment - bed rest. Outcomes - OK after 4 days.
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| 74 | 2021-02-28 | back pain |
At 10am on Thursday February 25, I SUDDENLY experienced the onset of violent chills, shaking so hard...
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At 10am on Thursday February 25, I SUDDENLY experienced the onset of violent chills, shaking so hard I couldn't initially place a thermomenter in my mouth. Moments later, this was accompanied by throbbing pain in my lower back. Eventually I was able to take my temperature and I had fever. My daughter contacted my primry care physician who told us to go the emergency room. By the time we went to hospital, the chills had stopped as well as the lower back pain. I was quarantined (though they knew I had been vaccinated for COVID) until they tested me for COVID, the test came back negative in an hour. They did a number of tests and I was discharged around 6:00 pm that evening
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| 74 | 2021-02-28 | muscle tightness |
Approximately 10 minutes after receiving the vaccine, patient reported muscle tightness up through h...
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Approximately 10 minutes after receiving the vaccine, patient reported muscle tightness up through her left shoulder into her neck. She was extremely anxious. Her initial blood pressure was 190/100. She reported being extremely scared of coming to the clinic today for the vaccine and that she got no sleep the night before. We talked extensively and I tried to get her mind thinking about anything else possible. Repeated her BP after a time and it was 142/82. Once her required 15 minute observation was over, she requested to leave, because part of her apprehension was just being there. Her neck tightness has subsided.
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| 74 | 2021-02-28 | musculoskeletal chest pain, muscular weakness |
L arm weakness, pain, L anterior Chest wall tenderness onset later that afternoon. worse with moveme...
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L arm weakness, pain, L anterior Chest wall tenderness onset later that afternoon. worse with movement, couldn't get dress herself afterwards
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| 74 | 2021-03-01 | arthritis, joint pain |
With the first vaccine on 1/29/21 I feel slight soreness at injection site and itching all over abou...
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With the first vaccine on 1/29/21 I feel slight soreness at injection site and itching all over about eight hrs after which lasted a day. With the second vaccine on 2/16/21 I felt itching after about six hours for a day and took Benedyl and tylenol. In the 21th I began to be sore all over, my knees, back, shoulders, ached and it was painful to rise from a seated position. It was all my joints were inflamed. I did not have a temperature, my blood pressure went down to 119/55. I am taking warm baths, tylenol, and waiting for the pain to subside. I also feel fatigued. I will call my primary Doc if I don't continue to improve.
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| 74 | 2021-03-01 | joint swelling |
With first shot, mild itching all over. One Day. With second shot on 2/16- itching, took Benedyl an...
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With first shot, mild itching all over. One Day. With second shot on 2/16- itching, took Benedyl and tylenol. On 21st sore all over, knees, back, shoulders, difficulty rising from seated position. It was as if all my joints were inflamed. Had strange bruise of left thigh, Dificulty walking. Took warm bath, muscle rub, ibuprofin, Pain continued on 10.,muscle spasms. When to ungent Care 2/27. Test Netrophils 61.7,lymphs 30.0, monos 6.0, eos,2.1 baso 0.2, AnC 2.99;Lymphs 1.45, monos 0.29, eos auto 0.10,BASO,001, WBC 4.8, RBC 4.70. HGB 12.7 HCT 39.8, MCV 84.7,MCHC 31.9.RDW<BLOOOD, 14.0,PLT'S AUTO,NA 141, K 4.1,CL 103, CO2 29. CREAT 0.86, GFR 77, BUN 15 , GLUC 112, ESR 23
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| 74 | 2021-03-01 | muscle pain |
sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass ou...
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sweating; Chills; AFIB; Heart rate racing; Lightheadedness and dizzy and felt like she would pass out.; Nausea; Muscle ache; Headache; Second dose arm hurt at injection site; compromised immune status; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), intramuscular at arm left on 13Feb2021 at 10:30 (at the age of 74 years) at single dose for COVID-19 immunization. Medical history included primary biliary cholangitis (PBC, autoimmune condition and was diagnosed 10 years ago), diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, diabetes and obesity, all from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), intramuscular at arm left on 24Jan2021 and experienced sore arm. The patient experienced headache and arm hurt at injection site, both on 13Feb2021 at 19:00; heart rate racing, AFib, lightheadedness and dizzy and felt like she would pass out, all on 14Feb2021 at 07:30; nausea, muscle ache, both on 14Feb2021 at 03:00, chills on 14Feb2021 at 15:00 and sweating on 14Feb2021 at 16:00. The patient outcome of the events was recovering.
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| 74 | 2021-03-03 | joint pain, muscle pain, weight decreased |
4 weeks severe out of control pains , myalgias, arthralgias, weight loss, thrombocytopenia, anemia, ...
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4 weeks severe out of control pains , myalgias, arthralgias, weight loss, thrombocytopenia, anemia, elevated inflammatory markers. currently improving on prednisone.
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| 74 | 2021-03-03 | armpit pain |
Swelling; Redness moved from actual site down my arm about 6 to 7 inches; Hot to touch area on right...
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Swelling; Redness moved from actual site down my arm about 6 to 7 inches; Hot to touch area on right arm; A little headache at the back of the head; Itching; More pain when l lift my arm, my arm pits/Hurting under her arm when she was lifting; Swollen glands; My temperate was 100.8; had difficulty lifting her right arm; Tired, very tired; Tenderness at vaccinate site; More pain when l lift my arm, my arm pits/pain in arm/pain in her right arm/a lot of pain; I feel tugging and redness when I raise my arm, It's not red its blotchy; I feel tugging and redness when I raise my arm, It's not red its blotchy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscularly at site of right arm on 28Jan2021 at single dose for COVID-19 immunisation. Medical history included (synthroid: Taking for years), prevent urinary tract infection (UTI) (methenamine: started a year and a half ago), vitamin supplementation (Preservision Areds 2 eye vitamins more than a year ago; Vitamin C with Zinc 8-9 months ago), dry eyes (Thera tears: dry eye therapy. she has not been consistent with taking), cholesterol (simvastatin: taking 20 years or more), allergic to Sulfa Drugs and Tetracycline, obesity (had been fighting it for 30 years), removed polyps (had a flat polyp that was a little more dangerous the first time and it was removed; non-cancerous), got the flu (08Jun months later, got the flu, went to the hospital and developed PNA) and eczema (took calcium 1200mg). Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid; methenamine for prevent UTI; ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2) for vitamin supplementation; ascorbic acid, zinc (VITAMIN C WITH ZINC) for vitamin supplementation; carmellose sodium (THERA TEARS) for dry eyes; simvastatin for cholesterol; calcium for eczema. The patient previously took Flu vaccine (Injection site was left arm, intramuscularly) in Oct2018 and experienced pain in injection site and redness in arm; took the first dose of BNT162B2 with lot number: EL3246, intramuscularly in left arm site at 09:00 on 08Jan2021. Clinical course: After the second dose of vaccination, patient noticed tenderness at vaccinate site at 13:00 and had pain in arm on 28Jan2021, but on 29Jan2021, the pain was worse, and she had difficulty lifting her right arm at 16:00. On 30Jan2021, she started noticing more pain when she lifted her arm, her arm pits, it was hurting under arm when she was lifting. She thought maybe there were swollen glands but did not feel it. her temperate was 100.8, and she took some paracetamol (TYLENOL), by the evening, her temperature was at 98.6 normal. On 31Jan2021, she noticed a lot of pain, itching and redness, redness moved from actual site down her arm about 6 to 7 inches at 14:00. The pain in her right arm was not as bad as it was, but the redness in the area and itching was there, it was hot to touch area on right arm, and she tried cold compresses and took paracetamol. Also, it was hurting under her arm when she was lifting. She experienced something like that before with a Flu vaccine. She noticed when she looked it up, the information states, yes. And it was still going on today, not so much pain, just swelling and redness, looked like what Moderna calls a covid arm. She had no temperature, a little headache on 31Jan2021 at the back of the head and tired, very tired, she was tired from 29Jan2021, and was better from 01Feb2021. She took paracetamol last night, and cold compress. she used to take baby aspirin; she didn't know if it would be a problem. She read not to take paracetamol or ibuprofen before vaccination. She felt tugging and redness when she raised her arm, it was not red its blotchy. She didn' t feel any swelling. The last 7 to 8 months, she was running high blood counts, 12.3 (high) and she had no infection, her doctor was a little nervous, the last one on 15Jan2021, it was down to 10.2 within normal range. Her immune system was very active. She had a flu shot in Oct2018 at age of 72 y/o and by 08Jun months later, she got the flu. She went to the hospital and developed PNA. In 2019 and again this past Aug2020, she had a Colonoscopy where they removed polyps. She had a flat polyp that was a little more dangerous the first time and it was removed. It was non-cancerous. The doctor was just watching it. Last blood results were 2 weeks prior to having first shot on 15Jan2021. The only thing that showed was her Liver enzymes were a little elevated. She was told that if she hadn't gotten the vaccine, it would have been worse, her doctor gave me the zpack. They were calling it a subcutaneous sensitivity, she had eczema, she forgot to mention that. She was taking calcium 1200mg, she forgot to tell her that also. The outcome of events pain in arm, redness and feeling hot was not recovered; of events tiredness, body temperature increased, itching and headache was recovering; of rest events was unknown.
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| 74 | 2021-03-04 | joint pain, muscle pain |
Almost threw up last night; joint pain; Few little odd pains; soft pain that make her feel weak and ...
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Almost threw up last night; joint pain; Few little odd pains; soft pain that make her feel weak and then go away; Nauseous; No dizziness, but unsteadiness; Tired; Headaches; began to feel a little bad/ generally didn't feel well/Malaise; Feels like the stomach flu; Weak; Gentle muscle ache; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via an unspecified route of administration on 28Jan2021 15:30 in left arm at single dose as Covid vaccine, etanercept (ENBREL, 50 mL/mg, Solution for injection in pre-filled pen, lot number: 1119808, expiry date: Apr2023) via an unspecified route of administration from an unspecified date and ongoing at 1 DF weekly to the stomach area for rheumatoid arthritis, methylprednisolone (MEDROL, tablet) oral from an unspecified date and ongoing at 3 mg, daily (1.5 tablets daily for total of 3 mg) for rheumatoid arthritis, methotrexate (tablets) oral from an unspecified date and ongoing at 20 mg, weekly (2.5 mg tablets, 20 mg total) for rheumatoid arthritis. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic or chromosomal abnormalities, endocrine abnormalities (including diabetes and obesity) and took levothyroxine, rheumatoid arthritis. She had had regular blood work for rheumatoid arthritis and that was normal for her, they were relatively normal and her ESR was down. No additional vaccines administered on same date of BNT162B2. No other vaccines given the same day or 4 weeks prior. The patient's concomitant medications included levothyroxine daily for endocrine abnormalities. It was a daily thing for the body and the body couldn't live without it if it did not have it. The patient previously took the Shingrix vaccine and it was terrible for her and put her into a rheumatoid arthritis flare and was taking prednisone and was getting better and the wap she was in a rheumatoid flare. No prior vaccinations received within 4 weeks prior to the first administration date of the suspect vaccine. The patient was taking 3 medicines for rheumatoid arthritis that might or might not affect the RNA in the vaccine. She wondered if etanercept would have an effect on the vaccine since it was shipped on ice overnight. She did not think they would affect anything. Nobody has said anything about the medications and she just wanted to get the vaccine. Her doctor knows nothing about the interactions and none of them seem to know if it is normal to have these symptoms 4 days after getting the vaccine. She felt great the first 2 days after getting the vaccine and then began to feel a little bad. She was having some symptoms maybe 4 days on 01Feb2021 after receiving the Covid vaccine and wanted to know if that was sort of normal. It was unusual for her, but she had nauseous, not dizziness, but unsteadiness, tired, also headaches and generally didn't feel well. She felt like she might have the stomach flu, but had not had that in so many years. She also felt weak. No temperature. Gentle muscle ache. On 01Feb2021 Monday night she had the nausea. On 02Feb2021 Tuesday, she had it again, and had it again today and almost threw up last night. Just the malaise or tiredness had gotten worse. She could not tell the difference between the rheumatoid arthritis, joint pain and muscle pain and this with the vaccine. She was having a few little odd pains, but nothing that she hadn't had before. It was more of a soft pain, they made her feel weak and then they went away. It was more muscle than joint. The events did not require a visit to emergency room or physician office. She was supposed to get a second dose but felt she shouldn't, it might put her back into a rheumatoid flare. She was just getting over it and afraid to go through that with the Covid vaccine also. The action taken in response to the events for etanercept, methylprednisolone and methotrexate was dose not changed. The outcome of events nausea, unsteadiness, tired (tired was reported as worsened), generally does not feel well, feels like the stomach flu, weak, few little odd pains; soft pain, joint pain was not recovered, of other events was unknown.
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| 74 | 2021-03-04 | joint pain |
Felt like the flu that night & all the next day. Achey, painful joints, off-balance slightly, chill...
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Felt like the flu that night & all the next day. Achey, painful joints, off-balance slightly, chills, no fever that i know of, headache, extremely painful left arm up & down, into shoulder & scapula. . Stayed home all day., took Tyleno, benedril dye free the day after injection when feeling so bad
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| 74 | 2021-03-04 | joint pain | Joint pain mild headache |
| 74 | 2021-03-04 | muscle pain | Low grade temperature, muscle aches, fatigue, mild headache. |
| 74 | 2021-03-04 | muscle pain |
2nd Shot, 2nd day headache, bad muscle ache, third day slight headache redish injection site, fourth...
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2nd Shot, 2nd day headache, bad muscle ache, third day slight headache redish injection site, fourth day bad headache, indigestion and bad diarrhea. Injection site large red, purple, orange (size 2-1/2 " x 1-1/2" very sore. Today, 3/5; reaction site sore but brusing fading. Feel good. 1st Shot was slightly sore arm. Never had fever, cough, chills or vomitting. *** DID NOT CONTACT DOCTOR; WAS NOT EMERGENCY. Just felt like I had flu but thought I should report bad arm reaction.
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| 74 | 2021-03-06 | joint pain |
EAR ACHE PAIN, JOINT PAIN, UPSET STOMACH, HEAD ACHE, CHILLS, SINUS. NO TREATMENT AND NO OUTCOMES!...
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EAR ACHE PAIN, JOINT PAIN, UPSET STOMACH, HEAD ACHE, CHILLS, SINUS. NO TREATMENT AND NO OUTCOMES!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! WHERE DO I GET THE TREATMENT???????????????????????????????????
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| 74 | 2021-03-06 | muscle pain |
Muscle pain in right upper leg, groin, side and front of leg. Enough pain that I am limping when I ...
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Muscle pain in right upper leg, groin, side and front of leg. Enough pain that I am limping when I stand up and can't walk very far, due to the pain. It's been going on for 12 - 13 days and is not improving. I had no leg injury that I could identify as the source of the pain.
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| 74 | 2021-03-07 | muscular weakness | Dizziness, weakness in legs (sporadic but has gone on for 10 days) |
| 74 | 2021-03-07 | muscle pain |
strong chills, low fever, nausea and some vomiting, muscle aches, fatigue for the whole day after va...
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strong chills, low fever, nausea and some vomiting, muscle aches, fatigue for the whole day after vaccine. Fatigue the second day after vaccine. Okay now (3rd say after vaccine)
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| 74 | 2021-03-08 | joint pain | onset 3/1/2021 disabling pain in 3 arthritic areas simultaneously without prio overuse |
| 74 | 2021-03-08 | back pain | I had a very ,very bad back pain ,i couldn't move started 3/4 hours after vaccine |
| 74 | 2021-03-08 | muscle pain |
pt stated a few day after getting the vax she developed headache, muscle aches and pain, nauseated, ...
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pt stated a few day after getting the vax she developed headache, muscle aches and pain, nauseated, swollen lymph nodes, chills, dizziness, weakness, and had anxiety. Pt called ambulance and transported to ER. She was tested for covid w/ negative results. Had blood work w/ abnormal results (mild leukopenia). She was prescribed Benadryl. Her DX ; Dizziness, uncertain, mild medication reaction to the Covid vax. She was released and told to FU w/ PCP. Her FU appt is 3/12/2021.
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| 74 | 2021-03-09 | muscular weakness |
11:00 pm - ish: Site of injection began burning which became more intense throughout the night. Cold...
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11:00 pm - ish: Site of injection began burning which became more intense throughout the night. Cold sweats, severe aching and muscle weakness especially in legs, nauseous, severe headache. I tried to drink a little water. Didn't have enough energy and was too cold to get up to get any medication. Slept a little. I was awake early in the morning, but too cold to get out of bed. At 8:30 a.m. I got up and could hardly walk. Dizzy, muscle weakness as if muscles had turned to Jell-O.. Sat down and threw up, mostly dry heaves, which lasted a few minutes. Fitful sleep until 11:00 a.m. when I began to feel better. Drank more water and just rested for a few hours. I ate some applesauce and made a batch of white rice which I ate around 6:00 p.m. Achiness in lower extremities continued until bedtime (10:00 p.m.) when I took a Meloxicam (15 mg) which my GP prescribed for achiness in my neck due to arthritis. I take this drug only when needed and thought it would help the aching in my legs. Maybe it did...maybe it was a coincidence that the achiness was alleviated enough for me to go to sleep. I am almost 100% today. It takes a little longer at my age to fully recover from any illness however slight. I would like to add that I am grateful to be vaccinated.
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| 74 | 2021-03-10 | limb discomfort | discomfort in arm for two days, minor headache one day, felt tired for approximately six days. |
| 74 | 2021-03-11 | joint pain, muscular weakness, back pain |
Severe lower back pain across whole back about hand span width. Pain in right hip joint. Pain in lef...
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Severe lower back pain across whole back about hand span width. Pain in right hip joint. Pain in left upper leg with loss of strength in leg and could not lift leg up. The pain and discomfort in my back started to subside after 5-7 days. Today (day 10) the pain is gone from my hip. I still have weakness and discomfort in my left leg. Saw my M.D. today and will start physical therapy for the leg. Also first day not needing to take Tylenol which did not effect the pain at all for the first week.
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| 74 | 2021-03-14 | joint pain, joint swelling |
Began with left knee and lower leg pain and swelling on 3/2/2021 at approx. 1500. Could barely put ...
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Began with left knee and lower leg pain and swelling on 3/2/2021 at approx. 1500. Could barely put weight on left leg. Placed bag of ice under left knee/lower leg to decrease pain/swelling for 20 minutes. Removed ice and wrapped a heating pad around left knee and went to bed for approx. 11 hours. Awoke at 0230 and almost fell to floor because left leg and knee was very swollen and painful. Left arm was swollen from upper arm to wrist. Whole face also appeared swollen. Denied redness and hardness. Went back to bed and awoke at 0930 - took two Tylenol for left arm soreness where injection was. Swelling slowly subsided throughout the day and she stated that she felt so much better in am of 3/5/2021 (Friday).
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| 74 | 2021-03-14 | joint pain, muscle pain |
extreme joint pain; severe muscle pain; headache; chills; nausea; This is a spontaneous report from ...
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extreme joint pain; severe muscle pain; headache; chills; nausea; This is a spontaneous report from a non-contactable consumer. A 74-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) intramuscularly on 03Feb2021 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis; osteoarthritis; and allergies to medications, food, or other products; all from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included meloxicam from an unknown date for osteoarthritis, which the patient had discontinued 2-3 days prior to immunization. The patient received the vaccine on 03Feb2021, the following day, 04Feb2021, the patient felt like she "got hit by a truck;" she complained of extreme joint pain, severe muscle pain, headache, chills and nausea. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was provided for the events. The patient reported she gradually improved over the next 3-4 days and resolved. The clinical outcomes of extreme joint pain, severe muscle pain, headache, chills, and nausea were recovered in Feb2021. It was also reported the patient had not been tested for COVID-19 since vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 74 | 2021-03-14 | muscle pain | muscle soreness, fatigue |
| 74 | 2021-03-15 | joint pain | Chills, aches in joints, head, skin. Slight indigestion. |
| 74 | 2021-03-15 | muscle pain, joint pain |
left thigh became painful, it seems its the muscle on top of the thigh. Most painful at hip site and...
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left thigh became painful, it seems its the muscle on top of the thigh. Most painful at hip site and at out side of left knee, sometimes directly in middle.
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| 74 | 2021-03-16 | joint pain |
She got her vaccine and it was so high up that it hit a nerve in her joint. She did not have any sy...
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She got her vaccine and it was so high up that it hit a nerve in her joint. She did not have any symptoms after the injection. Went to bed, and woke up and her arm is swollen, it's like she has a frozen shoulder, is pounding pain, extremely tight, difficult to move, can't move it, and very constricted which prevents her from using it. The pain goes all the way down to her elbow. She cannot use the left hand, and when she tries to move her arm at the elbow has excruciating pain. She took 2 Tylenol which helped, but the pain comes back when it's time for more Tylenol and is also taking Ibuprofen but the symptoms are still there. Just to lift her arm up to put on the arms of a chair is painful with no mobility in the arm.
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| 74 | 2021-03-16 | flank pain | Developed pain in left side. Went to urgent care and diagnosed as shingles |
| 74 | 2021-03-16 | muscle pain, joint pain |
Intense muscle and joint pains -- I'm not sure that these are related to the vaccine. I note that th...
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Intense muscle and joint pains -- I'm not sure that these are related to the vaccine. I note that they have worsened with the second dose of the vaccine.
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| 74 | 2021-03-18 | joint pain |
Soreness in arms/shooting pains in her right arm that are shooting; Breasts are sensitive/Her breast...
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Soreness in arms/shooting pains in her right arm that are shooting; Breasts are sensitive/Her breasts are very sensitive and sore; Breasts are sensitive/Her breasts are very sensitive and sore; Swelling in her calves, her left and right arms; Swelling in her calves, her left and right arms/her hand was swollen, and her whole arm was like a log, it has been very uncomfortable; Her arm is very, very sore at the site of injection/Her right arm where vaccine was given her elbow is still swollen and sore below injection, and swelling where arm is connected to elbow.; Her joints in her elbows, wrists, and ankles are hurting/lot of joint pain; Nauseous; lymph nodes were affected and swelling; Tired; Swelling everywhere; Her right arm where vaccine was given her elbow is still swollen and sore below injection, and swelling where arm is connected to elbow.; uncomfortable; This is a spontaneous report from Social Media by a contactable consumer (patient). A female patient of 74-year-old received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via unspecified route of administration in right arm on 05Feb2021 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included chronic kidney disease from an unknown date in 2012. The concomitant medication was not reported. The patient stated that have not had any other recent vaccinations or started any new medications. The patient reported that on an unknown date Feb2021, soreness in arms, she has had swelling in her calves, her left and right arms. She said her arm is very, very sore at the site of injection, her breasts are very sensitive and sore, nauseous and later went away, had a lot of joint pain and swelling everywhere, her lymph nodes were affected and swelling, her right arm where vaccine was given her elbow was still swollen and sore below injection and also specified that swelling where arm is connected to elbow. It was also reported that hand was swollen, and her whole arm was like a log, it has been very uncomfortable on an unknown date in Feb2021. The patient has been tired on an unknown date in Feb2021 and patient worried about recovery of events. The patient stated that lymph nodes took 2-3 days, which started Sunday (as reported). It was reported that patient was still in sore, the breasts are super sensitive, which was weird. The patient also had strange shooting pains in her right arm that are shooting through it. The patient left arm was sore, but not as sore as her right. She said her knuckles were cracking when her hands move, and her right wrist was very sore but that was not so bad now. The patient stated that she thought these events were due to her good immune system. The joints were still sore, her elbows, all of the upper part of her body were also sore. The patient also reported that she was told older people don't have much reactions, but she certainly had. The patient had not seen doctor for the events. The patient took acetaminophen (LOT M045G, EXP Dec2023) as a treatment medication for the events. The outcome of the events nauseous was recovered on an unknown date in Feb2021, for the events swelling everywhere, uncomfortable, tired, lymph nodes were affected and swelling, breasts are sensitive/her breasts are very sensitive and sore was unknown while for rest of the events was not recovered
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| 74 | 2021-03-18 | joint pain |
autoimmune disorder; Sjogrens disease; tired; Headache; Joint pain; throat felt like it was closing;...
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autoimmune disorder; Sjogrens disease; tired; Headache; Joint pain; throat felt like it was closing; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: EL9261, Expiration Date: May2021) via an unspecified route of administration in the right arm on 06Feb2021 (at the age of 74-year-old) as 0.3ml, single for COVID-19 immunisation. The patient relevant medical history included Lichen planus from an unknown date in Nov2020 and ongoing (get sores on her tongues and inside of her cheek and monitored by dentist every six months). The concomitant medication was not reported. On 06Feb2021, (Saturday) the patient experienced tired, headache, joint pain, states she also felt like her throat was closing. It was reported that she has been tested for sjogrens disease and the doctor stated she may have an autoimmune disorder on an unknown date. States her symptoms started several hours after the vaccine on the same day, states when she woke up the next morning, she felt fine. The patient stated that she had epi pen, wondered if when her throat felt like it was closing should she have used that. The outcome of the events autoimmune disorder, sjogrens disease was unknown while for other events tired, headache joint pain and throat felt like it was closing was recovered on 07Feb2021.
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| 74 | 2021-03-18 | muscle pain, joint pain |
Sore injection site; joint aches; Chills; headache; nausea; vomiting; muscle pain; listless; fever; ...
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Sore injection site; joint aches; Chills; headache; nausea; vomiting; muscle pain; listless; fever; no appetite; Not feeling well; still tired; sleeping a lot; Very fearful of taking the second shot; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 (Lot Number: EM0910) as single dose for covid-19 immunization. Medical history included mild chronic obstructive pulmonary disease, asthma, bronchitis, sinus infection and sulfa allergy from unknown dates. The patient previously took and experienced allergies to acetaminophen, montelukast sodium, hydroxyzine, budesonide-formoterol fumarate and pseudoephedrine hcl. On 09Feb2021, at 01:00, the patient experienced sore injection site with outcome of unknown; joint aches with outcome of unknown; chills with outcome of unknown; headache with outcome of unknown; nausea with outcome of unknown; vomiting with outcome of unknown; muscle pain with outcome of unknown; listless with outcome of not recovered; fever with outcome of unknown; no appetite with outcome of unknown; not feeling well with outcome of unknown; still tired with outcome of not recovered; sleeping a lot with outcome of not recovered; very fearful of taking the second shot with outcome of not recovered. No treatments were given for the events. Details were as follows: the adverse events included sore injection site, joint aches, chills, headache, nausea, vomiting, muscle pain, listless, fever, no appetite, not feeling well, all in that order. Worst side effects were gone by the third day; she was still tired, sleeping a lot and was listless. The patient was also very fearful of taking the second shot. The events resulted in doctor or other healthcare professional office or clinic visit on an unspecified date.
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| 74 | 2021-03-18 | muscle pain |
she slept and slept and slept; bad headache; very tired; muscle aches and pains; where she had gotte...
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she slept and slept and slept; bad headache; very tired; muscle aches and pains; where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that; where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249, Expiration date: May2021), via an unspecified route of administration in left arm 03Feb2021, at 10:50 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient medical history included Prediabetes (5 years ago) and obviously overweight and had cat bite. The concomitant medication was not reported. The patient previously took historical vaccine, on an unknown date in Jan2021 (she got the first dose three weeks before on a Wednesday), first dose of bnt162b2 for COVID-19 immunisation and had no reaction. On 03Feb2021 (early evening) the patient experienced a bad headache and was very tired. Caller says where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that. She says she also had muscle aches and pains. The patient took Aspirin (UPC 9629513147, LOT: P115130, EXP: May 2021) for the event muscle aches and pains at a dose of 325mg, one before bed, took three during night total. The patient reported that she slept and slept and slept on an unknown date in Feb2021. It was reported that patient lots of bloodwork done over the years but if she eats correctly it goes away, then if she gets into the sugar, it comes back. The outcome of the events, where she had gotten a cat bite in her hand, where the bite was, was very sore which it wasn't before that and she also slept and slept and slept was unknown while for other events was recovered on an unknown date in Feb2021.
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| 74 | 2021-03-18 | neck pain, joint pain |
Joint ache, head and neck ache, skin ache, chills, slight fever. Started night of second shot, Mon...
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Joint ache, head and neck ache, skin ache, chills, slight fever. Started night of second shot, Monday, stopped about 24 hours laterTuesday. Started again third night, Wednesday, stopped next morning. Started again Thursday night and is continuing on Friday (today). Secondary starts are not as strong as first night but are still very uncomfortable and do not allow for a good night?s sleep. Have been taking aspirin and Advil.
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| 74 | 2021-03-20 | back pain | Bad headache, back ache, chills. shot arm hurt |
| 74 | 2021-03-22 | back pain |
Caller is pt's wife, all information was obtained from caller. 74 year old male received 1st dose of...
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Caller is pt's wife, all information was obtained from caller. 74 year old male received 1st dose of Pfizer COVID-19 Vaccine Lot# EL8982 at location on 01/25/2021 @ 10:30. On 01/28/2021 pt started feeling chills, which resolved in 2-3 weeks. Pt started feeling back pain around 02/15/2021, went to Clinic around 02/17/2021 for the pain. The 2nd dose of Pfizer vaccine was due on 02/17/2021, pt had to cancel 2nd dose appointment due to Clinic appointment. Clinic staff told pt back pain was most likely due to a pinched nerve or lower back problems that comes with age. No x-rays or blood work was performed at Clinic. On 02/21/2021 pt stood up and felt even worse lower back pain, couldn't walk, pt went to ER and was admitted for 5 days, discharged 02/26/2021. Blood work was done and showed hyperkalemia, proteinuria, and kidney failure, upon discharge ER staff told pt to follow up with nephrologist. Nephrologist appointment is scheduled for 04/01/2021. Pt takes Morphine sulfate IR 15mg, Atenolol 50 mg, Fenosteride 5 mg, and Terazosin 10 mg. Pt has Myeloma, Hypertension, and Benign Prostatic Hyperplasia. Caller denies pt has any allergies. Pt will receive oncology treatment 03/29/2021, the oncologist alerted the caller the 2nd dose must be administered to the pt before oncologic treatment. Caller asked if the pt should get the second dose due to the kidney failure occurring after the 1st dose was administered. Currently pt is only experiencing lower back pain. Pt was advised that it is unlikely the vaccine caused kidney failure and the pt should get the second dose as soon as possible. SPI was consulted and Dr. was notified.
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| 74 | 2021-03-22 | neck pain, joint pain | Patient reports shoulder pain that radiates up neck. |
| 74 | 2021-03-23 | back pain |
SEVERE, SEVERE back pain, from lower to upper back. trouble breathing--taking a deep breath. using ...
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SEVERE, SEVERE back pain, from lower to upper back. trouble breathing--taking a deep breath. using Tylenol for pain, but it is barely making a dent in the pain. started Sat. morning, bad on Sun. (3/21); then Mon. and Tues. morning = not so bad. but Tues. night and today, Weds. 3/24, VERY BAD pain in back returned, rendering me dysfunctional.
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| 74 | 2021-03-24 | joint pain |
First day, excruciating pain over my entire body, could hardly get out of bed, chills, hot flashes, ...
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First day, excruciating pain over my entire body, could hardly get out of bed, chills, hot flashes, nausea, extreme tiredness that sleep did not help. Also, hot flashes during night. took Tylenol. Second day, pains were mostly gone, but nausea and a sore arm where the injection was given, and dizziness, and tiredness. But if I would lie down, I couldn't sleep. Later that day my injection site was swollen, redness (about size of an orange) sore to the touch and itched, and was hard. The third day my injection sites pain went further to my left breast, up to my shoulder. It had spread and was now a light pink. A small amount of dizziness.
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| 74 | 2021-03-24 | muscle pain |
Injection site is red, swollen, warm to touch, and sore. More muscle soreness than previous days si...
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Injection site is red, swollen, warm to touch, and sore. More muscle soreness than previous days since injection three days ago.
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| 74 | 2021-03-25 | spinal pain, joint pain |
Malignant hypertension Blood Pressure up to 220/108 within 12 hours after first dose vaccine Chest ...
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Malignant hypertension Blood Pressure up to 220/108 within 12 hours after first dose vaccine Chest pain, SOB, headache and dizziness, ankles and wrists aches.. sever spinal pain. Debilitating pain and weakness
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| 74 | 2021-03-28 | muscle pain |
Patient reports prolonged fever, headache, body aches, muscle aches, fatigue. Still continuing 5 day...
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Patient reports prolonged fever, headache, body aches, muscle aches, fatigue. Still continuing 5 days after injection of 2nd dose. Patient also describes a pruritic rash to left arm (injected arm) that is described as having some small bumps and red blotches the size of quarter. Patient experienced no side effects from 1st dose.
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| 74 | 2021-03-30 | joint pain |
Wants to know if Prednisone will interfere with the effectiveness of COVID-19 Vaccine; recurrent pai...
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Wants to know if Prednisone will interfere with the effectiveness of COVID-19 Vaccine; recurrent pain in the left hip; Inflammation; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 10Feb2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Nurse. This 74-year-old female Nurse (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown), reason for no lot number of COVID-19 Vaccine; other; was not provided lot number or patient card, NDC number, expiry date; unknown via an unspecified route of administration from 10Feb2021 at 11:00 am to 10Feb2021 at 11:00 am at single dose (dose number; 1) for covid-19 immunization. Is COVID-19 Vaccine a Pfizer product; Yes, COVID-19 Vaccine manufacturer; Unspecified. Patient was 74 years old at time of vaccination with weight; 115.67 kg, height; 157 cm. Patient's medical history included back problems and had a spinal fusion in the past. Back problems occurred prior to COVID-19 Vaccine (dates unspecified). Patient's concomitant medication included prednisone, batch/lot number: unknown, reason for no lot number of prednisone; product dispensed in pharmacy vial, NDC number; 59746-0172-06, expiry date; unknown, Is Prednisone a Pfizer product; unspecified, Prednisone manufacturer; unspecified via an unspecified route of administration from an unspecified date to an unspecified date at 5 mg; decreasing dose; 60 pills over 15 days for back problems. Other products were reported as no. Consumer wanted to know the impact of prednisone on the Pfizer COVID-19 vaccine. Potential AE. She got COVID-19 vaccine inoculation this morning around 11:00 am. She had just come from the doctor regarding back problems. Doctor wants her to start on Prednisone. She thinks maybe it is not the best idea. She wants to know if Prednisone will interfere with the effectiveness of COVID-19 Vaccine. She has not started taking the Prednisone yet. She will do without Prednisone if it is going to affect the COVID-19 Vaccine. HCP details were not provided. She has no NDC/Lot/Exp for her COVID-19 Vaccine. She was told she will get a patient card after her second dose. Indication: the age group she is in. Unable to locate Lot/Exp on Prednisone. Stated it is in a pharmacy bottle. Back Problems: She had a spinal fusion in the past. Now having recurrent pain in the left hip. Doctor is assuming there is a nerve pinched high up and wants to reduce the inflammation. The outcome of events was unknown. Information about Lot/Batch number is requested.
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| 74 | 2021-03-30 | musculoskeletal chest pain |
Started with rapid heart beats; Lungs sore; Headache; sore all around; Chest wall was painful; Weakn...
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Started with rapid heart beats; Lungs sore; Headache; sore all around; Chest wall was painful; Weakness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right arm on 22Feb2021 05:00 (Lot Number: EN6203) at single dose for COVID-19 immunisation. Medical history included rapid heart beats control by medication, anxiety. Concomitant medications included metoprolol; alprazolam; and other vaccine (lot number: EL8982) received on 22Feb2021 in arm. The patient previously took codeine and experienced allergies; received bnt162b2 on 26Jan2021 (lot number: EN6203) in arm for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Started with rapid heart beats, lungs sore, headache, sore all around. Chest wall was painful. Weakness. Most of all systems went away, after the week of March12. Except the bad headache. They were still present. Events all started from 22Feb2021 05:00, resulted in Emergency room/department or urgent care. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Events were considered non-serious per reporter.
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| 74 | 2021-03-31 | bone pain, muscle pain |
doesn't feel that well; It hurt there at where the needle went in, in the beginning; something is ha...
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doesn't feel that well; It hurt there at where the needle went in, in the beginning; something is happening to her arm but it is not where the needle went in/it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone; something is happening to her arm but it is not where the needle went in/it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone; something is happening to her arm but it is not where the needle went in/it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone; something is happening to her arm but it is not where the needle went in/it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6205), via an unspecified route of administration, administered in the left arm on 03Mar2021 (at the age of 74 years old) at a single dose for COVID-19 immunization. Medical history included lumbar spine infusion (operations on spinal cord) from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that the patient needed the call handler to speak slowly, she doesn't feel that well. She had the first dose of BNT162B2 last 03Mar2021 and the second dose will be on 23Mar2021. She said something was happening to her arm but it was not where the needle went in, that is not where it is. It hurt there at where the needle went in, in the beginning but now it hurts down toward the elbow and it penetrates through the epidermis, endodermis and the muscle and feels like it's at the bone. She hopes it was not a blood clot. She has been looking at the website and they say people could have blood clots and she does not know if this was a blood clot, she can't hardly lift her arm, it was the left side that the shot was in because her right side is partially paralyzed due to effect of lumbar spine infusion and so when she tried to get up sometimes she can hardly lift that arm and so she didn't know what to do if she should call the primary care doctor to see if she has a clot but she read it and it says to call this number if you are having compactions and she been on hold over and hour and a half. It was hurting and the feeling like she couldn't hardly raise the arm or get any kind of strength in it. She knew in Europe they have had few people who have had blood clots, and she thought could that be a sign of a blood, like blood not moving through her veins like it is supposed to. It is not moving it has not made it to her heart yet. She says it is associated with the product, this is the only thing she has had in her arm she knows it is the product. She said her birthday just passed. She turned 75 years old but when the issue started in her arm she was 74 years old. It did not start the first week, the first week it was just sore around where the shot went in but then last week it started happening where it was hurting down her arm and she was getting close to the second shot which she doubts she will have but it is the 23rd which is next week. She used to be 5'2" but the operations on her spinal cord, she guesses she might be 4''10 now. She does not know because she can't hold her head up straight because the doctor that fused it, she indented it instead of it being more out and because of that her head is forward and down. It was also reported that she hasn't been to the doctor she only goes to pain management for him to check out her body and everything and renew prescriptions. The outcome of the events was unknown.
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| 74 | 2021-03-31 | musculoskeletal stiffness |
it takes her a while to get the body parts moving; She does not feel like eating; headache; her stom...
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it takes her a while to get the body parts moving; She does not feel like eating; headache; her stomach is pretty upset; her neck is kind of stiff/Aches were Neck/back of head is kind of stiff; pain around the arm/her arm was hurt/upper left arm to bottom of arm was sore; This is a spontaneous report from a contactable consumer (patient) reported that: A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on Friday, 12Mar2021 in the early morning probably about 08:30 AM as single dose for covid-19 immunisation. She was 5'4, but thinks she shrunk a little bit and is now 5 feet 3 inch. Initially stated no medical history, but then reported she gets migraines. Caller reported she does not get them on a regular basis; had more in her younger years, migraines are hormone driven and once she went through menopause, she stopped having them regular; she maybe gets them 5 or 6 times a year now. The patient's concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer Suspect. The patient really did not have a reaction on the day of the vaccine, no swelling or soreness. The next day, Saturday, 13Mar2021, and Sunday, 14Mar2021, she noticed her arm was hurt, she wants to know if that could be a reaction. The patient stated that, at the time, she just dismissed it. It stopped hurting on Sunday. Today, 16Mar2021, on Day 4, she woke up with a headache and her stomach is pretty upset. She heard people say right after they got the shot that they had side effects, the same thing she is having, so she doesn't know if this is random and doesn't know if it's connected to the vaccine or not. She is concerned and wants to know if she should get the next dose of the vaccine. Clarified the pain was not at the injection site; her upper arm and maybe to her elbow was just sore, no swelling or redness, just sore arm. This lasted through the next couple of days after the shot. Patient mentioned that she absolutely did not have much of a reaction; she has had issues with bee stings in the past, described as big, huge swelling and redness, no breathing associated with it. Patient stated she has been told that is a reaction. She clarified she did not have anything like that on the day of the injection itself. She is in between doctors right now; she doesn't have PCP. She hears from friends that the PCPs do a lot of diagnosing and treatment over the phone. She doesn't know if it's a state thing because she's been to dermatologist, eye doctor, had her teeth cleaned twice at the dentist during this pandemic. It feels like maybe she has some aches; her neck is kind of stiff, maybe because she has been in bed all day, because of her age, she can feel aches and pains more often. Patient also mentioned that in the morning, it takes her a while to get the body parts moving. She has not been up and has been in bed. She is laying back down again because her neck or back of her head felt kind of stiff. No treatment was taken. She did not take or eat anything today yet because her stomach has been upset. It has been 4 days since she received the vaccine, and she would assume she would've gotten the side effects closer to the day of injection. She is scheduled for the second dose on 29Mar2021, and she has questions about that: if this means anything, is this connected to the injection. Headache started at about 6 AM when she woke up this morning. She has been holding off on taking Aleve or Excedrin because of the upset stomach waiting for that to calm down because she does not want to throw up. She does not feel like eating. She has not eaten yet, but she knows she needs to. She doesn't know if it's her neck or the back of her head, but it is kind of painful when she stands up. Her stomach might feel a little better, not that she's hungry, but she's thinking more that she needs to eat whereas this morning she was not going to do it and didn't care. She has basically been in bed all day; she spent more than an hour on hold. Clarified that she was not sleeping, but in bed. When she got up, she noticed pain in her neck or back of head. She had not been up long enough to tell if it's still going on, she just got up once or twice for a quick bathroom break. She does not know when the pain started, she could've had the pain before, but she just noticed it. Patient mentioned that while she is laying down, it doesn't hurt. Aches were Neck/back of head is kind of stiff; kind of painful when she stands up exact time unknown but hurts when she gets up. She had nothing on the day of; she was bragging to everyone it didn't hurt. Caller clarified the upper left arm to bottom of arm was sore. She asked one of her friends if she had a sore arm after the shot and she said no. No additional information provided. she just went back to bed and figured she'd sleep it off. Relevant Tests: Antibody in Early Feb2021 and Covid test- She does not know the exact date of the Covid Test, but she would guess 16Feb2021 or 17Feb2021. She thinks it was the rapid test: Both were negative. Outcome of the events were upper left arm to bottom of arm was recovered on 14Mar2021. Headache was not recovered; stomach is pretty upset was not recovered. Aches- Neck/back of head is kind of stiff; kind of painful when she stands up, it takes her a while to get the body parts moving, She does not feel like eating,her arm was hurt, upper left arm to bottom of arm was sore were unknown. Information on the lot/batch number has been requested.
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| 74 | 2021-03-31 | muscle pain | Chills, fever (101.3), overall fatique and muscle soreness. Onset 14-16 hours after injection |
| 74 | 2021-04-01 | back pain |
weak; lightheaded; My blood pressure low 80's to 90's over 40's to 50's all thru night; dehydrated p...
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weak; lightheaded; My blood pressure low 80's to 90's over 40's to 50's all thru night; dehydrated prior to this admit; shaking; chills; severe headache; right mid and low back pain; high fever up to 103 degrees; Not able to get out of bed except to get to nearby bathroom; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 74-years-old via an unspecified route of administration, administered in arm left on 05Mar2021 15:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation. Medical history included anal cancer (h/o anal cancers/p chemo & RT2013), hypertension, hypothyroidism and new fe deficiency anemia dx during this admit from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient has known allergies to Ampicillin, clindamycin, trilafon, imipramine. The patient reported that 4.5 days after 1st dose of Pfizer vaccine on morning of 10Mar2021 09:00, the patient woke up with shaking chills, severe headache, right mid and low back pain, high fever up to 103 degrees within 1/2 hr of onset and not able to get out of bed except to get to nearby bathroom to use toilet when needed. The patient took Tylenol 500 mg up to 5 doses by 10:00 am of 11Mar2021 when fever would not abate; the patient was weak and lightheaded on an unspecified date and since lived alone called a number to take her to ER. On an unspecified date, her blood pressure was low 80's to 90's over 40's to 50's all thru night and 1000 more mg of Tylenol was given at 4:00 am and fever then lowered to 99 or 100. Full infectious work up negative for bacterial sources including abdominal and pelvic cat scan, abdominal ultrasound, CXR, urine culture, she received 2 1/2 liters of IV fluid and IV Ceftriaxone and Flagyl in ER. In case bacterial cause which was not found including blood cultures, due to her BP still not improved by 5:00 am as she was dehydrated prior to this admit, she was admitted on medicine floor for 2 days. The patient underwent lab tests and procedures which included abdomen scan: unknown result on an unspecified date, blood pressure measurement: low 80's to 90's over 40's to 50's all thru night on an unspecified date; still not improved on an unspecified date, body temperature: high fever up to 103 degrees on 10Mar2021; 99 or 100 on an unspecified date, chest x-ray: unknown result on an unspecified date, culture urine: unknown result on an unspecified date, sars-cov-2 test: negative on 10Mar2021, ultrasound abdomen: unknown result on an unspecified date. Therapeutic measures were taken as a result of the events which included IV, fluids, 1 dose of 2 different IV antibiotics (Ceftriaxone and Flagyl) and Tylenol. The patient was recovering from the events.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 74 | 2021-04-01 | muscle pain |
Severe: fatigue headache diarrhea muscle pain joint pain chills nausea lasting 48 hours Had problems...
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Severe: fatigue headache diarrhea muscle pain joint pain chills nausea lasting 48 hours Had problems staying hydrated due to nausea
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| 74 | 2021-04-03 | joint pain |
joint pain all over her body that was real bad/her arms, she could not raise her arms/her feet hurt,...
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joint pain all over her body that was real bad/her arms, she could not raise her arms/her feet hurt, everything, all her joints in her body hurt; one lymph node is swollen; It's been misery; feels tired; her knees started hurting real bad; she couldn't make a fist, she couldn't do anything with her fingers.; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EL9265, Expiration Date: unknown), via an unspecified route of administration, on 03-FEB-2021 at single dose for Covid-19 immunization. The patient medical history included Arthritis, allergic to ACE. Concomitant medication was not reported. She went 03Feb to get her first shot, her first COVID shot and she thinks it started Monday. She had arthritis in her knees and her knees started hurting real bad but she didn't think much of it then all of a sudden, everything started going, her arms, she could not raise her arms she couldn't make a fist. She couldn't do anything with her fingers. Her lymph node swelled and it made her throat hurt and her feet hurt, everything, all her joints in her body hurt. That was when she knew it wasn't arthritis when it was her shoulders and arms she knew she does not have arthritis there and it took her a while to figure it out. She felt bad and her husband was concerned about her and she told him maybe its the COVID shot and he didn't think it would be that, he thought it was just her arthritis and she got her paper out from the first shot and it listed joint pain, she had the joint pain, tiredness, and swollen gland. later it was relaxed a little. It was a whole week for her, she has a hard enough time with regular arthritis. It almost froze her, it almost made her feel frozen. She was up all night she couldn't sleep, she was miserable she was up and down, up and down. She was cat napping, she would fall asleep and then it would wake her up. They haven't changed any meds and she didn't have any problem. Nothing was new it was not any medications that she has taken. She confirms that her lymph node in her neck was swollen and it made her throat hurt when she swallows, that was gone down now. It was starting to go away it is not all the way gone but she can live with it now. The outcome of event was recovering. Description of complaint: The patient reported her experience after the Pfizer COVID 19 vaccine. She reported that she had join pain all over. She says her doctor's office was closed because the doctor was under quarantine. She definitely would've gone to see him to beg him to give her something for pain because Aspirin was not doing it. No further information provided. Product strength and count size dispensed was not provided.
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| 74 | 2021-04-03 | muscle pain |
Length: 2-1/2 days Symptoms: Severe headache, muscle ache, vomiting (once), chills, slight fever ...
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Length: 2-1/2 days Symptoms: Severe headache, muscle ache, vomiting (once), chills, slight fever of 99.9 (checked only once), tiredness, and what I call Devils grip (pain from right to left under breasts, unable to breath deeply, lasted approximately 1/2 hour.
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| 74 | 2021-04-07 | back pain |
Patient presented to ER with R back pain paresthesia. CTA performed:Segmental and subsegmental pulm...
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Patient presented to ER with R back pain paresthesia. CTA performed:Segmental and subsegmental pulmonary emboli involving the left upper lobe.
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| 74 | 2021-04-09 | bone pain |
February 17, 2021: Patient received 1st dose of PfizerBioNTech vaccine. Reported mild cough, nause...
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February 17, 2021: Patient received 1st dose of PfizerBioNTech vaccine. Reported mild cough, nausea and bone pain lasting one week. However, she felt it wasn't severe enough to contact me as her asthma specialist. No cough per patient for the week prior to the second dose of PfizerBioNTech. March 10, 2021: Patient received 2nd dose of PfizerBioNTech vaccine at 1:10pm. Said she had mild chest tightness during the waiting period and used her Ventolin but she attributed it to the characteristics of the waiting room area. Between 5:00pm and 6:00pm (~4 hours later), she became light-headed, vomited and began to cough frequently. She contacted her primary care physician who told her to use Mucinex and contact me if needed. March 12, 2021: Patient contacted my office in the early afternoon. Unable to stop coughing while on telephone. Came to office approximately 90 minutes later. Physical Exam; Peak Flow 210 (personal best 310-320), oxygen saturation 93-95% (typically 97-98%), temp-98.2 F. Intractable cough with scattered bilateral expiratory wheezes on auscultation. Heart rate 132 and regular. Patient treated with Levalbuterol 1.25 mg nebulization with subsequent modest improvement in frequency of cough, pulse 102, oxygen saturation 96-97%. She declined going to emergency department of hospital because she did not want to get infected with COVID-19 from a patient in the waiting room. She declined Prednisone when told that the corticosteroid might reduce the efficacy of the 2nd dose of the vaccine. Placed on Budesonide 1 mg bid and Levalbuterol 1.25 mg q4-6h prn. March 16th: Patient reported her cough was 70% improved and wanted to stop Budesonide. Patient was told to continue Budesonide daily at 1 mg q day. April 5th: Patient contacted my office because of continued coughing and wheezing. Had been hospitalized March 25-27 for the cough.
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| 74 | 2021-04-09 | limb discomfort |
elevated CPK; Unable to raise arm; arm became sore; Muscle trauma/ some kind of damage either to hea...
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elevated CPK; Unable to raise arm; arm became sore; Muscle trauma/ some kind of damage either to heart muscles to the brain or some skeletal muscle on the body; Muscle trauma/ some kind of damage either to heart muscles to the brain or some skeletal muscle on the body; This is a spontaneous report from a contactable nurse reported for herself. A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EP7534, expiration date: 31Jul2021, via an unspecified route of administration, administered in left deltoid (also reported as left arm) on 21Mar2021 at a single dose for COVID-19 immunisation; and rosuvastatin calcium, oral from an unspecified date (Lot Number: 20082811; Expiration Date: Jul2022) to an unspecified date, at 5mg every night for hyperlipidemia and Stage 3 kidney disease. Medical history included hypertension (diagnosed maybe 30 years ago, it is controlled), status ventricular tachycardia in 2001 (controlled), stroke (suffer stroke may be 12 or 13 years ago without the residual), Phase 3 renal disease/Stage 3 Kidney Disease, extracted tooth, bad tooth, aches and pain in her legs in Jan2020 and ongoing, and muscle pain. Patient did suffer stroke may be 12 or 13 years ago without the residual, it was incidental finding with the MRI with the brain because she had a bad tooth and they extracted the tooth, they decided to complain let's do a brain MRI of the brain and it showed an influx in right cerebellum but without residual she have no deficit, but they put her on Plavix first but the bruising was very severe so they changed it to Aggrenox which she successfully use Aggrenox now. Other medical conditions: Consumer stated, Folic acid, sodium bicarbonate, yes the Soda Bicarb (sodium bicarbonate) is for the Phase 3 renal disease but numbers are good, my DE creatinine all was normal but my nephrologist who happened to be a friend of mine said stage 3 renal disease. Concomitant medications included acetylsalicylic acid, dipyridamole (AGGRENOX) taken for antiplatelet therapy, and paracetamol (TYLENOL) taken for pain. Concomitant medication: Consumer stated, "I take lots of medication, I mean I take Tylenol but none these have a direct correlation to the, I take Aggrenox, Aggrenox is antiplatelet, oh you are a pharmacist so you know that, that's Persantin and aspirin that's the combo, its antiplatelet." Patient has no additional vaccines administered on same date of the Pfizer suspect. Patient previously took clopidogrel bisulfate (PLAVIX) and experienced bruising; folic acid, and Soda Bicarb (sodium bicarbonate) for phase 3 renal disease. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EN6203, expiry date: 30Jun2021, on 28Feb2021 for COVID-19 immunization. It was given in her left arm. She received the second dose of the Covid-19 vaccine on Sunday (21Mar2021). Her arm became sore on 21Mar2021. On Wednesday (24Mar2021), she was unable to raise her arm even in the shower. She saw her doctor on Thursday because she is on a statin and had aches and pain in her legs. They drew blood and found that she has an elevated CPK on 26Mar2021. It is not grossly but is elevated and has had muscle trauma. Could there be a connection? She reduced the statin to three times a week. The arm soreness is 30-40% improved. She can move her arm away from her body. It felt like she hit her elbow in the funny bone. It was an odd feeling down to her fingertips. The vaccine card indicates the vaccine was given in her right deltoid but it was given in her left deltoid (Left arm). She clarified that she is taking Rosuvastatin Calcium instead of Crestor. She added that she has Stage 3 Kidney Disease. The Nephrologist had told her that she needed to take Rosuvastatin Calcium 7 days a week instead of three. She has only had the pain since she started taking it daily. She stopped taking it daily this past Monday night. She told her doctor she will be taking it only on Monday, Wednesday and Friday. Consumer further stated, she had a very sore arm that she cannot lift over her hand, it feels like somebody hit her elbow. Consumer further reported and stated that she had the Pfizer second vaccine on Sunday (21Mar2021), by Wednesday (24Mar2021), she could not lift her arm, she went to her doctor yesterday and she was a nurse for 54 years so she did not think that was big deal, vaccine do give you a sore arm. However, she drew blood, well she didn't, the technician drew blood in that arm and her CPK is elevated, Patient stated "am I speaking to a pharmacist, doctor or, okay CPK indicated some kind of damage either to heart muscles to the brain or some skeletal muscle on the body. Mine has never been elevated, it's not growth fully elevated like indicative of cardiac event, However, it is elevated so I thought I should report this to Pfizer so I want you to know that, this is unusual finding." She was on a statin drug, she was on Crestor 5 mg once a day (clarified that she is taking Rosuvastatin Calcium instead of Crestor), however she cut it back to just 3 times a week now because her cholesterol numbers are good, my LDL and HDL are all good and the Cholesterol drug (Intent: Crestor) is known to cause this muscle aches and pain but this is so coincidental with this arm, her left arm where she received vaccine and this CPK being elevated and she thought perhaps Pfizer should be made aware. Consumer stated, "I have been a nurse, I am retired now, I am 76 but I had been a nurse for 54 years, I was at one time director of nursing, so I am familiar with the healthcare system and most medications but of course this Pfizer vaccine and Moderna and Johnson and Johnson these are brand new, this is a Covid pandemic so. Causality: Consumer stated, I kind of think there is connection there sir, because remember that it could be, muscle damage that elevates your CPK, it could be cardiac muscle, it could be a stroke, neither which I didn't have a heart attack. I was having a lot of muscle pain, prior because of the Crestor but that is the common side effect of any statin drug can cause muscle aches and pains. However, I thought there was quite a connection getting the vaccine in the right arm, not being able to raise my (incomplete sentence) now vaccine was Sunday which was I believe the 21st and this event did not happen until, I was sore Sunday evening but the unable to raise it was Wednesday, which was 3 days later yeah and the blood draw was yesterday morning and this morning my doctor called me to tell me that my CPK was elevated not grossly but enough to make the phone call. Consumer stated, the first one was on 28Feb2021 and the lot number was EN620, I need my magnify glass, there is one right here because it's so small, okay its EN62C or is it 0, it's hard to tell 3 is the last number. The second dose with lot number is EP7534. Consumer stated, Let me just look at the calendar to make sure that was Wednesday, I got the shot on 21st, yes sir, it was the 24th, the arm was sore even that evening the 21st (21Mar2021), evening of the 21st but the inability to move it was Wednesday the 24th, I could not move even move it away from my body so I was guarding it, today it's not as bad, I can move it but I still feel it like up in my shoulder. When confirmed if the event has improved, consumer stated, I would say yes but not totally gone. Consumer stated, I just took Tylenol that's all, I mean what I was going to do, I think I took, I know I took a shower last night Wednesday at night, I might let the warm water run on it, I might have, I don't remember, I took a shower regardless so." Lab test: Consumer stated, "I had blood work yesterday all my values were normal, Cholesterol was normal the only thing that was elevated was the CPK." Consumer stated, "I thought that it was necessary to report it okay, is there any way you can tell me is this a common occurrence where CPK elevates slightly." The action taken in response to the events for BNT162B2 was not applicable and for rosuvastatin calcium was dose reduced. The outcome of the events 'arm became sore, unable to raise arm, elevated CPK and muscle trauma (muscle injury)' was recovering while the outcome of the other event was unknown. The reporter considered the events 'arm soreness, unable to raise arm and elevated CPK' as serious (medically significant). The causality of the events 'arm soreness and unable to raise arm' was related to BNT162B2, and event 'elevated CPK' was related to rosuvastatin calcium.; Sender's Comments: Based on a drug event temporal association, the company cannot completely rule out a reasonable possibility that BNT162B2 caused the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 74 | 2021-04-15 | muscle pain |
Strong Fatigue. Chills in fingers and toes, headache in back of neck, muscle pain in arms and should...
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Strong Fatigue. Chills in fingers and toes, headache in back of neck, muscle pain in arms and shoulder, soreness at injection site, slight vision impairment lasting 24 hours
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| 74 | 2021-04-24 | limb discomfort |
Headache like my head was going to explode/severe headache like migraine/Pain level 10/10; headache ...
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Headache like my head was going to explode/severe headache like migraine/Pain level 10/10; headache like migraine/chronic migraine; symptoms of a stroke; weakness on my right side from tongue to nose; weakness on my right side from tongue to nose; extreme nausea; general malaise; My shot arm feel like felt like I had been hit for several days; This is a spontaneous report from a contactable consumer (the patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318) via an unspecified route of administration on 09Feb2021 at age of 74-year-old at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) on 19Jan2021 at age of 74-year-old for COVID-19 Immunization, the patient had no soreness or reaction until 10days later on 29Jan2021 when she had a low fever ~0.5-1 degree with chills and aches like a fever for 3 days, the patient experienced aches and pain; hurting all over on 29Jan2021, the patient took no medications, there were no further reaction. The second shot given on 09Feb2021, the patient's shot arm felt like she had been hit for several days beginning 10Feb2021. On 11Feb2021, the patient got a severe headache like migraine. Pain level 10/10. She had chronic migraine with all symptoms of a stroke (extreme nausea and weakness on her right side from tongue to nose, extreme headache about left side of the head). The headache on 11Feb2021 was overlap headache. On both sides of head and nausea. No other migraine symptoms. It lasted for 3 days. The patient was hospitalized due to the event(s) headache like my head was going to explode/severe headache like migraine/ chronic migraine. The patient took only butalbital, caffeine, paracetamol (FIORICET, 50, 325-40) from 11Feb2021 to 12Feb2021 at 40mg caff for several headache like migraine; promethazine (PHENERGAN) from 11Feb2021 to 12Feb2021 at 25mg for several nausea. The patient had several events general malaise where she didnot feel like doing her thing until today 30Mar2021. She had taken no medications or seen a doctor about it. The outcome of "headache like my head was going to explode/severe headache like migraine/pain level 10/10", "headache like migraine/chronic migraine" was recovered in 2021. The outcome of other events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021145090 same patient, same drug, different event, different dose separated in times
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| 74 | 2021-04-26 | back pain |
troponin: high troponin levels; pain on the back of her head and her back; pain on the back of her h...
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troponin: high troponin levels; pain on the back of her head and her back; pain on the back of her head and her back; Chills; fever; She was shaking badly; Fainted; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 24Mar2021 11:15 (Lot Number: ER8727; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 74 years). Medical history included ongoing rheumatoid arthritis, melanoma, depression, heart attack (had a heart attack 7 or 8 years ago) and covid (covid in the first week of January). Concomitant medications included levothyroxine sodium (SYNTHROID) and escitalopram oxalate (LEXAPRO) for depression. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Mar2021 for covid-19 immunisation and experienced rash with itching and a lump and swelling (74 years). The patient fainted on 24Mar2021, chills and fever on 24Mar2021 20:00, pain on the back of her head and her back and a couple of places like anyone would get when they fall on 25Mar2021 and she was shaking badly on 24Mar2021. The patient underwent lab tests and procedures which included blood work: unknown results and troponin: high troponin levels on an unspecified date. Therapeutic measures were taken as a result of tremor included Aleve. Outcome of the events chills and pyrexia was recovered on 25Mar2021 (four hours) while outcome of the events head pain and back pain was recovering. Outcome of the remaining events was unknown.
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| 74 | 2021-04-27 | muscle pain |
Aching legs; Gradually getting worse; Her memory is affected; Muscle aches and pains; Felt out of so...
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Aching legs; Gradually getting worse; Her memory is affected; Muscle aches and pains; Felt out of sorts; Arm was sore; This is a spontaneous report from a contactable other hcp (nurse). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 18Jan2021 at 09:00 (Lot Number: EL3247, Expiration Date: Apr2021) as single dose for COVID-19 immunization. The patient's medical history included spinal fusion surgery from 2019 to an unknown date. The patient previously received 1st Shingrix injection and experienced her arm turned really red and swelled up (so her doctor told her not to take the 2nd injection). There were no concomitant medications. On 19Jan2021, the patient experienced arm was sore. On 21Jan2021, the patient felt out of sorts. On 22Jan2021, the patient experienced muscle aches and pains. She is not sure if the muscle aches are due to her just getting old or from the vaccine. The muscle aches are especially in her legs. On an unspecified date, the patient experienced aching legs, gradually getting worse and her memory is affected. She is gradually getting worse, but doesn't know if it's the weather, or is it a possibility that it's the vaccine. The patient's memory is affected, then clarified that it has nothing to do with the vaccine, she is just getting old. She asked if people have reported muscle aches and pains for weeks after. She is due to have the second injection on 08Feb2021. No family medical history relevant to events. The events did not result in emergency room visit or physician office visit. The outcome of the muscle aches and pains was not recovered and was unknown for the rest of the events. Follow-up attempts are completed. No further information is expected.
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| 74 | 2021-04-30 | arthritis, limb discomfort |
slight pain in her arm; her arm was feeling heavy; right where she got the vaccine, just a little, t...
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slight pain in her arm; her arm was feeling heavy; right where she got the vaccine, just a little, there was pain; arthritis; it was not a big swollen, but she saw it in the shower this morning and when she leant on it or presses on it she felt something there; nerve problems; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in left arm on 01Apr2021 11:30 (Batch/Lot number was not reported) at the age of 74 years old as single dose for covid-19 immunisation. Medical history included pain from back and neck surgery she had predating treatment with the vaccine. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 11Mar2021 11:30 am in her left arm at the age of 74 years old for covid-19 immunisation and didn't feel anything different. The patient received the second dose on 01Apr2021 at 11:30 am in her left arm. Reported the first dose she didn't feel anything different. This time she didn't feel anything different until this morning. Added her arm was feeling heavy (Apr2021), she thought maybe she needed to exercise it, and she slept on that side mostly. She reported she was having a slight pain in her arm. Mentioned she also had arthritis and nerve problems (Apr2021). Added it was not swollen, but right where she got the vaccine, just a little, there was pain (Apr2021). She was asking should she just exercise it. Added it was not a big swollen, but she saw it in the shower this morning and when she leant on it or presses on it she felt something there (Apr2021). Added it was young and it had not scattered out yet. She thought the slight pain in her arm started a few days after the second dose of the vaccine, about 05Apr2021, and now it was better than when she first noticed it. Mentioned she was concerned about getting the vaccine because of her other problems but her doctor told her to go ahead and get it. The outcome of the event slight pain in her arm was recovering, of the other events was unknown. Information about lot/batch number has been requested.
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| 74 | 2021-04-30 | muscular weakness |
Severe leg weakness; Went from walking with a cane without any assistance to walking with a walker t...
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Severe leg weakness; Went from walking with a cane without any assistance to walking with a walker to needing a wheelchair any time we leave the house within 4 weeks immediately following the 2nd dose; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 10Mar2021 13:00 as single dose for COVID-19 immunization. Medical history included breast cancer (Breast CA), diabetes, high cholesterol, hypertension (HTN), and known allergies to Sulfa, and Penicillin (PCN) from an unknown date and unknown if ongoing. The patient has no history of covid prior vaccination. Concomitant medications included rosuvastatin calcium (CRESTOR); fulvestrant (FASLODEX); palbociclib (IBRANCE); and metformin, all taken for an unspecified indication. The patient was also reported to be taking BP medication (unspecified) concomitantly. The patient previously took codeine and experienced allergies, and also previously received the first dose of BNT162B2 on 11Feb2021 01:00 PM on right arm, for COVID-19 immunisation. The patient experienced severe leg weakness on 12Mar2021. It was further described that went from walking with a cane without any assistance to walking with a walker to needing a wheelchair any time she leaves the house within 4 weeks immediately following the 2nd dose. As reported, it was a very fast decline. She has trouble ambulating by herself with the walker in the home and cannot be left alone at night. The events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 3 days, and disability or permanent damage. No treatment was received for the events. The patient was COVID tested post vaccination via nasal swab on 11Apr2021with negative results. The outcome of the event was not recovered. Information on the batch/lot number has been requested.
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| 74 | 2021-05-10 | musculoskeletal stiffness |
Soreness at site; stiffness raising arm; fatigue; headache; nausea; chills; This is a spontaneous re...
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Soreness at site; stiffness raising arm; fatigue; headache; nausea; chills; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non- pregnant female patient received BNT162B2 (Pfizer vaccine COVID 19, Solution for injection, Lot number: EL9266 and expiry date was not reported), via an unspecified route of administration in the Arm Right on 15Feb2021 at 10:45 AM (at the age of 74-years-old) as a single dose for COVID-19 immunisation. The patient's medical history had Known allergies (unspecified). The patient's concomitant medications were not reported. Patient didn't receive any other vaccination within 4 weeks of vaccination. Patient received other medications (unspecified) in 2 weeks of vaccination. Patient had no COVID prior vaccination and not tested for COVID post vaccination. On 15Feb2021 the patient experienced Soreness at site and stiffness raising arm, fatigue, headache, nausea, and chills. No treatment was taken for the events. The clinical outcome of the events was recovering.
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| 74 | 2021-05-14 | muscle pain |
Pain in heart area; Can't walk or get out of bed; Headache; Fingers hurt; Occasional tight band arou...
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Pain in heart area; Can't walk or get out of bed; Headache; Fingers hurt; Occasional tight band around chest; Severe muscle pain throughout the body; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 29Apr2021 (at the age of 74 years old) (Lot Number: EN727, unknown expiration) as 1st dose, single for COVID-19 immunization. Medical history included penicillin allergy and diagnosed with COVID-19 (prior to vaccination, was the patient diagnosed with COVID-19: Yes). The patient's concomitant medications were not reported. The patient previously took codeine and experienced codeine allergy. The patient experienced can't walk or get out of bed, headache, fingers hurt, severe muscle pain throughout the body, occasional tight band around chest, and sometimes pain in heart area on 30Apr2021. The patient did not received treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient had not yet recovered from the events. Information on Lot/Batch number was available. Additional information has been requested.
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| 75 | 2021-01-10 | bone pain |
Extreme pain in bone, not muscle, of left arm started approximately 30 minutes after injection. 4 ...
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Extreme pain in bone, not muscle, of left arm started approximately 30 minutes after injection. 4 hours later chills started . Both symptoms continue 12 days later.
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| 75 | 2021-01-13 | bone pain, joint pain |
Her bones were hurting her; hip was hurting more/ pain in hip; Dental implants and bridge fell out; ...
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Her bones were hurting her; hip was hurting more/ pain in hip; Dental implants and bridge fell out; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar event for two patients. This is the 1st of two reports. A 75-years-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Batch/lot number: EK5730), via an unspecified route of administration on 16Dec2020 at single dose for covid-19 immunization (reported as works with COVID patients on daily basis). Medical history included hypertension, hip replacement from an accident four years before 07Jan2021 in December (Dec2016). The patient was not overweight, exercises, was older, but considered in good health. The patient's concomitant medications were not reported. The past vaccine event included weak after the Flu shot. Couple weeks after first vaccine, before new year (Dec2020), dental implants came out. The patient clarified she was referring to dental implants had no pain, had a bridge in her mouth on the left lower side. Felt something was bothering her. Noticed her bridge lifted up and her implants fell out. Had to go to doctor's and had it removed. Everything was moving. She was very uncomfortable. Surgery cost her almost $3,000. Surgery was 3 days before 07Jan2021 (04Jan2021) for her implants and bridge. Had to use bone graft. Her bones were hurting her. After COVID-19 Vaccine, her hip was hurting more. She stated the pain in hip beginning up to one week as of 07Jan2021. The had labs in Dec2020 and everything was ok. The event outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021011233 same reporter/drug, similar event with different patients
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| 75 | 2021-01-18 | joint pain, muscle pain |
injection site pain, very tired kept falling asleep, headache, bad muscle and joint pain, feeling un...
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injection site pain, very tired kept falling asleep, headache, bad muscle and joint pain, feeling unwell and wanting to sleep all day
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| 75 | 2021-01-25 | joint pain | Elevated temperature of 100, chills, joint pain, non productive cough, mild headache, exhaustion. |
| 75 | 2021-01-27 | muscle pain, joint pain |
muscle and joint very sore; muscle and joint very sore; arm shoulder swollen (still on swollen after...
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muscle and joint very sore; muscle and joint very sore; arm shoulder swollen (still on swollen after 3rd day); Fever; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL8982 via an unspecified route of administration on 15Jan2021 10:00 at SINGLE DOSE for covid-19 immunisation. Vaccine location= Left arm, dose number= 1 Medical history included hypertension, blood cholesterol increased, overweight, back pain, hip arthroplasty, spinal operation. Concomitant medication included estradiol (ESTRACE), triamterene (TRIAMTERENE), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), melatonin (MELATONIN). The patient previously took dilaudid and experienced drug hypersensitivity. On 16Jan2021 01:00 patient experienced muscle and joint very sore, arm shoulder swollen (still on swollen after 3rd day), fever, all with outcome of recovering. The action taken was not applicable.
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| 75 | 2021-01-28 | musculoskeletal stiffness, neck pain |
Very painful stiff neck; Very painful stiff neck; rapid heartbeat; This is a spontaneous report from...
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Very painful stiff neck; Very painful stiff neck; rapid heartbeat; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 11Jan2021 13:15 at single dose (left arm) for COVID-19 immunization. The patient had no medical history. The patient had no known allergies and patient was not pregnant. Concomitant medication included gabapentin, diltiazem hydrochloride (DILT-XR), losartan and ezetimibe (ZETIA). On 14Jan2021 at 22:00, the patient experienced very painful stiff neck and rapid heartbeat. The patient had no therapy for the events. The patient had no other vaccine in 4 weeks, and did not have Covid prior vaccination. The patient was no Covid tested post vaccination. Outcome of events was not recovered. Information on Lot/Batch has been requested.
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| 75 | 2021-01-30 | joint pain, muscle pain |
Pfizer-BioNTech COVID-19 Vaccine EUA. Adverse events: chills, joint and muscle pain, nausea and vomi...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Adverse events: chills, joint and muscle pain, nausea and vomiting. Events decreasing after one day.
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| 75 | 2021-01-31 | joint pain | chills, fever, joint pain, headache, tiredness, feeling unwell |
| 75 | 2021-01-31 | muscle pain |
rigors; muscle aches; head ache; pain in my inner ears; photophobia; feeling of exhaustion; too weak...
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rigors; muscle aches; head ache; pain in my inner ears; photophobia; feeling of exhaustion; too weak to walk further than the bathroom; This is a spontaneous report from a contactable other hcp. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 09Jan2021 13:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included benazepril (BENAZEPRIL), diltiazem (DILTIAZEM), rivaroxaban (XARELTO) and estrogen/methyl te. The patient previously had the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 21Dec2020. The patient stated, "I woke from sleep about 12 hours later (10Jan2021) with rigors, muscle aches, head ache and pain in my inner ears as well as photophobia and feeling of exhaustion. The rigors had resolved by 8am but other symptoms persisted. I was too weak to walk further than the bathroom. I was able to consume only warm liquids, although I had no nausea, vomiting or diarrhea. Note that since onset post infectious irritable bowel symptoms in February after visiting a city, weeks before the pandemic was recognized, I have had very abnormal but not absent sense of taste and smell, making me wonder whether I was infected in February without the usual symptoms." The patient recovered from rigors on 10Jan2021, outcome of the event weakness was unknown while other events were not recovered.
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| 75 | 2021-02-01 | muscular weakness |
Nausea, headache, fatigue, lung tightness, muscle heaviness, foggy brain (lack of concentration and ...
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Nausea, headache, fatigue, lung tightness, muscle heaviness, foggy brain (lack of concentration and focus) , GI Increase in bowel movements, general malaise. These symptoms have lasted 6 days so far at varying intensity The lung tightness occurred on day 1 and day 4. The nausea has been persistent. The headache was on day 1 and 3. Foggy brain on day 2 and 5. Fatigue everyday. I am concerned about getting the second shot
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| 75 | 2021-02-03 | limb discomfort |
Sudden onset of left arm heaviness and problems working 3rd and 5th digits of left hand. Admitted ov...
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Sudden onset of left arm heaviness and problems working 3rd and 5th digits of left hand. Admitted overnight for suspected TIA. MRI subsequently confirmed acute to subacute right frontoparietal infarct
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| 75 | 2021-02-04 | joint pain |
Severe shoulder pain. Unable to sleep. Developed over the course of the afternoon and it was 9/10 ...
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Severe shoulder pain. Unable to sleep. Developed over the course of the afternoon and it was 9/10 in severity by evening/bedtime.
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| 75 | 2021-02-04 | joint pain |
severe joint pain; This is a spontaneous report from a contactable consumer (patient). A 75-year-old...
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severe joint pain; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient reported having severe joint pain and she was questioning if she should get the second dose of the vaccine. The second dose is scheduled for 28Jan2021. Outcome of the event was unknown. Information on the lot/ batch number has been requested.
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| 75 | 2021-02-04 | muscle pain |
severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tirednes...
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severe chills; Fever; Dizziness; not feeling quite right; heart pains; Nauseated; threw up; Tiredness; muscle aches; a little swelling in her face; weakness; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK5730) intramuscularly on arm left on 09Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included heart problems from May1966 and ongoing (heart problems/She had open heart surgery at that time and had stents put in a couple of times since then), bone spurs and arthritis in her feet. Concomitant medications were none. Patient used to receive unspecified injections in her feet because she has bone spurs and arthritis in her feet. Patient experienced heart pains in Jan2021, dizziness on 10Jan2021, not feeling quite right on 10Jan2021, severe chills on 11Jan2021, fever on 11Jan2021, nauseated in Jan2021, threw up in Jan2021, tiredness in Jan2021, muscle aches in Jan2021, a little swelling in her face in Jan2021, weakness in Jan2021. The outcome of the events was unknown. Patient received her first Pfizer vaccine on 09Jan2021. Patient explains she has had adverse reactions to the vaccine ever since she received it. Patient confirms she took the vaccine on Saturday, 09Jan2021. On Sunday, 10Jan2021, she started having a little bit of dizziness and feeling just not quite right. Sunday night, she went to bed and woke up at around 3:30 a.m. with severe chills and a fever. Her fever was a little over a 100. She states it took about 2 hours to get her chills under control. She took 2 Tylenol at that time. That day (11Jan2021) she ran fever off and on all day. The next day (12Jan2021), she seemed to be better. She had a low-grade fever, but she was better. She was just kind of tired from the day before. But then, that night, she ended up with the same thing again- she woke up at 4am with chills. Her fever had gone up 101.7, and she ended up taking 2 Tylenol and so forth. She got up that morning around 10 am, and was nauseated. She threw up that morning. She felt really bad. She was experiencing tiredness, muscle aches. (At this point it was about Tuesday (12 Jan) or Wednesday (13 Jan). There was one day during the day, she felt better, but a day went by and she ended up having the chills and fever again. Every time her fever kept going up. Her fever this particular night was 102 something. About Wednesday night, when she had the chills and fever, her fever went up to 103.8. That next morning, she called her doctor's office and tried to get an appointment. She could not get an appointment with the office. Her office ended up doing a televist and sending her a Prednisone pack to take for the reaction that it seemed she was having. She started the prednisone pack which seemed to take the fever down and the chills ended up stopping. Caller clarifies further she believes she has recovered from the fever and chills. The Prednisone pack seemed to kind of make those symptoms go away. However, she still felt really bad. This went on all weekend again. Tuesday of this week, (19Jan2021), she still felt really bad. She called her doctor again and her doctor wouldn't see her because of the symptoms she is having after receiving the COVID-19 vaccine are the same symptoms of the actual COVID-19 virus. She clarifies further the adverse effects of the shot are also same ones as the COVID-19 virus. Her doctor suggested she either go to the Emergency Room or to an Urgent Care. Patient called the Urgent Care and they were able to do a COVID test on her to check and see if she did have COVID-19. She confirms this test was on Tuesday, 19Jan2021. The results came back negative. However, they did another swab test. The patient is unsure what the second swab test was for but was told it would be a couple days before they would have the results of this test. At this point, they put her on a Z-pak. Patient mentions she has heart problems. She has nitroglycerin for any problems that she has. She started having some heart pains when she was down to about 3 tablets of that Prednisone pack she was taking. When she took one of the Prednisone tablets, within 30 minutes of taking it, she started having chest pains. She clarifies it started in her throat and went down to her chest. She took 2 nitroglycerin's to get her feeling back to normal/better. Caller doesn't provide NDC, Lot number or expiration date for the Nitroglycerin she took when probed. Patient mentions her cheeks had been pink. She doesn't really know but she may have a little swelling in her face. She can't figure that out herself. She was experiencing dizziness and weakness. Today is the first day which is the 13th day after receiving the vaccine, she has felt like trying to get this stuff together and her thoughts together to try and figure out what is going on with her. She tried calling her primary doctor and this urgent care and she couldn't get anybody to see her. Patient got her Prednisone pack filled at (Pharmacy name), (Address details) The prescription was issued to her on Thursday, 14Jan2021, but she didn't start taking the pack until Saturday. On Saturday, that's when her fever had went up to 103 and she knew she needed to take the Prednisone pack. They are 4mg tablets and she started out taking 6 tablets the first day and then her dose decreased every day. NDC: 164793723369, Lot: 20K0041P, she believes the second digit is a zero and not a "D", Expiry date: Aug2022. Z-pak: patient states she no longer has the box, therefore she is not sure of the dose and how it was prescribed. She makes the comment she believes the first day it was 2 tablets. NDC: Unknown, Lot: 7996030, Expiry: Feb2022. She clarifies she did not take Tylenol as stated earlier. She took Kirkland's brand, Acetaminophen. They are 500mg tablets. She provides the following product information: Lot: 2GE1779B. The last digit is either a "B" or an 8/, Expiry date: May2015; patient clarifies she knows they just bought this bottle, but she thinks her husband put his extra pills in the wrong bottle. No further details were provided or obtained in regard to this statement. The patient wants to find out about this and what is going on with her. To her understanding and her reading information, she is scheduled to take her next shot 27Jan2021. She is not supposed to take it then, correct? Investigations: patient confirms she had a COVID-19 test done (she is not sure what type of test- PCR, Antibody, etc), they swabbed her nose and the results came back negative. She had a second test done, where they swabbed her nose again, but she hasn't got the results back. She isn't sure what that test is for. Vaccination Facility Type was Hospital. Additional Vaccines Administered on Same Date of the Pfizer Suspect was no. Did any AE(s) require a visit to: Emergency Room was No, she is trying to keep herself out of the hospital. Physician Office? Her doctor would not see her but offered a virtual visit. She did go to the Urgent Care. Prior Vaccinations (within 4 weeks): Caller states she went to the foot doctor on 22Dec2021 (pending clarification). She was given injections in her feet because she has bone spurs and arthritis in her feet. Patient does not know exactly what kind of injection it was. She confirms she has no name, ndc, lot and expiry date for the injections she received. Patient asks the call handler, what should she have done on this? She was lost. She read the information that was provided to her and she doesn't feel there was sufficient information on what to do if you had a reaction. She guesses the best thing she can be told is to call #. She didn't know it was a # emergency. She didn't know what she was supposed to do. It was hard for her to get any information out of anybody as to what to do. The outcome of the events was unknown.
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| 75 | 2021-02-07 | joint pain, muscle pain | Chills, muscle pain, joint pain, bad headache, fever reaching 101 (I am usually about 97.2) |
| 75 | 2021-02-07 | joint pain |
Very tired & intense joint pain all night. Next day, chills & flu like symptoms (a very upset stomac...
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Very tired & intense joint pain all night. Next day, chills & flu like symptoms (a very upset stomach) After 48 hours, side effects disappeared completely.
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| 75 | 2021-02-07 | muscle pain |
accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; ...
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accompanied with very severe chest pain; Pericarditis; woke up with a severe headache; severe pain; continues to have muscle pain; weakness; shortness of breath when she walks; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (lot number and expiry date not provided), via an unspecified route of administration on 15Jan2021 10:30 at single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. On 16Jan2021 04:00, she went to bed at night and woke up at 4 AM with a severe headache. She took Aleve and went back to bed. When she woke up at 8:30 AM her headache was very severe and was accompanied with very severe chest pain. She immediately took her to the ER. They did a very thorough work up to check on her heart and Aorta. They managed her severe pain with two doses of morphine followed by two days of Dilaudid. The imaging and symptoms left her with a newly discovered diagnosis of Pericarditis. The medical professions were sure this was a result of the COVID vaccine. They continued to treat her for a few days and sent her home with anti inflammatories to help. She continues to have muscle pain, weakness and shortness of breath when she walks. She is scheduled to take her 2nd dose on February 5th but we are very concerned and hesitant as we don't want to cause any more damage to her heart. The patient was hospitalized for events 'headache', 'chest pain;', 'pericarditis' and 'pain' for 4 days. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not received any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included imaging: pericarditis on 16Jan2021 and Nasal Swab: negative on 16Jan2021. Therapeutic measures were taken as a result of all the events which included Colchicine and prednisone, morphine and dilaudid. The outcome of the events was recovering. The events "headache", "chest pain", "pericarditis"and "severe pain" were assessed as serious due to hospitalization and disability. The events "myalgia", "asthenia" and "dyspnea" were assessed as serious due to disability. The events ('headache', 'chest pain;', 'pericarditis' and 'pain') resulted in emergency room visit. Information on the lot/batch number has been requested.
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| 75 | 2021-02-07 | neck pain |
At 9:55 am, five minutes post vaccine, patient reports to observation nurse feeling dizzy, left side...
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At 9:55 am, five minutes post vaccine, patient reports to observation nurse feeling dizzy, left sided neck pain, flush, and sudden left sided headache. Staff was notified EMS crew immediately. B/P 151/83, Also diapheretic. Patient reported not feeling well at all and would like to go to the hospital. Transported to local hospital. for evaluation
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| 75 | 2021-02-08 | muscle pain |
Diarhea, vomiting, chills, sweats, mild rash all over the body, injection site pain and swelling, mu...
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Diarhea, vomiting, chills, sweats, mild rash all over the body, injection site pain and swelling, muscle soreness.
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| 75 | 2021-02-09 | joint pain | Slight headache; joints aching mild; temperature -100.2 |
| 75 | 2021-02-09 | joint pain |
Joint pain; arm hurt; felt wiped out; This is a spontaneous report from a contactable consumer. A 7...
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Joint pain; arm hurt; felt wiped out; This is a spontaneous report from a contactable consumer. A 75-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3246), intramuscular on 02Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient was calling about the Covid-19 vaccine and reported that she had the 2 shots. She said that after both shots, her arm hurt, she felt wiped out, and she had joint pain. She felt more tired for 3 full days after the first shot and after the second shot she was just wiped out for 1.5 days. The patient said that after the first vaccine, she had not had knee surgery, but before the second the second vaccine she had knee surgery. The patient clarified that it was a knee replacement on 12Jan2021. The outcome of the events was unknown.
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| 75 | 2021-02-09 | joint pain |
felt wiped out; Joint pain; Fever as high as 100; arm hurt; This is a spontaneous report from a cont...
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felt wiped out; Joint pain; Fever as high as 100; arm hurt; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261) intramuscular, on 22Jan2021 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 75 years. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246) received on 02Jan2021 at single dose. Relevant medical history included COVID-19 last Mar2020 and knee replacement on 12Jan2021. The patient received no concomitant medications. The patient reported she had the 2 shots. After both shots, her arm hurt, she felt wiped out, and she had joint pain. After the second shot, she did run a fever as high as 100. She said that she had the second shot on Friday 22Jan2021 and on Saturday she was wiped out. She felt more tired for 3 full days after the first shot and after the second shot she was just wiped out for 1.5 days. The event wiped out had resolved in Jan2021, while outcome of other events was unknown.
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| 75 | 2021-02-09 | muscular weakness |
Pfizer-BioNTech COVID-19 Vaccine EUA Weakness in legs, and headache stated about six hours ago, and...
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Pfizer-BioNTech COVID-19 Vaccine EUA Weakness in legs, and headache stated about six hours ago, and continuing.
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| 75 | 2021-02-09 | musculoskeletal stiffness, joint pain |
really bad chills; fever; joint pain; soreness/achiness; she was really stiff and she could not walk...
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really bad chills; fever; joint pain; soreness/achiness; she was really stiff and she could not walk real good; she was really stiff and she could not walk real good; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247, expiration date May2021), intramuscularly on right arm on 23Jan2021 10:50 at 0.3 mL single for COVID-19 immunization. Medical history included ongoing arthritis, right knee replacement from Aug2019 to an unknown date, ongoing high blood pressure, a long list of antibiotics that she was allergic to/certain types of mycin, allergic to penicillin, covid-19 from 23Dec2020 to an unknown date. Concomitant medications included unspecified a lot of medications. The patient previously took flu vaccine in 2020 for immunization, codeine and experienced drug allergy (she cannot take codeine), norvasc and experienced drug allergy (certain types of mycin, several types of blood pressure medication like norvasc). The patient woke up early at 6:00am on 24Jan2021 with really bad chills, fever and joint pain. Her temperature was 101.6 after taking Tylenol. Her arm felt like there was a small "know" in it. Some soreness, but feeling better. The patient had a really bad day yesterday on 24Jan2021, she experienced really hard chills about 5 or 6 episodes of chills. Her temperature got up to 101.6 and that was with Tylenol. She felt better today and her temperature was back to normal on 25Jan2021. She had soreness, achiness, she was still sore in regards to her muscle. She got over covid. She was diagnosed with covid on 23Dec2020, about 30 days ago. She got the first dose of the vaccine on 23Jan2021 and she was scheduled then since she was told to wait about 30 days after being diagnosed with COVID. She heard the second shot might be more intense and asks if that was right. She called the doctor. When querying lot number, she put her glasses back on to read the stamp on the card. She had to get under the lamp since it was kind of blurry. She could not read the lot number on the card and had to get a magnifying glass and then was able to provide lot. The first episode of chills happened during the night and woke her up about 6 am on 24Jan2021, when she got up she was really stiff and she could not walk real good. She had to hold on to something when she got up to go to the bathroom. The chills that were so bad were yesterday from 11 till about 4 or 5. Around 6 or 7 pm yesterday she had lighter chills. She got real red in the face since she was hot and her temperature was going up. Reported she took Tylenol earlier than she should have taken it since it was scaring her. Her temperature was good since she woke up. It was about 100 when she went to bed last night on 24Jan2021. The achiness and soreness started when she got up around 6am yesterday and it was still there but much better. Reports she had arthritis and her joints were sore anyways but this soreness was more. She had a lot of medication that she takes but does not feel they are relevant to provide at this time. The outcome of events joint pain and pain was recovering. The outcome of event fever was recovered on 25Jan2021. The outcome of event chills was recovered in Jan2021. The outcome of rest events was unknown.
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| 75 | 2021-02-10 | back pain |
Approximately 35 red spots about 1/4 inch each with a pinhead sized head appeared across stomach and...
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Approximately 35 red spots about 1/4 inch each with a pinhead sized head appeared across stomach and reaching around to back on right and left sides of trunk. Spots were observed at bedtime, Not sure when they first appeared. No itching. Roof of mouth and gums were sore later in the night and mild headache occurred. Spots started disappearing on their own over the course of a week.
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| 75 | 2021-02-10 | muscle pain, joint pain |
muscle aches; nausea; vomiting; weakness; chills; Diarrhea; Joint pain; It scared me that I was so s...
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muscle aches; nausea; vomiting; weakness; chills; Diarrhea; Joint pain; It scared me that I was so sick.; Slight headache like a little pressure on her head / Horrible headache; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number EL9262 (the patient was not sure of the second letter), via an unspecified route of administration in left arm on 23Jan2021 at 16:15 at single dose for COVID-19 immunization. Medical history included sinus infection. The patient was not pregnant at the time of vaccination. Facility where the COVID-19 vaccine was administered was Hospital. The patient has not been tested for COVID-19 since the vaccination. Concomitant medication included amoxicillin, clavulanic acid (AUGMENTINE) for sinus infection and pravastatin. The patient stated that when she went home after vaccination, she had a slight headache, like a little pressure on her head when she went to bed but that was supposed to be normal. So, she went to sleep and the next morning she woke up and she had every single side effects: the nausea was horrible, she must have thrown up 15 times, she had diarrhea and joint pain. She did not think she had any fever but she did had chills and muscle pain, weakness and had horrible headache. The events onset date was reported as 24Jan2021 at 12:00 AM (except for headache which started on 23Jan2021). No treatment was administered for these events. The patient stated that it scared her that she was so sick. All the reported events were assessed as non-serious. The patient reported that 3 days later she was still feeling very weak. At the time of the report the events headache, muscle aches, nausea, vomiting and chills had recovered with sequelae, the event weakness had not yet resolved, whereas the outcome of the events diarrhea, joint pain and sickness was unknown.
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| 75 | 2021-02-11 | back pain, joint pain |
Beginning 4 days after shot and running for 8 days, had significant abdominal aches, pains in hip, p...
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Beginning 4 days after shot and running for 8 days, had significant abdominal aches, pains in hip, pelvic areas as well as mid-spine to limbo-sacral areas. Temperature range 96.2 to 100.8, night sweats. At times had hard time getting around, e.g. standing straight, bending, getting into bed, moving around in bed. Pain moved around - intense in one area and then 6 hours later, intense in another area. Pain range 2 - 7 on scale of 0-10. Sleep interrupted for 8 nights sometimes for long stretches. Normally active, flexible, healthy, mentally alert, more like a 50 year old. Weight appropriate for height. Eat well and pay attention to staying healthy. Don't like taking medication, so only took one tylenol when temp got to 100.8.
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| 75 | 2021-02-13 | muscular weakness |
Patient presented on 1/24 with acute onset weakness and numbness of the left leg so a stroke alert w...
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Patient presented on 1/24 with acute onset weakness and numbness of the left leg so a stroke alert was activated. NIHSS 3. Head Ct and CTA head/neck were unremarkable. Not a candidate for tPA given on Eliquis. Initial exam was notable for weakness and sensory loss in the left leg, but a sensory level was also found to the umbilicus raising concern for a myelitis. Of note, the patient also reported that certain red colored things she looked at appeared black. Labs unrevealing- CBC, CMP unremarkable. ESR, CRP normal. UA and UCx positive for E. Coli UTI, she was treated with ceftriaxone. MRIs were done of her brain, cervical and thoracic spine which were unrevealing. On 1/25, her exam worsened including worsening weakness in the left leg and new numbness and paresthesias in the right leg. Reflexes were preserved. MRI L spine was done which was unrevealing. Lumbar puncture was done which showed 2 nucleated cells and mildly elevated protein at 50, but was otherwise unrevealing. IgG Index normal. No oligoclonal bands. She developed mild hyperreflexia in the left leg and continued to have a sensory level, now at around T5-6. Repeat imaging of her cervical and thoracic spine were completed on 1/28 which showed a contrast enhancing hyperintensity at T5. The patient was diagnosed with myelitis and she was started on IV methylprednisolone x5 days and sent to rehab. Patient is now significantly improved though continues to report some numbness in the left leg.
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| 75 | 2021-02-15 | muscular weakness |
Chills and muscle weakness that started on 2/13 PM and then mom suffered a basal ganglia stroke on 2...
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Chills and muscle weakness that started on 2/13 PM and then mom suffered a basal ganglia stroke on 2/14 PM.
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| 75 | 2021-02-15 | musculoskeletal stiffness, joint pain |
Stiff neck & pain across shoulders. Couldn't move them at all & couldn't even turn over in bed, so ...
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Stiff neck & pain across shoulders. Couldn't move them at all & couldn't even turn over in bed, so lack of sleep for the first five days. The pain eventually went away, but neck still a bit stiff. I took every OTC medication I had in the house...Tylenol, Advil, Aleve, Motrin, etc. & heating pad & ice packs. Only the ice packs gave me temporary relief.
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| 75 | 2021-02-17 | bone pain, muscle pain |
Severe pain in muscles, bones, stomach and intestines. Severe chills, to the point that the chatter...
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Severe pain in muscles, bones, stomach and intestines. Severe chills, to the point that the chattering chipped a tooth. Diarrhea, vomiting, to the point that I was unable to keep even water down for about the first 36 hours. The shaking subsided, but the chills and severe muscle pain continued for three days. My bowels are still painful after three full days, but skin and muscle pain has subsided. During the three days of pain, I slept about 20 out of 24 hours. When awake, I tried to read but was unable to concentrate. Same for TV.
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| 75 | 2021-02-18 | musculoskeletal stiffness |
Felt like my metabolism was racing - couldn't relax to go to sleep. When that stopped, aches at all ...
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Felt like my metabolism was racing - couldn't relax to go to sleep. When that stopped, aches at all sites where I had previous injury - knee replacement, other knee, fingers that locked. Felt fuzzy and tired the next day 2/18/2021. Felt normal by 2/19/2021.
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| 75 | 2021-02-18 | muscle pain | Flu-like symptoms, muscle aches, chills, feeling unwell |
| 75 | 2021-02-19 | back pain |
Pain in left mid-thigh, and pain in left lower back pelvic area. Taking Advil during past four days...
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Pain in left mid-thigh, and pain in left lower back pelvic area. Taking Advil during past four days. Appointment with orthopedist is scheduled for 02/22/2021.
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| 75 | 2021-02-19 | muscle pain, joint pain |
Approximately 12 hrs after vaccine I started having chills, severe joint and muscle pain, headache, ...
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Approximately 12 hrs after vaccine I started having chills, severe joint and muscle pain, headache, nausea, and pain in the left arm at the injection sight. About 24 hrs after the injection I started having a fever which got as high as 103? I still feel unwell, am very tired?52 hrs after the injection..
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| 75 | 2021-02-22 | muscular weakness | Severe shakiness - muscle weakness in legs Symptoms still persist today |
| 75 | 2021-02-22 | muscular weakness |
Patient called stating she received the second Pfizer vaccine on 2/21. That evening, she developed s...
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Patient called stating she received the second Pfizer vaccine on 2/21. That evening, she developed severe generalized weakness. She was unable to walk or stand. She laid on the floor from 2/21 3pm until 2/22 PM. She was incontinent of urine- reports urinating on towels throughout yesterday. She was unable to hold her head up due to weakness. She still feels weak today, but is able to stand and walk with husband's assistance. Also reports generalized muscle soreness and intermittent vertigo. She is drinking fluids well, has eaten a light meal today. Denies fever, shortness of breath, chest pain, palpitations.
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| 75 | 2021-02-23 | muscle pain |
Evening Feb. 15, chills, fever, muscle aches, and headache and exhaustion. Night sweats with tem...
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Evening Feb. 15, chills, fever, muscle aches, and headache and exhaustion. Night sweats with temp. up to 101.8. Day temps 99 to 100. Have lasted to the present time. Treatment fluids and aspirin. Chest x-ray and urinalysis clear. Covid nasal test yesterday, Feb.23. The second Pfizer vaccine scheduled for today, Feb. 24, was cancelled.
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| 75 | 2021-02-25 | weight decreased |
Patient had COVID shot on 2/5/21 Friday afternoon and waited her observation period. She started hav...
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Patient had COVID shot on 2/5/21 Friday afternoon and waited her observation period. She started having a sharp chest pain on drive home. She pulled over and the feeling went away. No other symptoms. On sat morning patient started getting twinges of chest pain on left side bottom by her breast. On Saturday night and Sunday morning patient started belching. She doesn't normally have belching. This morning patient felt like her heart racing. She is still having a chest pressure. Was sent to ED 2/8/21 after triage. Labs unremarkable, troponin negative, instructed to f/u with PCP, discharged in stable condition. F/U w/ PCP 2 weeks later and reported weight loss, weakness, possible facial droop (although not noticed today on exam). Symptoms appear to be improved.
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| 75 | 2021-02-26 | joint pain |
first dose in left arm couple of days later right hip is in pain all the time, had x-ray on 2/21 and...
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first dose in left arm couple of days later right hip is in pain all the time, had x-ray on 2/21 and going back to doctor to find out results
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| 75 | 2021-02-27 | joint pain, muscular weakness |
Tingling /numb hands and feet, tired, no energy, night sweats, abdominal pain, burning on bottom of ...
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Tingling /numb hands and feet, tired, no energy, night sweats, abdominal pain, burning on bottom of feet, muscle weakness, dry mouth, joint pain, headache,...
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| 75 | 2021-02-27 | neck pain |
Had no pain in arm or redness for the first 10 days. Developed severe pain in my arm from the injec...
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Had no pain in arm or redness for the first 10 days. Developed severe pain in my arm from the injection sight up to my ear and neck. The pain in my neck stayed for 9 days with pain to my arm that was terribly painfull. Now I still have an ache in my neck and arm that is mild but also feels very tired like if you had a neck injury from nerve pain
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| 75 | 2021-02-28 | joint pain, joint swelling |
Severe knee and leg pain, spasms and swelling in the knee and ankle on just one leg. . Started two d...
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Severe knee and leg pain, spasms and swelling in the knee and ankle on just one leg. . Started two days after receiving the Covid19 vaccine. Great difficulty walking. without assistance. Pain began to subside on the fourth day and is less intense today, the fifth day following vaccination but is still present.
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| 75 | 2021-02-28 | joint pain | I experienced extreme pain in all muscles/joints for a period of 24 hours. |
| 75 | 2021-02-28 | muscle pain, joint pain |
Injection site pain, Chills, 102 fever 24 hours for 3 days, headache, tiredness, muscle pain, joint ...
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Injection site pain, Chills, 102 fever 24 hours for 3 days, headache, tiredness, muscle pain, joint pain, feeling unwell
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| 75 | 2021-02-28 | muscle pain |
On day after had severe muscle ache; severe headache; nauseous; so cold (could not get warm); had a ...
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On day after had severe muscle ache; severe headache; nauseous; so cold (could not get warm); had a fever; slept for 15 hours; This is a spontaneous report from a contactable consumer. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration on 26Jan2021 17:00 at single dose for covid-19 immunisation. Medical history included mitral valve prolapse and COVID-19. Concomitant medication included bimatoprost (LUMIGAN), colecalciferol (D3), zinc (ZINC), and ubidecarenone (COQ10). The patient experienced severe muscle ache, severe headache, nauseous, so cold (could not get warm), had a fever and slept for 15 hours on 26Jan2021 21:00. The patient received no treatment. The outcome of the events was recovered with sequelae on an unspecified date.
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| 75 | 2021-03-01 | muscle pain |
Body and muscular aches in entire body. Slight headache. Extreme fatigue. Symptoms continued From 1...
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Body and muscular aches in entire body. Slight headache. Extreme fatigue. Symptoms continued From 1:30 am on 2/26 for approximately 24 hours.
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| 75 | 2021-03-01 | neck pain |
itching tongue face lips, mild swollen tongue and lips, neck pain, hoarse voice, cough, pale. Pr...
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itching tongue face lips, mild swollen tongue and lips, neck pain, hoarse voice, cough, pale. Progressively worse in order listed over 10 minutes. Chewable benadryl 12.5 mg x 4 given. Pt reported improved symptoms within 10 minutes and was asymptomatic at 30 minutes.
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| 75 | 2021-03-01 | rheumatoid arthritis, joint pain |
Started coughing one week after receiving vaccine. Then woke up next morning with sore throat, "coul...
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Started coughing one week after receiving vaccine. Then woke up next morning with sore throat, "couldn't swallow." The symptoms "wouldn't let up" then patient reports by Saturday Feb 20, she felt "washed out," couldn't breathe, lost all energy, and had a RA attack. Her knees are still throbbing today.
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| 75 | 2021-03-02 | muscle pain, joint pain |
it showed a "CRP value" of 11.5 which is usually below 0.29 which shows inflammation; loss of appeti...
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it showed a "CRP value" of 11.5 which is usually below 0.29 which shows inflammation; loss of appetite; Nausea; breathing problems; mild fever; Muscle ache; Joint ache; Rapid heart rate up to 130; Itchy skin; roof of mouth itching; eyes were also really sore; This is a spontaneous report from a contactable Other HCP (patient). A 75-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6201), via an unspecified route of administration in the right arm on 11Feb2021 at single dose for COVID-19 immunisation. Medical history included ongoing asthma initially diagnosed at 21 years old, ongoing arthritis diagnosed 10-15 years before but she thinks she had it since she was 35, multiple joint replacements, past pneumonia. The patient's concomitant medications were not reported. The patient previously received methotrexate 25mg a week orally for arthritis but she quit taking it about 3 months before in preparation of getting the vaccine. The patient previously received the first dose of bnt162b2 on unspecified date (lot EL8982) at single dose for COVID-19 immunisation in the right arm. The patient experienced mild fever on 12Feb2021 with outcome of recovered on 14Feb2021, roof of mouth itching on 11Feb2021 with outcome of recovered on 11Feb2021, muscle ache on 12Feb2021 with outcome of recovered on 12Feb2021, joint ache on 12Feb2021 with outcome of recovering, breathing problems on 12Feb2021 with outcome of recovering, rapid heart rate up to 130 on 12Feb2021 with outcome of recovering, itchy skin on 11Feb2021 with outcome of recovered on 11Feb2021, it showed a "crp value" of 11.5 which is usually below 0.29 on 15Feb2021 with outcome of unknown, nausea on 12Feb2021 with outcome of recovered on 13Feb2021, loss of appetite on 13Feb2021 with outcome of recovered on 13Feb2021, eyes were also really sore on 11Feb2021 with outcome of recovered on 15Feb2021. An EKG performed on 15Feb2021 as pending results. The event of breathing problems was serious due to disability. The events mild fever, roof of mouth itching, muscle ache, joint ache, rapid heart rate up to 130 and itchy skin were medically significant. The patient reported that initially, the roof of her mouth started itching. It literally happened as soon as she had the vaccine. She took a Benadryl. She didn't have a skin irruption, but did have itchy skin. The next day, she had a low grade fever. She had muscle and joint aches. She had no rash, but a little nausea. She had breathing problems. She had asthma issues and wheezing after the vaccine. That is how she described her breathing issues. She had a rapid heart rate. It went up to 130. It could of been because of fever, her breathing, or pain. There was a period of days then it resolved. On 15Feb2021, she feels almost human. She had routine arthritis lab drawn on 15Feb2021. They showed a CRP level of 11.5 which shows inflammation. She normally was below 0.29 which was within normal limits. That was an extreme difference. That was a lot of inflammation. The patient had to get her nebulizer out to breathe. She has taken Tylenol a couple of times. Her lab work was essentially normal. The CBC and chemical panel was okay. The patient thoughts the fever was important because she has been immunocompromised for years by Methotrexate. She has had pneumonia before with no fevers. Her eyes were also really sore. They bothered her. She already had to use eye drops. That was 11Feb2021 it was gone on 15Feb2021 but it kind of lasted a few days. Her muscles were better, but her joints still hurt some. But her joints always hurt some. She has had multiple joint replacements. The muscles in her legs were severe Friday and Saturday. Her muscles aren't hurting now, but her joints were but that was kind of normal. Her peak flow was way down on 14Feb2021. It was at 250. She did finally get it up to 350 by using her nebulizer. Her best effort normally is 450. Her peak flow was down quite a bit. She has been having breathing changes for a year. They were not sure what it was about. It could be an acute episode of something. On unknown date (next morning as reported), her pulse was 90-100. Now her heart rate was only elevated with activity. Her heart rate was down in the 70s, but when moving it was in the low 100s. With activity it was still up. It was hanging out in the 70s except exercising. She considers walking across the room exercising. All her other labs were in within normal limits. The patient wanted to know if the inflammatory response was secondary to the vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 75 | 2021-03-02 | muscle pain |
AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarifie...
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AFib; Tingling sensation maybe her sinuses; Headache; Sore throat; Upper chest pain; aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); aches (clarified as body or muscle ache in her arm or leg that occurred occasionally); Nausea; Heart pounding; Lightheadedness; tingling feeling below her neck on the flat area of her upper chest; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 28Jan2021 11:00 at a single dose for COVID-19 immunisation. Medical history included Afib (diagnosed about 4-5 years ago) and stress. There were no concomitant medications. It was reported that when she got her first COVID-19 Vaccine, her arm didn't hurt, but she had a headache, sore throat, an upper throat and chest type of thing, aches (clarified as body or muscle ache in her arm or leg that occurred occasionally), a little nausea, heart pounding, and lightheadedness on an unspecified date in Feb2021. She said she has AFib (atrial fibrillation) on an unspecified date. She said she is scheduled to get her second COVID-19 Vaccine shot next Monday (22Feb2021), and wanted to know if her side effects are going to be worse. She clarified that her upper throat and chest type thing to be a tingling feeling below her neck on the flat area of her upper chest on an unspecified date in Feb2021. She said she spoke with her doctor on a video call. She said her doctor said her tingling sensation would not be from the COVID-19 Vaccine shot, and the tingling sensation maybe her sinuses on an unspecified date. She said her doctor put her on antibiotics for 10 days (prescribed Cephalexin 500mg capsules, twice a day for 10 days. She said she started the Cephalexin 500mg capsules on 05Feb2021 and finished the prescription yesterday, 15Feb2021. She said the Cephalexin 500mg capsules were dispensed in a pharmacy bottle). The patient stated that she has no other medical conditions, except stress. She said she and her husband have been quarantined, and the quarantine has felt like the longest 2 weeks of her life. It was reported that the patient still gets heart palpitations. She said the other side effects lasted 5-7 days, and improved during that time. She said the side effects have all resolved with the exception of the heart palpitations. The event atrial fibrillation was assessed as serious (medically significant). The outcome of the event heart pounding was not recovered, while recovered on an unspecified date in Feb2021 for the rest of the events.
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| 75 | 2021-03-03 | musculoskeletal discomfort, muscle pain, musculoskeletal stiffness |
sore muscle around my neck; when in bed last night, she could not turn her head without it been so p...
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sore muscle around my neck; when in bed last night, she could not turn her head without it been so painful; had discomfort in her shoulder and stiffness; had discomfort in her shoulder and stiffness/neck was so stiff that it hurt to turn her/can hardly turn her neck; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264), via an unspecified route of administration on 30Jan2021 at 16:10 (4:10 pm) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Jan2021, the same night of vaccination, the patient had discomfort in her shoulder and stiffness. On Monday, 01Feb2021, patient reported that her "neck was so stiff that it hurt to turn her head". She can hardly turn her neck. She added when in an "upright" position "it is ok" but "when in bed last night, she could not turn her head without it been so painful" to the point where she felt like she "would cry out". On an unspecified date it was reported that patient had sore muscle around my neck. The patient mentioned she alleviates her pain with "Tylenol, hot compresses, took a towel and put hot water on it and then put it around my neck, and a cream for soreness". The patient took a Tylenol last night and put hot compress on it. And rubbed it with a muscle something for a sore muscle. But it still very painful. The patient doesn't know whether it's related to the vaccine or not. The outcome of the event sore muscle was not recovered while for the rest of the events was unknown.
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| 75 | 2021-03-04 | muscle pain |
My mother had the COVID vaccine at 9 am. By 7:30 pm she felt weak, had muscles aches and severe head...
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My mother had the COVID vaccine at 9 am. By 7:30 pm she felt weak, had muscles aches and severe headache. As the night continued on she had fever chills that would come and go all night causing her not to get much sleep. Day two the chills were gone but still very achey, weak, tired and headache. Day three she is still tired and weak with headache.
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| 75 | 2021-03-05 | muscle pain |
Was skiing on mountain - became extremely tired, muscles in legs hurting badly, back pain for 5 days...
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Was skiing on mountain - became extremely tired, muscles in legs hurting badly, back pain for 5 days before increased, Could hardly move, shortness of breath , had to stop constantly to get down the slopes to condo, very weak, laid down on bed, had chills and sweats off and on, felt achy all over - could hardly move around - in other words had symptoms of Covid 19 slept overnight. The next morning was much better although still a bit tired. It was very scary but I realized that it was a reaction to the vaccination.
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| 75 | 2021-03-06 | joint pain |
On the morning after receiving the shot I came down with severe pain throughout my body and especial...
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On the morning after receiving the shot I came down with severe pain throughout my body and especially in both hips, along with fatigue. I was basically unable to get out of bed for 48 hours when the pain subsided.
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| 75 | 2021-03-07 | joint pain, muscle pain |
After 5 days of the injection (2/22/21) had sore arm and then pain in the muscle and also the joint ...
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After 5 days of the injection (2/22/21) had sore arm and then pain in the muscle and also the joint of her shoulder. She has a sharp pain when she moves her arm in certain positions,. Goes from a muscle soreness to a sharp stabbing pain. She went to her doctor and he said that it was from the vaccine and not her rheumatoid arthritis.
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| 75 | 2021-03-07 | joint pain |
Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms;...
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Cold sweat; Within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms; Headache; Diarrhea; Chills; Tenderness where the shot area is; Joint pain; Really bad flu; A little bit of a rash from it because my skin is all red from itching; A little bit of a rash from it because my skin is all red from itching; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EN5318), via an unspecified route of administration on 02Feb2021 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included high cholesterol and eye disorder. Concomitant medication included atorvastatin, ubidecarenone (COQ-10), colecalciferol (VITAMIN D3), cyanocobalamin (VITAMIN B12), monascus purpureus (RED YEAST RICE) and unspecified OCUVITE for the eyes. On 02Feb2021 at 14:30, within 15 minutes of the vaccination, the patient was itching really bad (itchy in the ears, scalp, neck, chest, arms). The patient was kept in observation after the vaccination for an hour and was treated with diphenhydramine (BENADRYL) which did not seem to help. The patient drover home and went to bed. Her physician suggested that she see an allergist. The allergist was not sure what was in the vaccine and requested the patient ask her doctor for another referral. On 02Feb2021, the patient also experienced headache; diarrhea; chills; tenderness where the shot area was. On 03Feb2021, the patient woke up with cold sweats, like cold wet perspirations and chills again. On an unspecified date in Feb2021, the patient experienced joint pain and felt like she had a really bad flu, developed a little bit of a rash because the skin was all red from the itching, which she couldn't stop. The patient reported that she was treated for the events with diphenhydramine and paracetamol (TYLENOL). She questioned whether there were other reports of itchiness. The clinical outcome of "within 15 minutes, started itching really bad / Itchy in ears, scalp, neck, chest, arms", headache, diarrhea, chills, cold sweat was not resolved; while "tenderness where the shot area is", joint pain, really bad flu, "a little bit of a rash from it because my skin is all red from itching" was unknown.
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| 75 | 2021-03-08 | joint pain, joint swelling, arthritis |
arthritis; fingers on right were all swollen; she could barely move her arm; right hand and wrist wa...
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arthritis; fingers on right were all swollen; she could barely move her arm; right hand and wrist was painful and swollen; right hand and wrist was painful and swollen; right hand and wrist was painful and swollen; right hand and wrist was painful and swollen; light headache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), via an unspecified route of administration on 26Jan2021 at 10:40 (at the age of 75-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included arthritis from an unknown date, renal cancer since 07Dec2020 and ongoing, atrial fibrillation since 2006 and ongoing, partial nephrectomy on 06 Jan2021. She specified that she has an arthritis flare up about once a year and normally takes a Medrol dose pack. The patient's historical vaccines included an unspecified flu vaccine (MANUFACTURER UNKNOWN) on an unspecified date about ten years ago after which she had to go to the Emergency Room for right arm redness, swelling at the injection site and face swelling on right side. She did not get another flu shot for 10 years but did get one this year in Nov2020. Concomitant medication included metoprolol (MANUFACTURER UNKNOWN), flecainide acetate (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN, MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports that she experienced a light headache. She clarified that she is in an unspecified program which includes an e-diary. As part of that program (app) she was sent a text every day for a week asking if she had any side effects; a couple times she had a headache. On the eighth day (03Feb2021) she had a reaction where her right hand and wrist was painful and swollen. Caller states she couldn't move her hand without pain. Caller states she put ice on her hand Wednesday evening and this helped a little. When ice was on her hand it helped with the pain but when it was removed it came back. She also reported fingers on right were all swollen and that she does have arthritis. She further described the events as on Wednesday she started getting a little pain in her right wrist joint. She does have arthritis, but this pain was stronger, and her hand and fingers on right were all swollen in comparison to her other hand, and her knuckles seemed bigger. States that the pain got very strong and by the next morning she could barely move her arm; even though it was only her wrist that hurt, moving any part of her arm made her wrist her more, so she started icing it and took Tylenol for Arthritis 650mg Extended Release; she took it twice, one each time and reported that it probably didn't work. Caller clarifies statement about it probably not working; stating that she didn't notice a difference after taking the Tylenol. She asked if these events, occurring eight days after the vaccine could be vaccine side effects or is this just a flare up on her arthritis that is unrelated to the vaccine. She added that she had been doing a lot of "chopping" while cooking on the night that this happened so that may have caused the flare up. She has a Medrol pack on hand for things like this (4mg tablets). She started it today and took two tablets before breakfast and one tablet at lunch. She states that it has already made a difference in her pain. She stated her concern, however, which is that she found that taking a steroid could affect the vaccine if taken before getting the vaccine, and right now she is in-between the two doses. Her second dose is scheduled for 16Feb2021. She inquired as to if she can finish this dose pack without messing up the vaccine. The clinical outcome of headache was reported as recovered. The clinical outcomes of hand swelling, wrist pain, hand pain and swelling of wrists were reported as not recovered. The clinical outcomes of arthritis flare up, swelling of fingers and could not move her arm were unknown.
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| 75 | 2021-03-08 | back pain |
Back pain; extremely painful back muscle spasms; minor pain; This is a spontaneous report from a con...
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Back pain; extremely painful back muscle spasms; minor pain; This is a spontaneous report from a contactable consumer (patient). A 75 -year-old female patient (not pregnant at time of vaccination) received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9265), via an unspecified route of administration (on right arm) on 30Jan2021 12:30 (at the age of 75 -years-old), single dose for COVID-19 immunization. Concomitant medication included levothyroxine sodium (L THYROXINE), rosuvastatin, magnesium. Back pain, extremely painful back muscle spasms. Started minor pain 3 days after vaccine didn't associate it with vaccination, very painful and spasms on day 6. Have not had any back injury or strain that patient was aware of. It was reported that adverse events started 04Feb2021 19:00. Patient just wanted to be sure if ok to take 2nd vaccination. The outcome of the events was not recovered. No treatment given for any of the adverse events. The events were assessed as non-serious by the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
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| 75 | 2021-03-09 | joint pain, muscle pain |
nausea, muscle and joint aches, chill, headache, insomnia, dizziness, itchiness, swollen glands, bra...
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nausea, muscle and joint aches, chill, headache, insomnia, dizziness, itchiness, swollen glands, brain fog, rosacea,
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| 75 | 2021-03-10 | muscular weakness, neck pain |
One week after the vaccine, the pain was intense on my left side of neck, my left arm was weak and ...
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One week after the vaccine, the pain was intense on my left side of neck, my left arm was weak and had burning pain and my scalp was on fire. Four days later, the blisters appeared.
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| 75 | 2021-03-11 | joint pain |
101 degree fever, chills, headache, joint aching for a little over 24 hours. Fever broke around 24 h...
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101 degree fever, chills, headache, joint aching for a little over 24 hours. Fever broke around 24 hours. Fatigued for 72 hours. Treated with Tylenol. Hemorrhaged a blood vessel in right eyeball, not yet resolved. Seeking medical consultation today.
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| 75 | 2021-03-11 | joint pain | Pain in knees and hips |
| 75 | 2021-03-11 | joint pain | Mild headache; fatigue; joint aches; unsettled stomach; overall not well that lasted for 7 days |
| 75 | 2021-03-12 | back pain |
After 15 minutes of receiving the shot the patient was preparing to leave when she developed a sharp...
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After 15 minutes of receiving the shot the patient was preparing to leave when she developed a sharp pain that began in her upper left back then radiated to her mid chest. Chest pain lasted about 2 minutes before dissipating. Bp 133/71 heart rate in the 70's and O2 sat 97%
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| 75 | 2021-03-12 | muscle pain, joint pain |
2:00 p.m. day of injection - suddenly very tired; 6:00 p.m. heart pounding; 7:00 p.m. blood pressure...
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2:00 p.m. day of injection - suddenly very tired; 6:00 p.m. heart pounding; 7:00 p.m. blood pressure spiked to 181/93 (headache); 9:00 p.m. blood pressure dropped to 112/53 - then chills, muscle/joint pain, felt very unwell 3/7/2021 - small red itchy spot appeared on belly 3/9/2021 - full blown itchy red rash on belly
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| 75 | 2021-03-13 | joint pain |
1st vaccine on 02/03/2021 left arm, had no side affects. 2nd vaccine on 02/24/2021, on second day, ...
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1st vaccine on 02/03/2021 left arm, had no side affects. 2nd vaccine on 02/24/2021, on second day, injection site got red, swollen, had hard knot, and deep itch at injection site right arm. On third day started getting brain fog, had hard time concentrating and felt extremely tired. Redness, swelling, hard knot, and deep itching has gone away. Still have a bit of brain fog but getting better. Knee joints are hurting. I got most of my energy back. It took 9 days for redness and swelling to go down. I did not seek treatment for symptoms.
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| 75 | 2021-03-14 | muscular weakness |
Red bump on my forehead; it feels like kind of sore when I touch it; Red bump on my forehead; it fee...
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Red bump on my forehead; it feels like kind of sore when I touch it; Red bump on my forehead; it feels like kind of sore when I touch it; She is getting red bumps today on the part where she got injected; Sore arm; I get this pain in my pointer finger in my right hand; A little weakness in my right leg; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 75-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 06Feb2021 (age at the time of vaccination was 75-years-old) as a single dose for covid-19 immunisation. Medical history included high blood pressure, osteoporosis and overactive bladder. The patient concomitant medications were not reported. The previously had first dose (first shot) of BNT162B2 for covid-19 immunisation and had sore arm. It was reported that she is getting red bumps today (on 07Feb2021) on the part where she got injected. The consumer stated after second shot also, I had no symptoms except for sore arm on an unspecified date in Feb2021. The only thing that I noticed which was from second shot and which was really crazy is, once in a while I get this pain in my pointer finger in my right hand and that was it, it comes and it goes. But today, and in the last couple of days I noticed a little weakness in my right leg, but today when I went to work somebody said what is that big red bump on your forehead and I looked and there was a big red circle, there was a bump, like a real bump on my forehead. I didn't hide it, I didn't even think if it was allergic as I only had a banana before I went to work and a cup of coffee which I have lot of time. I am wondering if this bump that I have on my forehead which looks ridiculous and it is a big red bump, like a tumor bump, it feels like kind of sore when I touch it, is from the vaccine because I haven't had anything but the vaccine." Consumer stated, "Main thing I am concerned about is the big red bump on my forehead." Treatment: Consumer stated, "I never had that before, it is very slight. The main thing was the bump on my head that came today and I didn't have it when I left the house. I didn't hit my head or anything. I just took two Tylenol and an allergy pill in case if it was some kind of allergy." The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 75 | 2021-03-15 | back pain |
1st time no effect. 2nd time swollen and redness and pain at injection site. The shot stung bad goin...
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1st time no effect. 2nd time swollen and redness and pain at injection site. The shot stung bad going in. Excruciating pain in lower back. Drank lots of water, took Liquid Ibuprofen Children's liquid 2 tablespoons every 6 hours. Heating Pad on lower back. Still have effect two day later but not as bad. Swelling going down but still red. . and used heating pad.
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| 75 | 2021-03-16 | joint pain, neck pain |
Subacute onset of bilateral cervical neck pain radiating to left shoulder with paraesthesia and sens...
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Subacute onset of bilateral cervical neck pain radiating to left shoulder with paraesthesia and sensory neuropathy including burning pain not associated with activity, not ameliorated with rest, NSAIDs or Tylenol, not worsened with movement. No associated trauma, No constitutional Symptoms. Symptoms are most consistent with transverse myelitis
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| 75 | 2021-03-16 | muscle pain |
pt states that she starts nodding on and off due to extreme fatigue. She doesn't feel well and has...
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pt states that she starts nodding on and off due to extreme fatigue. She doesn't feel well and has trouble walking says she thinks its because her muscles are hurting. She says she doesnt feel right but doesnt know how to describe. Pt states she has had these symptoms going on about a month.
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| 75 | 2021-03-17 | joint pain |
Had chills all day of vaccine One week later chills on and off mot severe as first day Developed pai...
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Had chills all day of vaccine One week later chills on and off mot severe as first day Developed pain on rt side abdomen a week later which went from rt side abdomen now I. Hip the pain is constant and a week later nauseas in the morning
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| 75 | 2021-03-17 | joint pain |
The next day I had joint aches, fever (100.6), tiredness, sleepiness and no appetite. It lasted one...
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The next day I had joint aches, fever (100.6), tiredness, sleepiness and no appetite. It lasted one full day.
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| 75 | 2021-03-17 | back pain |
Nausea, emesis, headach, exacerbation of chronic low back pain. The patient explains that she has be...
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Nausea, emesis, headach, exacerbation of chronic low back pain. The patient explains that she has been experiencing the nausea since her COVID-19 vaccination
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| 75 | 2021-03-17 | neck pain |
pt experienced dizziness & neck pain following the vaccination. pt. denies any other s/s. resolved...
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pt experienced dizziness & neck pain following the vaccination. pt. denies any other s/s. resolved with comfort & calming measures. BP: 152/75, HR: 81, RR: 18. Medic paresent.
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| 75 | 2021-03-18 | neck pain, joint pain |
Soreness began five full days after injection in my left arm. Excruciating soreness starting from th...
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Soreness began five full days after injection in my left arm. Excruciating soreness starting from the base of my neck across the left shoulder down my upper arm to the elbow and below. It lasted for 7 days and then the soreness left as fast as it began.
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| 75 | 2021-03-19 | joint pain |
Right shoulder pain with limited movement since her COVID vaccine 3 weeks ago. MRI - revealed a tend...
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Right shoulder pain with limited movement since her COVID vaccine 3 weeks ago. MRI - revealed a tendon tear -degenerative arthrosis- issues with rotator cuff Patient also has tingling in her fingers. Suspect SIRVA (Shoulder Injury received from vaccine administration) as an issue to her already present shoulder issues. Plays tennis frequently Spoke with patient and she is doing fine other than pain from the site
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| 75 | 2021-03-20 | muscle pain, joint pain |
injection site pain; massive redness; swelling; bad headache; muscle and joint pain; muscle and join...
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injection site pain; massive redness; swelling; bad headache; muscle and joint pain; muscle and joint pain; tiredness; feeling unwell; This is a spontaneous report received from a contactable consumer. A 75-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on Right arm on 04Feb2021 02:45 PM at single dose.Patient Medical history included arthritis, hypertension, osteopenia. Historical vaccine included first dose of bnt162b2 via an unspecified route of administration (lot number: EL9265) on left arm on 14Jan2021 04:30 PM at Single Dose for COVID-19 immunisation. Concomitant medication included Amlodipine Besylate 2.5mg, Citalopram 10, captopril (METOPRIL). On 04Feb2021 22:30 patient experienced injection site pain, massive redness, swelling, bad headache, muscle and joint pain, muscle and joint pain, tiredness, feeling unwell after vaccination. patient was not pregnant, No treatment received for AE, patient had not Covid tested post vaccination, patient had allergies to Codine. Outcome of events was recovering. Information on the lot/batch number has been requested.
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| 75 | 2021-03-20 | muscle pain |
Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen ...
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Injection site pain; Muscle pain; front and back of my chest hurts; Chills; Feeling unwell; Swollen lymph nodes that hurts like crazy; Swollen lymph nodes that hurts like crazy; arm got sore; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 31May2021), via an unspecified route of administration on 03Feb2021 (at the age of 75 years) as single dose for covid-19 immunisation; potassium chloride (KLOR-CON M10), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included ongoing type 2 diabetes and ongoing high blood pressure. Concomitant medications included metformin; atorvastatin; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ). Consumer stated she got her Covid inoculation last Wednesday and in Feb2021, she was experiencing symptoms, adverse reactions. She had injection site pain still, muscle pain, her lungs are fine but when she breathe her front and back of her chest hurts. She had chills. She did not think she had a fever but she was definitely feeling unwell and the most difficult thing was swollen lymph nodes that hurts like crazy. She cannot read this too well. Lot was 2CI or EI EL3302 expires 31May2021. Her arm got sore but today she really started may be yesterday experiencing this muscle pain and the lymph stuff going on. Consumer stated she had no treatment. The last time her doctor gave her this new medication because she had run out of her potassium. It was called Klor-con M10 tablet. For lab work, consumer stated she did not know but right before she went there they took some blood and when the doctor gave her the Klor thing, she had a violent reaction to it. she threw up and had a lot of diarrhea and she have not taken it since. Results of lab work was unknown. The action taken in response to the events for potassium chloride was unknown. Outcome of events was unknown. Information about lot/batch number has been requested.
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| 75 | 2021-03-22 | joint pain |
Arm got sore and soreness moved to clavicle area in about 2-3 days. Then, lymph nodes around clavica...
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Arm got sore and soreness moved to clavicle area in about 2-3 days. Then, lymph nodes around clavical area became swollen and stayed swollen for about 2 weeks but are getting better now. No treatment needed and did not go to MD. Note: vaccine could be lot EU6200 because not sure of writing.
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| 75 | 2021-03-22 | joint pain |
~24 hours after injection, injection site became swollen, sore and itchy, and experienced extreme fa...
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~24 hours after injection, injection site became swollen, sore and itchy, and experienced extreme fatigue and joint pain lasting ~48 hours. Over following 3 days, arm swelling expanded to ~5" diameter with hard center and warm to touch, sore and itchy. Still swollen on Day 4 but beginning to resolve. Fatigue and joint pain resolved by end of Day 3.
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| 75 | 2021-03-24 | musculoskeletal discomfort, muscle pain |
all face including eyes swollen and red; all face including eyes swollen and red; skin got creepy, d...
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all face including eyes swollen and red; all face including eyes swollen and red; skin got creepy, dry, itchy; injection site pain and was swollen a lot; little dizziness; nausea; Muscle pain more on back side of shoulder towards neck-unbearable pain; headache; neck disfigured; rash; injection site pain; brain fog big time - disorientated, felt like brain getting damage; I'm desperate; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: solution for injection, Lot no: EN5318) via intramuscular at left arm on 19Feb2021 at 03:10 (at the age of 75-years-old) at single dose for covid-19 immunisation (at hospital). Patient medical history not reported. Concomitant medications included levothyroxine; 0.075 mg once daily for hypothyroid since 20 years; ongoing and trazodone 100 mg 1 tab daily since 20 years; ongoing. On 19Feb2021 the patient experienced injection site pain and was swollen a lot, little dizziness, nausea, muscle pain more on back side of shoulder towards neck-unbearable pain, headache, all face including eyes swollen and red, all face including eyes swollen and red, skin got creepy, dry, itchy, brain fog big time - disorientated, felt like brain getting damage, she was desperate, skin got creepy, dry and itchy. my face and neck was disfigured that don't want my children and grant children see my face. Rash-swelling, itchy and flaky skin, got a little better on 01Mar, but I still have creepy skin, flackey, itchy around eye and eyelids were swollen and dry and felt like have stones rolling in my eyes and my brain fog was very bad. I want to know if my skin will ever get better. Patent took vit-d and all the vit. Covid. Patient received treatment as OTC, Tylenol, ibuprofen, aleve. No covid prior vaccination. The reporter reported seriousness criteria as non-serious. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 75 | 2021-03-26 | joint pain, muscle pain |
extreme fatigue, headache, muscle pain, joint pain, nasal congestion, swollen glands, runny nose, 5 ...
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extreme fatigue, headache, muscle pain, joint pain, nasal congestion, swollen glands, runny nose, 5 days sneezing 2 days--all others EVERYDAY through today TX: Tylenol 3 days, Aleve 2, days continued
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| 75 | 2021-04-01 | muscle pain, joint pain | increasing joint pain, chills, fatigue, muscle pain |
| 75 | 2021-04-03 | joint pain |
All the symptoms of COVID minus the chest congestion/does not know if she might have caught COVID-19...
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All the symptoms of COVID minus the chest congestion/does not know if she might have caught COVID-19; All the symptoms of COVID minus the chest congestion/does not know if she might have caught COVID-19; her temperature went up to 102 degrees; terrible joint pains; she could not stay awake at all; diarrhea; nauseousness; headache; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration, administered in the left arm on 12Feb2021 08:30 as a single dose for COVID-19 immunisation. Medical history included dental care from an unknown date and unknown if ongoing. No concomitant drugs were reported. The patient previously received penicillin as prophylaxis prior to dental care. The patient previously received the first dose of BNT162b2 in Jan2021 (about 3 weeks prior to second dose) (Lot Number: unknown) via an unspecified route of administration in the upper left arm for COVID-19 immunisation. The patient was administered her second dose of BNT162b2 on 12Feb2021. She initially had no reaction. Then on 12Mar2021, (about 3 weeks after second dose of BNT162b2), the patient experienced all symptoms of COVID minus chest congestion, described as temperature went up to 102 degrees; terrible joint pains; could not stay awake at all; diarrhea; nauseousness; headache. Patient called her doctor and thought she could get COVID test, but the doctor said she does not need it and told her not to worry. They automatically diagnosed the patient with late side effects. Doctor thinks it is late side effects of BNT162b2 because there are cases where the doctor has seen 3 weeks to a month out of people having side effects. She has had no known exposure to any infected persons; She has been isolating 99 percent of the time since this started. She went out a couple of times to the store but she was masked and did not get near anyone; The patient does not know if she might have caught COVID-19 infection and wonders if with these event symptoms, she might have caught a milder case of COVID. The patient reported that right now her temperature was 99.5 degrees. She did not use any antipyretic. The patient was recovering from the event, temperature went up to 102 degrees. Outcome of the events, all symptoms of COVID minus chest congestion/does not know if she might have caught COVID-19, temperature went up to 102 degrees; terrible joint pains; could not stay awake at all; diarrhea; nauseousness; headache was unknown. Information about lot/batch number has been requested.
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| 75 | 2021-04-17 | back pain |
Extreme pain right arm, leg and upper back. Emergency room ordered CT scans and MRI's. That resulte...
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Extreme pain right arm, leg and upper back. Emergency room ordered CT scans and MRI's. That resulted in cervical C3 thru C7 epidural mass. Hemilaminectomy for evacuation of hematoma on 3-17-2021. C5-C6 discectomy anterior cervical w/ fusion 3-18-2021. Resulting complications were unexplained atrial fibrillation 3-21-2021, Ongoing rehab appointments for right arm and leg numbness.
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| 75 | 2021-04-17 | muscle pain, joint pain |
cellulitis; Bacterial skin infection; right arm where I got the injection turning all red and swolle...
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cellulitis; Bacterial skin infection; right arm where I got the injection turning all red and swollen; arm swelling; bursitis; Muscle pain; joint pain in elbow; the bruise have been flamed; Feeling hot; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) at the age of 75-years-old, via an unspecified route of administration in right arm on 13Mar2021 at single dose for COVID-19 immunization. Medical history included diabetic type 2 for probably 13-14 years, sleep apnea for 20 years (2001), arthritis in 2005 (probably 12-14 years), and blood pressure abnormal (reported as blood pressure). Concomitant medications included metformin, sertraline, alprazolam, sitagliptin (JANUVIA), oxybutynin, insulin glargine (LANTUS), lisinopril for blood pressure abnormal (reported as blood pressure), and cortisone for arthritis. The patient received the vaccine on 13Mar2021 in the afternoon and within 24 to 30 hours, the next day (14Mar2021), her right arm, where the vaccine was administered turned all red and swollen and her elbow also hurt. She went to the emergency room because she felt it was a reaction to the vaccine. They told her that it was a bacterial skin infection, an adverse effect of an initial encounter to the vaccine, arm swelling and bursitis caused by that, muscle pain and join pain in elbow and then she guessed it was like cellulitis. They gave her ROCEPHIN at the emergency room and then a couple days later, it wasn't getting any better and it was all the way down to her wrist. She went to immediate care center and received an antibiotic. She was also given 2 more prescription of antibiotics and told that it had to be administered with the antibiotics to get rid of the reactions. It has finally pretty much cleared up with the antibiotics if they hadn't put her in an immediate care and put her on intravenous medications. They were really concerned because it was going to get into sepsis or something. At first, the patient thought that it was just inflamed, then it was skin infection and then adverse effect from the initial encounter of the vaccine. She had been on the antibiotics for 10 days when it finally cleared, but the elbow was still sore and it hurts a lot, but the fluid was drained by an orthopedic doctor. She was given 2 different types of antibiotics plus a shot into her buttocks. It's a little sore because she was informed that "the bruise have been flamed" on Mar2021. When she went to emergency, first they give her 1 gm ROCEPHIN and then switched antibiotic to DURICEF and to BACTRIM DS, and advised to continue monitoring and if swelling and redness was progressive or worse, then go to emergency room again. She went to emergency room on 16Mar2021, the medicine given was doxycycline and then she was seen by an orthopedic physician today where the fluid was drained from her elbow but swelling and redness was progressively getting worst and she was feeling hot on Mar2021. So, she went to the immediate care. Overall, consistent to cellulitis of right upper arm strongly includes to go to the ER but the patient had something else and had to go right then. And then, she was given 1 gm ROCEPHIN and then switched to DURACEF and BACTRIM. She came back to the ER on the same day. It was kind of 2 things, like the redness and skin infection which currently was cellulitis. Doxycycline was what they told her to get, that's what they gave her at the emergency room, doxycycline hyclate. And then said to follow-up with her primary care which she did and that was on 17Mar2021. She looked at it and then they told her to see an orthopedic surgeon and she saw him on the 18Mar2021. They just thought that the antibiotics, that's why he gave her 2 different prescriptions plus the shot in the buttocks because he said if this will not be cured with the antibiotics, she'll end up in a hospital. And then it was raft and it took her 10 days to recover. And he marked little black dots to show where wasn't and if it goes beyond that then call us because it was spreading. The outcome of the events bruise and feeling hot was unknown, not recovered for joint pain, and recovered on 24Mar2021 for all other events. The events required emergency room visit/ physician office visit.
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| 75 | 2021-04-21 | muscular weakness, muscular weakness |
Initial reaction to vaccine in following days were weakness in legs with high fever. On 4/18/2021, ...
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Initial reaction to vaccine in following days were weakness in legs with high fever. On 4/18/2021, she experienced pain in chest, shortness of breath and high blood pressure. Called 911 and ambulance arrived to transport her to Medical Center. She was diagnosed with congestive heart failure. No other symptons or ailments that could have led to this event. Doctor couldn't find any blockages or any other indicators. Upon discussion with doctor we decided to report as a potential adverse event since no other factors present leading to congestive heart failure. She was treated with lasix and released on 4/21/2021.
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| 75 | 2021-04-30 | bone pain, muscle pain |
Body pains; Muscles and bone aches; Muscles and bone aches; Headache; Fatigue; This is a spontaneous...
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Body pains; Muscles and bone aches; Muscles and bone aches; Headache; Fatigue; This is a spontaneous report received from a contactable consumer (patient). This non-pregnant 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP7534) via an unspecified route of administration in the left arm on 29Mar2021 at 9:30 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies from an unknown date and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to the COVID vaccine. Concomitant medications included citalopram hydrobromide (CELEXA), carvedilol, allergy pill, and fish oil, all from unknown dates for unknown indications. The patient previously received prochlorperazine edisylate (COMPAZINE), azithromycin, and fluoxetine hydrochloride (PROZAC), all from unknown dates for unknown indications and experienced allergies; the patient previously received the first dose of BNT162B2 (lot number not reported) on 08Mar2021 at 09:45 (at the age of 75-years-old) for COVID-19 immunisation. On 30Mar2021 at 02:30 the patient experienced body pains consisting of muscle and bone aches, headache and fatigue. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of body pains consisting of muscle and bone aches, headache and fatigue were recovering. It was also reported that since vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 75 | 2021-05-07 | musculoskeletal stiffness |
Tiredness; Tightness in her left leg that felt like a tunicate was left on; Chills on her left side ...
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Tiredness; Tightness in her left leg that felt like a tunicate was left on; Chills on her left side from her foot to her neck; Sore Left Arm; Chills; Wasn't feeling herself; Rash on the left side of her face; itchy; face felt like it was hot; Rash on the left side of her face; itchy; face felt like it was hot; Rash on the left side of her face; itchy; face felt like it was hot; This is a spontaneous report received from a contactable nurse (Patient herself). A 75-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via unknown route of administration on 03Apr2021 (Lot Number: ER8729, Expiry date: Jul 2021) as single dose for COVID-19 immunization. The patient medical history was breast cancer. The patient historical vaccine included BNT162B2 on (LOT:EJ1686 Expiration: 31MAR2021) on 13 Mar 2021 for COVID-19 immunization. The patient had no family history. The patient concomitant medications were not reported. The patient experienced chills on 04Apr2021, sore left arm on 13Apr2021, Rash on the left side of her face; itchy; face felt like it was hot on Apr2021, chills on her left side from her foot to her neck: on 17Apr2021, Tiredness on an unknown date and tightness in her left leg that felt like a tunicate was left on 17Apr2021, wasn't feeling herself Apr2021. The patient stated she wanted to send pictures of her rash on her face that her dermatologist diagnosed last Tuesday as a Covid Vaccine side effect. She had the first dose of the vaccine on 13Mar2021 and the second dose on 03Apr2021. They were both done at (withheld). With the first, she had no side effects, other than a sore left arm. The second she had a sore arm and a couple of chills at first. Then two weeks post second vaccination she wasn't feeling herself, and she went to see a primary about that, but that wasn't a definite that it was side effects from the vaccine. Then, the following week on a Thursday she got a rash about the same time but it was getting itchy so she decided someone should look at it. At first she thought it was from her mask, but it was only on the left side of her face. Caller states she wrote a message to her doctor about not feeling well but she didn't connect all of the other symptoms. She went to her primary for the chills on her left side from her foot to her neck and just not feeling like herself. She had a tightness in her left leg that felt like a tunicate was left on. Her face felt like it was hot. States it was really very weird and she was very tired. The tiredness comes and goes. States she was doing interviews yesterday for a long time, virtual interviews and by 12 noon she felt so tired and took a nap and felt out of sorts. She Didn't show her the rash because she thought it was just from her mask and she wasn't a dermatologist. Didn't mention it to her primary. States she tried to cancel the appointment but said she needed to come see her anyway. Thursday she had another appointment so she called the dermatologist when it started to itch and she said to the office, should she be worried. At first, said no time, and reported to doctor and fit her in at 13:30 and she looked at it and said it is really impressive for being 2 weeks old and thinks it is Covid vaccine related. Didn't know if she should report it or not. Maybe it is something. Was thinking the Covid rash was extensive. She still has the tiredness. It reminds her of the tiredness she had after radiation for breast cancer. States it wasn't during the radiation, but 4-5 weeks later and lasted about a month. States the tiredness is not from a lack of sleep, it is like a veil comes over her. States if she has taken 10 naps in her whole life, that is a lot for her and that didn't help. Treatment: Gel for the Rash; states for her leg issue the doctor ordered an MRI to rule out a back or disc problem. States she didn't put it together, one said it might be and another side not sure. At first she was offered the Moderna and she changed when they offered the Pfizer, because of the breast issues from the Moderna. Curious to see at some point if point if other people are experiencing rashes on their faces. Caller states she didn't know what type of rash was common, she assumed it was more of a bodily rash. Tetanus back in the Fall or maybe July thinks last July, she had GI stuff and her physician wasn't particularly believing it was from that. The event tiredness wsa assessed as serious (Medically significant), and tightness in her left leg that felt like a tunicate was left considered serious (Disability). The all other events were assessed as non-serious. The patient had physicians room visit (PCP and dermatologist) and not had emergency room visit. The causality assessment was unknown for all events. The outcome of the event rash on the left side of her face; itchy; face felt like it was hot and tiredness was not recovered, The outcome of all other events was recovered. Additional information requested.; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect vaccine BNT162B2 to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 75 | 2021-05-11 | muscular weakness |
The client had the 2nd dose of Pfizer BioNtech COVID vaccine on 2/19/2021. On Sunday following the ...
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The client had the 2nd dose of Pfizer BioNtech COVID vaccine on 2/19/2021. On Sunday following the injection she started to experience joint and muscle weakness from her waist all the way down her legs. She is still having symptoms which has affected her daily living and caused difficulty with tasks such as getting dressed and putting on shoes.
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| 75 | 2021-05-12 | rheumatoid arthritis, groin pain, arthritis |
Seen in office on 4/30/21 for abdominal pain, question of diverticulitis Hospitalized 5/3 for lower ...
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Seen in office on 4/30/21 for abdominal pain, question of diverticulitis Hospitalized 5/3 for lower left quadrant pain and groin pain. Had urine culture and CT abdomen/pelvis. Admitted for observation, received hydration and medications for pain control. Discharged next day. Seen by rheumatologist on 5/5/21 for severe left groin pain. Otherwise her inflammatory arthritis appears to be no worse than before or perhaps slightly better. Per rheumatologist, he is unsure if the left groin pain is related to rheumatoid arthritis and given the intensity and severity it could be unrelated. Had MRI of hip on 5/6/21 - results were normal Seen at Urgent Care on 5/8 - provider suggested pain could be related to rheumatoid arthritis flare due to COVID vaccination. Per this provider, there is anecdotal evidence of apparent flares of gout and worsening of chronic autoimmune and rheumatologic conditions. However, that has been more typically in 2-3 time frame from immunization administration. Patient was cautioned against assigning any definite causation. Pt's pain has been very thoroughly investigated to date. I have first reassured them that I see no evidence for interim life or limb threatening process. Pain management is complicated by her chronic anticoagulation for afib, and by her reported dizziness with opioids. Although she has good ROM of her left hip without apparent provocation of pain, I still suspect this is primarily an arthritic pain flare. I have politely declined to prescribe any stronger opioid at this point. Pt, spouse, and I have discussed prednisone, with relative contraindication from her xarelto. She is desperate to try something else, and acknowledges increased risk of bleeding with co-administration. They have asked my experience with post-COVID vaccination syndromes. I have discussed the anecdotal conversations among provider group re: apparent flares of gout and worsening of chronic autoimmune and rheumatologic conditions. However, that has been more typically in 2-3 time frame from immunization administration, and I have cautioned them on assigning any definite causation.
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| 75 | 2021-05-14 | joint pain |
blurred vision; seeing blue and pink flashes in both eyes; seeing blue and pink flashes in both eyes...
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blurred vision; seeing blue and pink flashes in both eyes; seeing blue and pink flashes in both eyes; lightheaded; tingling feeling from knees to feet; got disoriented; joints aching, knees and arms; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 06Apr2021 08:20 am (Batch/Lot Number: ENB200) as single dose at the age of 75-year-old for COVID-19 immunisation. The patient medical history and concomitant medications were none. No history of all previous immunization with BNT162B2. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). On 06Apr2021, 10 minutes after she received the vaccine, she patient experienced blurred vision, seeing blue and pink flashes in both eyes, she was lightheaded, tingling feeling from knees to feet, got disoriented, joints aching, knees and arms. The events required a visit to Emergency Room. The events were considered medically significant. The outcome of joints aching, knees and arms was recovered on 27Apr2021, of all other events was recovered on 06Apr2021. The course of events was as follows: 10 minutes after she received the vaccine, she experienced blurred vision, seeing a blue and pink flashing in both eyes, she was lightheaded, from her knees down to her feet had a tingling feeling, and she got disoriented. She told her family member something was wrong with her and they got the EMS. The EMS checked her vital signs and suggested to take her to the main campus Emergency Room center. After the knees and arms stopped tingling, different side effects came up on her as she was sitting and waiting for 15 minutes. Patient did not know how long her eyes flashed exactly, but it stopped the same day. Patient had had some differences with her legs, like her joints aching. It lasted from 06Apr2021 to 27Apr2021 until she had to go back for the next vaccine. The joint pain/achiness in legs and arm lasted for 3 weeks on and off. Patient was not hospitalized. No relevant tests performed. Patient has an appointment scheduled with her physician on following Monday. She was scheduled to go back 27Apr2021 for second dose. No follow-up attempts are needed. No further information is expected.
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